FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 20 ml hætteglas (farveløst type 1-glas,) lukket med stopper (fluororesinlaminat) og aluminiumsforsegling med plastikhætte, der kan vippes af, indeholdende 140 mg polatuzumab vedotin.
English: 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.
Danish: 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.
English: For the clinical development program of Polivy as a whole, an estimated total of 588 patients have received Polivy.
Danish: Det estimeres, at i alt 588 patienter er behandlet med Polivy i det kliniske udviklingsprogram.
English: Polivy must not be administered as intravenous push or bolus.
Danish: Polivy må ikke administreres som intravenøs stød- eller bolusdosis.
English: Polivy contains sodium
Danish: Polivy indeholder natrium
English: 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.
Danish: 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.
English: Withdraw the required volume of reconstituted solution from the Polivy vial using a sterile syringe and dilute into the intravenous infusion bag.
Danish: Træk ved hjælp af steril sprøjte det ønskede volumen af rekonstitueret opløsning fra Polivyhætteglasset og tilsæt det til den intravenøse infusionspose.
English: 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.
Danish: 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.
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.
Danish: Der er rapporteret gastrointestinal toksicitet hos 80,0% af patienterne i Polivy plus BR-armen sammenlignet med 64,1% af patienterne i BR-armen.
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).
Danish: Der er set alvorlige tilfælde af levertoksicitet konsistente med cellulær leverskade, inklusive forhøjede transaminaser og/eller bilirubin, hos patienter behandlet med Polivy (se pkt.
English: 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.
Danish: 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.
English: With regard to co-administration of CYP3A-inhibitors see section 4.5.
Danish: Med hensyn til samtidig administration af CYP3A-hæmmere, se ptk.
English: All except one patient in the pola+BR arm of the randomized Phase II were naïve to bendamustine treatment.
Danish: Bortset fra én patient, var ingen i Polivy plus BR-armen i den randomiserede Fase II tidligere behandlet med bendamustin.
English: Table 1 Polivy dose modifications for peripheral neuropathy (PN) Severity of PN on
Danish: Tabel 1 Dosisændringer i Polivy ved perifer neuropati (PN) Sværhedsgrad af PN på dag 1 i en given serie
English: Österreich Roche Austria GmbH Tel: +43 (0) 1 27739
Danish: Roche Austria GmbH Tel: +43 (0) 1 27739
English: Withhold all treatment until ANC recovers to > 1000/µL.
Danish: Afbryd al behandling indtil neutrofilocytter stiger til >1000/µl.
English: The reconstituted solution should appear colourless to slightly brown, clear to slightly opalescent, and free of visible particulates.
Danish: Den rekonstituerede opløsning skal fremstå farveløs til lysebrun, klar til let opaliserende og ikke indeholde synlige partikler.
English: 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.
Danish: 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.
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.
Danish: 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.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret <{måned ÅÅÅÅ}.>
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.
Danish: 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.
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.
Danish: 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.
English: 6.6 Special precautions for disposal and other handling General precautions
Danish: 6.6 Regler for bortskaffelse og anden håndtering
English: • problems with your eyesight.
Danish: problemer med synet
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.
Danish: 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.
English: LIST OF EXCIPIENTS succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Danish: Hjælpestoffer: Succinsyre, natriumhydroxid, saccharose, polysorbat 20.
English: Tell your doctor or nurse straight away if you have:
Danish: Kontakt straks lægen eller sygeplejersken, hvis du har:
English: This includes run-in phase patients (n=6) and randomized patients (n=39) who received Polivy in combination with bendamustine and rituximab (BR) compared to randomized patients (n=39) who received BR alone.
Danish: 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.
English: Procedures for proper handling and disposal of anticancer medicinal products should be considered.
Danish: Der bør fastlægges procedurer for korrekt håndtering og bortskaffekse af cytotoksiske lægemidler.
English: 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.
Danish: 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.
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.
Danish: I Polivy plus BR-armen rapporteredes grad 1 og grad 2 PN hos henholdsvis 26,7% og 13,3% af patienterne.
