natgillin/translations-raw huggingface dataset:
For yderligere at bevise effekten og sikkerheden af polatuzumab vedotin i DLBCL, vil indehaveren af markedsføringstilladelsen levere studie GO39942, et randomiseret, dobbeltblindt, placebokontrolleret forsøg, der evaluerer polatuzumab vedotin i kombination med R-CHP (rituximab, cyclophosphamid, doxorubicin, prednison) versus R-CHOP hos patienter med tidligere ubehandlet diffust storcellet B-celle lymfom. 
In order to provide further evidence of efficacy and safety of polatuzumab vedotin in DLBCL, the MAH will provide Study GO39942, a randomized, double-blind, placebo controlled trial that evaluates polatuzumab vedotin in combination with R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone) versus R-CHOP in patients with previously untreated diffuse large B-cell lymphoma.
Mænd skal bruge prævention under hele behandlingen og i 6 måneder efter sidste dosis af Polivy. 
Men must use contraception during treatment and for 6 months after the last dose of Polivy.
• alvorlige infektioner 
• severe infections
Kvinder, der kan blive gravide, skal undersøges for graviditet før behandling. 
In women of childbearing potential, the pregnancy status shall be checked prior to treatment.
Kontrollér den intravenøse pose for partikler. 
Inspect the intravenous bag for particulates and discard if present.
Af mikrobiologiske hensyn, bør den tilberedte infusionsopløsning anvendes straks. 
From a microbiological point of view, the prepared solution for infusion should be used immediately.
De bivirkninger, der beskrives under dette punkt er identificeret under behandling af og opfølgning på tidligere behandlede DLBCL-patienter fra det pivotale kliniske studie, GO29365. 
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.
Polivy pulver til koncentrat til infusionsvæske, opløsning er et hvidt til let gråhvidt lyofilisat, leveret i et hætteglas. 
Polivy powder for concentrate for solution for infusion is a white to slightly greyish-white cake provided in a glass vial.
Der er rapporteret infektioner, inklusive pneumoni og andre typer infektioner, hos 53,3% af patienterne i Polivy plus BR-armen og 51,3% af patienterne i BR-armen. 
Infections, including pneumonia and other types of infections, were reported in 53.3% of patients in the Polivy plus BR arm and 51.3% of patients in the BR arm.
• Øvrige indholdsstoffer: succinsyre, natriumhydroxid, saccharose, polysorbat 20. 
• The other ingredients are: succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Polivy er udelukkende beregnet til éngangsbrug. 
Polivy is for single-use only.
På baggrund af fysiologiske, farmakokinetiske (PBPK) modelsimulationer af MMAE frigjort fra polatuzumab vedotin, kan stærke CYP3A4- og P-gp-hæmmere (fx ketoconazol) øge arealet under koncentrations-tidskurven (AUC) for ukonjugeret MMAE med 48%. 
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%.
Der er ikke udført dedikerede carcinogenicitetsstudier med polatuzumab vedotin og/eller MMAE. 
No dedicated carcinogenicity studies have been performed with polatuzumab vedotin and/or MMAE.
Hvis dosis allerede er reduceret til 1,4 mg/kg, skal behandling med Polivy seponeres. 
If a prior dose reduction to 1.4 mg/kg has occurred, discontinue Polivy.
Stærke CYP3A4-induktorer (fx rifampicin, carbamazepine, phenobarbital, phenytoin, perikon (hypericum perforatum)) kan mindske eksponeringen af ukonjugeret MMAE. 
Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenobarbital, phenytoin, St John's wort [Hypericum perforatum]) may decrease the exposure of unconjugated MMAE.
• Aktivt stof: Polatuzumab vedotin. 
• The active substance is polatuzumab vedotin.
Der blev rapporteret alvorlige bivirkninger hos 27% af de patienter, der blev behandlet med Polivy plus BR, omfattende febril neutropeni (6,7%), pyreksi (4,4%), og pneumoni (4,4%) 
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%).
Hvis der ikke er bedring til grad ≤1 inden eller på dag 14, skal behandling med Polivy seponeres. 
If not recovered to Grade ≤ 1 on or before Day 14, discontinue Polivy.
Den terminale halveringstid for acMMAE var i behandlingsserie 6 ca. 12 dage (95% KI for 8,1-19,5 dage). 
