FrancophonIA/ELRC3.0 huggingface dataset:
English: Adjustment of the starting Pazenir dose is not required for patients with mild to moderate renal impairment (estimated creatinine clearance ≥30 to <90 ml/min).
Danish: Justering af startdosis af Pazenir er ikke nødvendig for patienter med let til moderat nedsat nyrefunktion (estimeret kreatininclearance ≥ 30 til < 90 ml/min).
English: Two hundred and twenty nine patients treated with human serum albumin-paclitaxel nanoparticles in the randomized, controlled clinical trial were evaluated for safety.
Danish: 229 patienter, der blev behandlet med nanopartikler bestående af humant serumalbumin-paclitaxel i det randomiserede, kontrollerede kliniske studier, blev evalueret med hensyn til sikkerhed.
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed for their ability to tolerate Pazenir in combination with gemcitabine with special consideration to performance status, co-morbidities and increased risk of infections (see section 4.2 and 4.8).
Danish: Patienter i alderen 75 år og ældre med adenokarcinom i pancreas bør nøje vurderes for deres evne til at tolerere Pazenir i kombination med gemcitabin med særlig opmærksomhed på performancestatus, komorbiditeter og øget infektionsrisiko (se pkt.
English: Uncommon: Contusion Rare: Radiation recall phenomenon, radiation pneumonitis
Danish: Ikke almindelig: Kontusion Sjælden: Radiation recall-fænomen, pneumonitis ved strålebehandling
English: The median relative dose intensity of human serum albumin-paclitaxel nanoparticles was 81%.
Danish: Den mediane relative dosisintensitet for nanopartikler bestående af humant serumalbumin-paclitaxel var 81%.
English: Hepatic impairment has no effect on mean paclitaxel Cmax.
Danish: Nedsat leverfunktion har ingen virkning på den gennemsnitlige paclitaxel-Cmax.
English: • Pain and swelling in the nose, skin infections, infection due to catheter line
Danish: • Smerte og hævelse i næse, hudinfektioner, infektion som følge af det intravenøse kateter
English: Reconstituted dispersion For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Rekonstitueret dispersion Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of human serum albumin-paclitaxel nanoparticles in metastatic breast cancer.
Danish: Data fra 106 patienter, der indgik i to enkeltarmede, ublindede studier og fra 454 patienter, der blev behandlet i et randomiseret fase III sammenligningsstudie understøtter brugen af nanopartikler bestående af humant serumalbumin-paclitaxel ved metastaserende brystkræft.
English: Reduce to next lower dose levela; discontinue treatment if ADR persists
Danish: Reducer til det næste lavere dosisniveaua, seponer behandlingen, hvis bivirkningen varer ved
English: A multicenter, multinational, randomized, open-label study was conducted in 861 patients to compare human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine monotherapy as firstline treatment in patients with metastatic adenocarcinoma of the pancreas.
Danish: Der blev udført et multicenter, multinationalt, randomiseret, åbent studie hos 861 patienter for at sammenligne nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin med gemcitabin-monoterapi som førstelinjebehandling hos patienter med metastatisk adenokarcinom i pancreas.
English: • Pain at site of tumour, death of the tumour
Danish: • Smerter på tumorstedet, tumordød
English: After first reconstitution, the dispersion should be filled into an infusion bag immediately.
Danish: Efter den første rekonstitution bør dispersionen fyldes i en infusionspose med det samme.
English: R Nadir ANC <500/mm3 for > 1 week
Danish: Nadir-ANC < 500/mm3 i > 1 uge
English: The effectiveness and safety of human serum albumin-paclitaxel nanoparticles in patients with central nervous system (CNS) metastases has not been established.
Danish: Effekten og sikkerheden ved behandling med nanopartikler bestående af humant serumalbumin-paclitaxel hos patienter med metastaser i centralnervesystemet (CNS) er ikke blevet klarlagt.
English: Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Danish: Det anbefales ikke at indgive paclitaxel samtidigt med lægemidler, der vides at inducere enten CYP2C8 eller CYP3A4 (f.eks. rifampicin, carbamazepin, phenytoin, efavirenz, nevirapin), da virkningen kan blive kompromitteret på grund af lavere eksponering for paclitaxel.