English: Very common diarrhoea, nausea, constipation, vomiting, abdominal pain, upper abdominal pain
Danish: Meget almindelig diarré, kvalme, obstipation, opkastning, abdominalsmerter, smerter i øvre abdomen
English: In the BR arm, Grade 1 and 2 PN events were reported in 2.6% and 5.1% of patients, respectively.
Danish: I BR-armen rapporteredes grad 1 og grad 2 PN hos henholdsvis 2,6% og 5,1% af patienterne.
English: Men being treated with Polivy are advised not to father a child during treatment and for up to 6 months following the last dose.
Danish: Mænd der behandles med Polivy skal frarådes at få børn under behandlingen og i op til 6 måneder efter sidste dosis.
English: Puh/Tel: +358 (0) 10 554 500
Danish: Roche Oy Puh/Tel: +358 (0) 10 554 500
English: Deutschland Roche Pharma AG Tel: +49 (0) 7624 140
Danish: Roche Pharma AG Tel: +49 (0) 7624 140
English: 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.
Danish: 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.
English: Table 2 Polivy, bendamustine and rituximab dose modifications for myelosuppression Severity of myelosuppression on
Danish: Tabel 2 Dosisændringer i Polivy, bendamustin og rituximab ved myelosuppression Sværhedsgrad af myelosuppression på dag 1 i en given serie
English: The unadjusted estimate for PFS HR was 0.34.
Danish: Det ikke-justerede estimat for progressionsfri overlevelse HR var 0,34.
English: Therefore, men being treated with Polivy are advised to have sperm samples preserved and stored before treatment (see section 4.6).
Danish: Mænd, der behandles med Polivy, bør derfor tilrådes at få præserveret og opbevaret sæd inden behandling (se pkt.
English: Antibody-conjugated MMAE (acMMAE) plasma exposure increased dose-proportionally over the 0.1 to 2.4 mg/kg polatuzumab vedotin dose range.
Danish: Det antistof-konjugerede MMAE (acMMAE) plasmaeksponering øges dosisproportionelt over dosisspændet 0,1 til 2,4 mg/kg polatuzumab vedotin.
English: Progressive multifocal leukoencephalopathy (PML) One case of PML, which was fatal, occurred in one patient treated with Polivy plus bendamustine and obinutuzumab.
Danish: Der sås et tilfælde af PML, som var dødeligt, hos en patient i behandling med Polivy plus bendamustin og obinutuzumab.
English: Embryo-foetal toxicity
Danish: Embryo-føtal toksicitet
English: • Store in a refrigerator (2°C - 8°C).
Danish: • Opbevares i køleskab (2°C til 8°C).
English: Very common hypokalaemia, hypocalcaemia, hypoalbuminemia, decreased appetite Nervous system disorders
Danish: Meget almindelig hypokalæmi, hypokalcæmi, hypoalbuminæmi, nedsat appetit
English: • problems walking
Danish: • problemer med at gå
English: How Polivy is given
Danish: Sådan gives Polivy
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).
Danish: 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).
English: As with all therapeutic proteins, there is the potential for an immune response in patients treated with polatuzumab vedotin.
Danish: Som med alle terapeutiske proteiner, kan patienter behandlet med polatuzumab vedotin potentielt opleve immunrespons.
English: Drug interactions of rituximab and bendamustine in combination with polatuzumab vedotin
Danish: Interaktion med rituximab og bendamustin i kombination med polatuzumab vedotin
English: Total Polivy dose (mL) to be further diluted = Polivy dose (mg/kg) X patient's weight (kg)
Danish: Polivy dosis (mg/kg) x patientens vægt (kg) Rekonstitueret hætteglas-koncentration (20 mg/ml)
English: The pharmacokinetics (PK) of rituximab and bendamustine are not affected by co-administration with polatuzumab vedotin.
Danish: Rituximab og bendamustins farmakokinetik påvirkes ikke af samtidig administration af polatuzumab vedotin.
English: • infusion-related reactions
Danish: • reaktioner på infusionen
English: If ANC recovers to > 1000/µL on or before Day 7, resume all treatment without any additional dose reductions.