The terminal half-life at Cycle 6 was approximately 12 days (95% CI of 8.1-19.5 days) for acMMAE.
Hvis trombocytter stiger til >75.000/µl inden eller på dag 7, genoptages al behandling uden dosisreduktion. 
If platelets recover to > 75,000/µL on or before Day 7, resume all treatment without any dose reductions.
Baseret på den farmakokinetiske populationsanalyse, er der et fald i optag af ukonjugeret MMAE (AUC) efter gentagen dosering hver 3. uge. 
Based on the population PK analysis there is a decrease of plasma unconjugated MMAE exposure (AUC) after repeated every-three-week dosing.
Tabel over bivirkninger rapporteret i kliniske studier Følgende bivirkninger præsenteres efter systemorganklasse og hyppighed, defineret som: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1000 til <1/100), sjælden 
The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000).
Polivy gives i kombination med to andre lægemidler mod kræft, rituximab og bendamustin. 
Polivy is given in combination with two other cancer medicines called rituximab and bendamustine.
I Polivy plus BR-armen blev grad 3 eller højere, neutropeni, trombocytopeni og anæmi rapporteret hos henholdsvis 40%, 37,8% og 24,4% af patienterne. 
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.
Polivy er et lægemiddel mod kræft, der indeholder det aktive stof polatuzumab vedotin, 
Polivy is a cancer medicine that contains the active substance polatuzumab vedotin.
De hyppigst rapporterede bivirkninger (≥30%) hos patienter behandlet med Polivy i kombination med BR var anæmi (46,7%), trombocytopeni (46,7%), neutropeni (46,7%), træthed (40,0%), diarré (37,8%), kvalme (33,3%) og pyreksi (33,3%). 
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%).
Kontakt lægen eller sundhedspersonalet, hvis du bemærker én eller flere af følgende bivirkninger: 
Tell your doctor or nurse if you notice any of the following side effects:
Polivy skal rekonstitueres og fortyndes under aseptisk håndtering og under supervision af sundhedspersoner. 
Polivy must be reconstituted and diluted using aseptic technique under the supervision of a healthcare professional.
I Polivy plus BR-armen rapporteredes alvorlige infektioner hos 28,9% af patienterne og dødelige infektioner hos 8,9% af patienterne. 
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.
• får hovedpine 
• have headaches
Lægemiddelinteraktioner med samtidigt administrerede lægemidler, der er CYP3A4-hæmmere,substrater eller -induktorer samt samtidigt administrerede lægemidler, der er P-gp-hæmmere. 
Drug interactions with concomitant medicines that are CYP3A4 inhibitors, substrates or inducers and co-medications that are P-gp inhibitors
Drej forsigtigt hætteglasset i cirkulære bevægelser indtil lyofilisatet er helt opløst. 
Swirl the vial gently until completely dissolved.
Meget almindelig infusionsrelaterede reaktionerb a Bivirkninger forbundet med dødelig udgang b Defineret som alle bivirkninger rapporteret som relateret til forsøgsbehandling inden for 24 timer efter infusion Ikke almindelige, sjældne og meget sjældne bivirkninger: ingen 
Defined as all adverse reactions reported as related to study treatment within 24 hours after treatment infusion Uncommon, rare and very rare ADRs: none
20 ml hætteglas (farveløst type 1-glas,) lukket med stopper (fluororesinlaminat) og aluminiumsforsegling med plastikhætte, der kan vippes af, indeholdende 140 mg polatuzumab vedotin. 
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.
Median af OS i Polivy plus BR-armen var 12,4 måneder (95% KI: 9,0, NE) mod 4,7 måneder (95% KI: 3,7;8,3) i kontrol-armen. 
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.
Det estimeres, at i alt 588 patienter er behandlet med Polivy i det kliniske udviklingsprogram. 
For the clinical development program of Polivy as a whole, an estimated total of 588 patients have received Polivy.
Polivy må ikke administreres som intravenøs stød- eller bolusdosis. 
Polivy must not be administered as intravenous push or bolus.
Polivy indeholder natrium 
Polivy contains sodium
Én patient (2,2%) i Polivy plus BR-armen fik seponeret behandling på grund af infektion sammenlignet med 5,1% af patienterne i BR-armen. 
One patient (2.2%) in the Polivy plus BR arm discontinued treatment due to infection compared to 5.1% of patients in the BR arm.