English: For the treated population, the median relative dose intensity for gemcitabine was 75% in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm and 85% in the gemcitabine arm.
Danish: For den behandlede population var den mediane relative dosisintensitet for gemcitabin 75% i nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin-armen og 85% i gemcitabin-armen.
English: Because the toxicity of paclitaxel can be increased with hepatic impairment, administration of Pazenir in patients with hepatic impairment should be performed with caution.
Danish: Da paclitaxels toksicitet kan øges ved nedsat leverfunktion, skal Pazenir gives med forsigtighed til patienter med nedsat leverfunktion.
English: Delay of next cycle due to persistent neutropenia2 (Nadir
Danish: Udsættelse af næste cyklus på grund af vedvarende neutropeni2
English: Population pharmacokinetic analysis for human serum albumin-paclitaxel nanoparticles included patients with ages ranging from 24 to 85 years old and shows that age does not significantly influence the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Danish: En populationsfarmakokinetisk analyse af nanopartikler bestående af humant serumalbumin-paclitaxel inkluderede patienter i aldersintervallet fra 24 til 85 år og viser, at alder ikke har en signifikant indflydelse på paclitaxels maksimale eliminationshastighed og systemiske eksponering (AUC og Cmax).
English: Pazenir should not be administered until neutrophil counts recover to >1500 cells/mm3.
Danish: Pazenir bør ikke administreres, før neutrofiltallet atter er > 1.500 celler/mm3.
English: Dose adjustments during treatment of non-small cell lung cancer Pazenir should not be administered on Day 1 of a cycle until absolute neutrophil count (ANC) is ≥1500 cells/mm3 and platelet count is ≥100,000 cells/mm3.
Danish: Dosisjusteringer i løbet af behandling af ikke-småcellet lungecancer Pazenir bør ikke administreres på Dag 1 i en cyklus, før det absolutte neutrofiltal (ANC) er ≥ 1.500 celler/mm3, og trombocyttallet er ≥ 100.000 celler/mm3.
English: • if you experience breathing problems, like shortness of breath or dry cough.
Danish: • hvis du får vejrtrækningsbesvær, f.eks. stakåndethed eller tør hoste.
English: Resume Pazenir at reduced dose when peripheral neuropathy improves to Grade 0 or 1 (see section 4.2).
Danish: Genoptag Pazenir med reduceret dosis, når perifer neuropati forbedres til grad 0 eller 1 (se pkt.
English: Patients with moderate (total bilirubin >1.5 to ≤3 x ULN) or severe (total bilirubin >3 to ≤5 x ULN) hepatic impairment have a 22% to 26% decrease in the maximum elimination rate of paclitaxel and approximately 20% increase in mean paclitaxel AUC compared with patients with normal hepatic function.
Danish: Patienter med moderat (total bilirubin > 1,5 til ≤ 3 x øvre normalværdi) eller svært (total bilirubin > 3 til ≤ 5 x øvre normalværdi) nedsat leverfunktion har en 22% til 26% reduktion i paclitaxels maksimale eliminationshastighed og en ca. 20% forhøjet gennemsnitlig paclitaxel-AUC, sammenlignet med patienter med normal leverfunktion.
English: Uncommon: Thrombotic thrombocytopenic purpura
Danish: Ikke almindelig: Trombotisk trombocytopenisk purpura
English: Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose.
Danish: Efter administration anbefales det, at den intravenøse slange skylles med natriumchlorid 9 mg/ml (0,9%) injektionsvæske for at sikre administration af hele dosis.
English: Powder for dispersion for infusion.
Danish: Pulver til infusionsvæske, dispersion.
English: The active substance is paclitaxel.
Danish: Aktivt stof: paclitaxel.