Danish: Hvis neutrofilocytter stiger til >1000/µl inden eller på dag 7, genoptages al behandling uden yderligere dosisreduktion.
English: A recommended dose has not been determined for patients with CrCL < 30mL/min due to limited data.
Danish: På grund af manglende data er der ikke fastsat en anbefalet dosis til patienter med CrCL <30ml/min.
English: From a microbiological point of view, the reconstituted solution should be used immediately.
Danish: Af mikrobiologiske hensyn bør den rekonstituerede opløsning anvendes straks.
English: Therefore, men being treated with this medicine are advised to have sperm samples preserved and stored before treatment.
Danish: Mænd der behandles med dette lægemiddel skal derfor tilrådes at få præserveret sæd til opbevaring inden behandling.
English: The highest dose tested to date is 2.4 mg/kg administered as an intravenous infusion; it was associated with a higher frequency and severity of PN events.
Danish: Den højeste dosis, der til dato er testet er 2,4 mg/kg, administreret som intravenøs infusion.
English: If ANC recovers to > 1000/µL after Day 7:
Danish: Hvis neutrofilocytter stiger til >1000/µl efter dag 7:
English: Tell your doctor or nurse straight away if you:
Danish: Kontakt straks lægen eller sygeplejersken, hvis du:
English: PN reported with treatment with Polivy is predominantly sensory PN.
Danish: PN rapporteret i forbindelse med Polivy-behandling er primært sensorisk PN. Der er dog også rapporteret tilfælde af motorisk og sensormotorisk PN.
English: 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.
Danish: (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).
English: Myelosuppression is a condition in which the production of blood cells is decreased, resulting in fewer red blood cells, white blood cells, and platelets.
Danish: Det giver færre røde blodlegemer, hvide blodlegemer og blodplader.
English: 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.
Danish: polyurethan, polybutadien, acrylonitrilbutadienstyren, polycarbonat, polyetherurethan, fluorineret ethylenpropylen eller polytetrafluorethylen og med filtermembraner bestående af polyethersulfon eller polysulfon.
English: Tlf: +45 - 36 39 99 99
Danish: Roche a/s Tlf: +45 - 36 39 99 99
English: Other medicines and Polivy
Danish: Brug af anden medicin sammen med Polivy
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Danish: 6.3. for opbevaringsforhold efter rekonstitution og fortynding af lægemidlet.
English: • Keep the container in the outer carton in order to protect from light.
Danish: • Opbevar hætteglasset i den ydre karton for at beskytte mod lys.
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.
Danish: Eksponering af ukonjugeret MMAE, den cytotoksiske bestanddel af polatuzumab vedotin, øges dosisproportionelt over dosisspændet 0,1 til 2,4 mg/kg polatuzumab vedotin.
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.
Danish: Det skal administreres som intravenøs infusion gennem separat infusionsslange med sterilt, pyrogenfrit, integreret eller indsat filter med lav proteinbinding (0,2 eller 0,22 mikrometer porestørrelse) og kateter.
English: Table 5 Summary of efficacy in patients with previously treated DLBCL from study GO29365 Polivy + bendamustine + rituximab N = 40
Danish: Tabel 5 Oversigt over virkning hos patienter med tidligere behandlet DLBCL fra studie GO29365
English: Based on the mechanism of action and nonclinical studies, polatuzumab vedotin can be harmful to the foetus when administered to a pregnant woman.
Danish: På baggrund af virkningsmekanismen og ikke-kliniske studier vurderes det, at polatuzumab vedotin kan skade fostret, hvis det administreres til en gravid kvinde.
English: 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.
Danish: Det vurderes på baggrund af den farmakokinetiske populationsanalyse, at patienter med let (CrCL 60-89 ml/min, n = 161) og moderat (CrCL 30-59 ml/min, n = 109) nedsat nyrefunktion har en optagelse af acMMAE og ukonjugeret MMAE, der svarer til det, der ses hos patienter med normal nyrefunktion (CrCL ≥90 ml/min, n = 185).
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.
Danish: Der blev rapporteret grad 3-4 hændelser hos 22,2% af patienterne i Polivy plus BR-armen sammenlignet med 12,8% af patienterne i BR-armen.