Træk ved hjælp af steril sprøjte det ønskede volumen af rekonstitueret opløsning fra Polivyhætteglasset og tilsæt det til den intravenøse infusionspose. 
Withdraw the required volume of reconstituted solution from the Polivy vial using a sterile syringe and dilute into the intravenous infusion bag.
Op til 72 timer i køleskab (2°C - 8°C) eller op til 8 timer ved stuetemperatur (9°C - 25°C) 1For at sikre produktets stabilitet bør de angivne opbevaringstider ikke overskrides. 
Up to 72 hours refrigerated (2 °C − 8 °C) or up to 8 hours at room temperature (9 °C − 25 °C) 1 To ensure product stability, do not exceed specified storage durations.
Der er rapporteret gastrointestinal toksicitet hos 80,0% af patienterne i Polivy plus BR-armen sammenlignet med 64,1% af patienterne i BR-armen. 
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.
Der er set alvorlige tilfælde af levertoksicitet konsistente med cellulær leverskade, inklusive forhøjede transaminaser og/eller bilirubin, hos patienter behandlet med Polivy (se pkt. 
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).
Efter den første polatuzumab vedotin-dosis på 1,8 mg/kg er den gennemsnitlige maksimumskoncentration af acMMAE (Cmax) 803 (±233) ng/ml og arealet under koncentrations-tids-kurven fra tid nul til uendelig (AUCinf) 1860 (±966) dag•ng/ml. 
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.
Med hensyn til samtidig administration af CYP3A-hæmmere, se ptk. 
With regard to co-administration of CYP3A-inhibitors see section 4.5.
Bortset fra én patient, var ingen i Polivy plus BR-armen i den randomiserede Fase II tidligere behandlet med bendamustin. 
All except one patient in the pola+BR arm of the randomized Phase II were naïve to bendamustine treatment.
Tabel 1 Dosisændringer i Polivy ved perifer neuropati (PN) Sværhedsgrad af PN på dag 1 i en given serie 
Table 1 Polivy dose modifications for peripheral neuropathy (PN) Severity of PN on
Afbryd al behandling indtil neutrofilocytter stiger til >1000/µl. 
Withhold all treatment until ANC recovers to > 1000/µL.
Den rekonstituerede opløsning skal fremstå farveløs til lysebrun, klar til let opaliserende og ikke indeholde synlige partikler. 
The reconstituted solution should appear colourless to slightly brown, clear to slightly opalescent, and free of visible particulates.
Efter den første dosis polatuzumab vedotin på 1,8 mg/kg, er Cmax 6,82 (±4,73) ng/ml, tid til maksimal plasmakoncentration ca. 2,5 dage og den terminale halveringstid ca. 4 dage. 
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.
Polivy skal fortyndes til en endelig koncentration på 0,72-2,7 mg/ml i en intravenøs infusionspose, med et mindstevolumen på 50 ml, indeholdende 9 mg/ml natriumchlorid opløsning til injektion, 4,5 mg/ml natriumchlorid opløsning til injektion eller 5% glukose. 
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.
Denne indlægsseddel blev senest ændret <{måned ÅÅÅÅ}.> 
This leaflet was last revised in {MM/YYYY}
Brug steril sprøjte og injicér langsomt 7,2 ml sterilt vand til injektionsvæsker i hætteglasset med 140 mg Polivy for at opnå en enkeltdosis-opløsning med 20 mg/ml polatuzumab vedotin. 
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.
Median af progressionsfri overlevelse i Polivy plus BR-arm var 7,6 måneder (95% KI: 6,0; 17,0) va 2,0 måneder (95% KI: 1,5; 3,7) i kontrol-armen. 
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.
6.6 Regler for bortskaffelse og anden håndtering 
6.6 Special precautions for disposal and other handling General precautions
problemer med synet 
• problems with your eyesight.
Polivy skal rekonstitueres med sterilt vand til injektionsvæsker og fortyndes i en intravenøs infusionspose med natriumchlorid 9 mg/ml (0,9%), opløsning til injektion eller natriumchlorid 4,5 mg/ml (0,45%) opløsning til injektion eller 5% glukose inden administration. 
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.
Hjælpestoffer: Succinsyre, natriumhydroxid, saccharose, polysorbat 20. 
LIST OF EXCIPIENTS succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Kontakt straks lægen eller sygeplejersken, hvis du har: 
Tell your doctor or nurse straight away if you have:
Dette inkluderer patienter i run-in-fasen (n=6) og randomiserede patienter (n=39), som blev behandlet med Polivy i kombination med bendamustin og rituximab (BR) sammenlignet med randomiserede patienter (n=39), som kun fik BR. Medianen for patienter randomiseret til behandlingsarmen var 5 behandlingsserier, mens medianen hos patienter randomiseret til sammenligningsarmen var 3 behandlingsserier. 
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.
Der bør fastlægges procedurer for korrekt håndtering og bortskaffekse af cytotoksiske lægemidler. 
Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Polatuzumab vedotin er et CD79b-rettet antistof-lægemiddelkonjugat, som fortrinsvis afgiver et potent anti-mitotisk stof (monomethyl auristatin E eller MMAE) til B-celler, som dræber maligne B-celler. 
Polatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, which results in the killing of malignant B-cells.
I Polivy plus BR-armen rapporteredes grad 1 og grad 2 PN hos henholdsvis 26,7% og 13,3% af patienterne. 
In the Polivy plus BR arm, Grade 1 PN and Grade 2 PN were reported in 26.7% and 13.3% of patients, respectively.
Meget almindelig diarré, kvalme, obstipation, opkastning, abdominalsmerter, smerter i øvre abdomen 
Very common diarrhoea, nausea, constipation, vomiting, abdominal pain, upper abdominal pain
I BR-armen rapporteredes grad 1 og grad 2 PN hos henholdsvis 2,6% og 5,1% af patienterne. 
In the BR arm, Grade 1 and 2 PN events were reported in 2.6% and 5.1% of patients, respectively.
Mænd der behandles med Polivy skal frarådes at få børn under behandlingen og i op til 6 måneder efter sidste dosis. 
Men being treated with Polivy are advised not to father a child during treatment and for up to 6 months following the last dose.
Roche Pharma AG Tel: +49 (0) 7624 140 
Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
Patienter med tidligere allogen HSCT, centralnervesystemlymfom, transformeret indolent lymfom, grad 3b FL, signifikant kardiovaskulær eller pulmonær sygdom, aktive infektioner, ASAT eller alanin transaminase (ALAT) >2,5 øvre normalgrænse eller totalbilirubin ≥1,5 x øvre normalgrænse, creatinin >1,5 x øvre normalgrænse (eller CrCl <40 ml/min) kunne ikke inkluderes i studiet, med mindre det skyldtes underliggende lymfom. 
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.
Tabel 2 Dosisændringer i Polivy, bendamustin og rituximab ved myelosuppression Sværhedsgrad af myelosuppression på dag 1 i en given serie 
Table 2 Polivy, bendamustine and rituximab dose modifications for myelosuppression Severity of myelosuppression on
Det ikke-justerede estimat for progressionsfri overlevelse HR var 0,34. 
The unadjusted estimate for PFS HR was 0.34.
Mænd, der behandles med Polivy, bør derfor tilrådes at få præserveret og opbevaret sæd inden behandling (se pkt. 
Therefore, men being treated with Polivy are advised to have sperm samples preserved and stored before treatment (see section 4.6).
Det antistof-konjugerede MMAE (acMMAE) plasmaeksponering øges dosisproportionelt over dosisspændet 0,1 til 2,4 mg/kg polatuzumab vedotin. 
Antibody-conjugated MMAE (acMMAE) plasma exposure increased dose-proportionally over the 0.1 to 2.4 mg/kg polatuzumab vedotin dose range.
Der sås et tilfælde af PML, som var dødeligt, hos en patient i behandling med Polivy plus bendamustin og obinutuzumab. 
Progressive multifocal leukoencephalopathy (PML) One case of PML, which was fatal, occurred in one patient treated with Polivy plus bendamustine and obinutuzumab.
Embryo-føtal toksicitet 
Embryo-foetal toxicity
• Opbevares i køleskab (2°C til 8°C). 
• Store in a refrigerator (2°C - 8°C).
Meget almindelig hypokalæmi, hypokalcæmi, hypoalbuminæmi, nedsat appetit 
Very common hypokalaemia, hypocalcaemia, hypoalbuminemia, decreased appetite Nervous system disorders
• problemer med at gå 
• problems walking
Sådan gives Polivy 
How Polivy is given
Polatuzumab vedotin er et antistof-lægemiddelkonjugat bestående af det anti-mitotiske stof monomethyl auristatin E (MMAE) kovalent bundet til et CD79b-rettet monoklonalt antistof (rekombinant humaniseret immunglobulin G1 [IgG1], fremstillet i ovarieceller fra kinesisk hamster ved rekombinant DNA-teknologi). 