English: The polatuzumab vedotin molecule consists of MMAE covalently attached to a humanized immunoglobulin G1 monoclonal antibody via a cleavable linker.
Danish: Polatuzumab vedotin-molekylet består af MMAE kovalent bundet til et humaniseret immunglobulin G1 monoklonalt antistof via en spaltbar forbindelse.
English: Signs and symptoms of infections vary between individuals, tell your doctor or nurse straight away if you develop symptoms of an infection such as:
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du udvikler symptomer på en infektion, som for eksempel:
English: 8.9% of patients in the Polivy plus BR arm discontinued Polivy due to neutropenia compared to 2.6% of patients in the BR arm who discontinued treatment due to neutropenia.
Danish: 8,9% af patienterne i Polivy plus BR-armen fik seponeret behandling med Polivy på grund af neutropeni sammenlignet med 2,6% af patienterne i BR-armen.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution Read the package leaflet before use
Danish: Til intravenøs anvendelse efter rekonstitution og fortynding Læs indlægssedlen inden brug.
English: In non-clinical studies, polatuzumab vedotin has resulted in testicular toxicity, and may impair male reproductive function and fertility (see section 5.3).
Danish: Polatuzumab vedotin har i non-kliniske studier medført testikeltoksicitet og kan skade den mandlige reproduktionsfunktion og fertilitet (se pkt.
English: However, results of the 4-week rat toxicity study indicate the potential for polatuzumab vedotin to impair male reproductive function and fertility.
Danish: Dog indikerer et 4ugers toksicitetstudie med rotter, at polatuzumab vedotin potentielt kan nedsætte reproduktionsfunktionen og fertiliteten hos hanner.
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.
Danish: Polivy blev givet intravenøst i en dosis på 1,8 mg/kg på dag 2 i behandlingsserie 1 og på dag 1 i behandlingsserie 2-6.
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.
Danish: Bendamustin blev givet intravenøst i en dosis på 90 mg/m2 dagligt på dag 2 og 3 i behandlingsserie 1 og på dag 1 og 2 i behandlingsserie 2-6.
English: • herpes infection
Danish: • herpesinfektion
English: 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)
Danish: Op til 24 timer i køleskab (2°C - 8°C) eller op til 4 timer ved stuetemperatur (9°C - 25°C) Natriumchlorid 4,5 mg/ml (0,45%) Op til 72 timer i køleskab (2°C - 8°C) eller op til 8 timer ved stuetemperatur (9°C - 25°C)
English: These are a type of blood cells.
Danish: B-lymfocytter er en type af blodlegemer.
English: **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)
Danish: ***Stratificeret efter varighed af respons inden behandling (≤12 måneder vs >12 måneder).
English: • not feeling hungry
Danish: • manglende appetit
English: NAME OF THE MEDICINAL PRODUCT Polivy 140 mg powder for concentrate for solution for infusion.
Danish: Polivy 140 mg pulver til koncentrat.
English: 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.
Danish: Polivy skal administreres gennem separat infusionsslange med sterilt, pyrogenfrit filter med lav proteinbinding, indbygget eller indsat (0,2 eller 0,22 mikrometer porestørrelse) og kateter.
English: Rituximab was administered at 375 mg/m2 on Day 1 of Cycles 1-6.
Danish: Rituximab blev givet i en dosis på 375 mg/m2 på d ag 1 i behandlingsserie 1-6.
English: Women should discontinue breast-feeding during treatment with Polivy.
Danish: Kvinder bør ikke amme, mens de er i behandling med Polivy.
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).
Danish: Der er påvist kemisk og fysisk holdbarhed af den rekonstituerede opløsning i op til 72 timer i køleskab (2°C - 8°C) og op til 24 timer ved stuetemperatur (9°C - 25°C).
English: The infusion rate of Polivy should be slowed or interrupted if the patient develops an infusion-related reaction.
Danish: Hvis patienten udvikler en infusionsrelateret reaktion, bør infusionshastigheden af Polivy sættes ned eller infusionen afbrydes.
English: • viral infections
Danish: • virusinfektioner