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).
Som med alle terapeutiske proteiner, kan patienter behandlet med polatuzumab vedotin potentielt opleve immunrespons. 
As with all therapeutic proteins, there is the potential for an immune response in patients treated with polatuzumab vedotin.
Interaktion med rituximab og bendamustin i kombination med polatuzumab vedotin 
Drug interactions of rituximab and bendamustine in combination with polatuzumab vedotin
Polivy dosis (mg/kg) x patientens vægt (kg) Rekonstitueret hætteglas-koncentration (20 mg/ml) 
Total Polivy dose (mL) to be further diluted = Polivy dose (mg/kg) X patient's weight (kg)
Rituximab og bendamustins farmakokinetik påvirkes ikke af samtidig administration af polatuzumab vedotin. 
The pharmacokinetics (PK) of rituximab and bendamustine are not affected by co-administration with polatuzumab vedotin.
• reaktioner på infusionen 
• infusion-related reactions
Hvis neutrofilocytter stiger til >1000/µl inden eller på dag 7, genoptages al behandling uden yderligere dosisreduktion. 
If ANC recovers to > 1000/µL on or before Day 7, resume all treatment without any additional dose reductions.
På grund af manglende data er der ikke fastsat en anbefalet dosis til patienter med CrCL <30ml/min. 
A recommended dose has not been determined for patients with CrCL < 30mL/min due to limited data.
Af mikrobiologiske hensyn bør den rekonstituerede opløsning anvendes straks. 
From a microbiological point of view, the reconstituted solution should be used immediately.
Mænd der behandles med dette lægemiddel skal derfor tilrådes at få præserveret sæd til opbevaring inden behandling. 
Therefore, men being treated with this medicine are advised to have sperm samples preserved and stored before treatment.
Den højeste dosis, der til dato er testet er 2,4 mg/kg, administreret som intravenøs infusion. 
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.
Hvis neutrofilocytter stiger til >1000/µl efter dag 7: 
If ANC recovers to > 1000/µL after Day 7:
Kontakt straks lægen eller sygeplejersken, hvis du: 
Tell your doctor or nurse straight away if you:
PN rapporteret i forbindelse med Polivy-behandling er primært sensorisk PN. Der er dog også rapporteret tilfælde af motorisk og sensormotorisk PN. 
PN reported with treatment with Polivy is predominantly sensory PN.
(I hvert undersøgt population med let nedsat leverfunktion (defineret som ASAT eller ALAT >1,0 til 2,5 × øvre normalgrænse eller total bilirubin >1,0 til 1,5 × øvre normalgrænse), var der en 40% stigning i ikke-konjugerede MMAE eksponerede, som ikke blev vurderet klinisk signifikant). 
Per studied population in mild hepatic impairment (defined as AST or ALT >1.0 to 2.5 × ULN or total bilirubin >1.0 to 1.5 × ULN), there was a 40% increase in unconjugated MMAE exposure, which was not deemed clinically significant.
Det giver færre røde blodlegemer, hvide blodlegemer og blodplader. 
Myelosuppression is a condition in which the production of blood cells is decreased, resulting in fewer red blood cells, white blood cells, and platelets.
polyurethan, polybutadien, acrylonitrilbutadienstyren, polycarbonat, polyetherurethan, fluorineret ethylenpropylen eller polytetrafluorethylen og med filtermembraner bestående af polyethersulfon eller polysulfon. 
In addition, no incompatibilities have been observed with infusion sets or infusion aids with product contacting materials of PVC, PE, polyurethane, polybutadiene, acrylonitrile butadiene styrene, polycarbonate, polyetherurethane, fluorinated ethylene propylene, or polytetrafluorethylene and with filter membranes composed of polyether sulfone or polysulfone.
Brug af anden medicin sammen med Polivy 
Other medicines and Polivy
6.3. for opbevaringsforhold efter rekonstitution og fortynding af lægemidlet. 
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
• Opbevar hætteglasset i den ydre karton for at beskytte mod lys. 
• Keep the container in the outer carton in order to protect from light.