English: Anaemiaa,b Neutropenia a,b Thrombocytopeniab,c a 405 patients assessed in human serum albumin-paclitaxel nanoparticles/gemcitabine-treated group b 388 patients assessed in gemcitabine-treated group c 404 patients assessed in human serum albumin-paclitaxel nanoparticles/gemcitabine-treated group
Danish: Neutropenia,b Trombocytopenib,c a 405 patienter vurderet i gruppen behandlet med nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin b 388 patienter vurderet i gruppen behandlet med gemcitabin c 404 patienter vurderet i gruppen behandlet med nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin
English: In a repeat dose study with 12 patients receiving human serum albumin-paclitaxel nanoparticles administered intravenously at 260 mg/m2, intrapatient variability in AUC was 19% (range = 3.21%37.70%).
Danish: I et studie med 12 patienter, der fik gentagne doser af nanopartikler bestående af humant serumalbumin-paclitaxel på 260 mg/m2 i.v., var den intraindividuelle variabilitet i AUC 19% (interval 3,21-37,70%).
English: After reconstitution, the reconstituted dispersion in the infusion bag should be used immediately.
Danish: Efter rekonstitution bør den rekonstituerede dispersion i infusionsposen anvendes med det samme.
English: Dose adjustments during treatment of pancreatic adenocarcinoma
Danish: Dosisjustering i løbet af behandlingen af adenokarcinom i pancreas
English: The study compared human serum albumin-paclitaxel nanoparticles in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer.
Danish: Studiet sammenlignede nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med carboplatin med solvensbaseret paclitaxel i kombination med carboplatin som førstelinjebehandling hos patienter med fremskreden ikke-småcellet lungecancer.
English: The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Pazenir infusions.
Danish: Det er ikke nødvendigt at anvende specielle DEHP-frie infusionsbeholdere eller administrationssæt til at klargøre eller indgive Pazenir-infusioner.
English: Of the 431 patients with pancreatic adenocarcinoma who were randomized to receive human serum albumin-paclitaxel nanoparticles in combination with gemcitabine, the majority (93%) were white, 4% were black and 2% were Asian.
Danish: Ud af de 431 patienter med adenokarcinom i pancreas, der blev randomiseret til nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin, var hovedparten (93 %) hvide, 4 % var sorte og 2 % var asiatiske.
English: Of the 17 cases of pneumonitis reported in patients treated with human serum albumin-paclitaxel nanoparticles in combination with gemcitabine, 2 had a fatal outcome.
Danish: Ud af de 17 tilfælde af pneumonitis, som blev rapporteret hos patienter i behandling med nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin, havde 2 dødelig udgang.
English: In patients with metastatic breast cancer, after a 30-minute infusion of human serum albuminpaclitaxel nanoparticles at 260 mg/m2, the mean value for cumulative urinary excretion of unchanged active substance accounted for 4% of the total administered dose with less than 1% as the metabolites 6α-hydroxypaclitaxel and 3'-p-hydroxypaclitaxel, indicating extensive non-renal clearance.
Danish: Efter 30-minutters infusion af nanopartikler bestående af humant serumalbumin-paclitaxel ved 260 mg/m2 til patienter med metastatisk brystkræft udgjorde den gennemsnitlige kumulative udskillelse af uomdannet aktivt stof i urinen 4% af den totale administrerede dosis med under 1% som metabolitterne 6α -hydroxypaclitaxel og 3'-p-hydroxypaclitaxel, hvilket indikerer omfattende ikkerenal clearance.
English: Withhold doses until fever resolves and ANC ≥ 1500; resume at next lower dose levela
Danish: Afbryd dosis, indtil feberen går væk, og ANC ≥ 1.500, genoptag med det næste lavere dosisniveaua
English: In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving human serum albumin-paclitaxel nanoparticles.
Danish: Generelt var hyppigheden og sværhedsgraden af neurotoksicitet dosisafhængig hos patienter, der fik nanopartikler bestående af humant serumalbumin-paclitaxel.
English: Gemcitabine Dose
Danish: Gemcitabin dosis
English: If Pazenir dispersion contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Hvis Pazenir-dispersionen kommer i kontakt med huden, skal huden straks vaskes grundigt med vand og sæbe.
English: The recommended dose of Pazenir is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
Danish: Den anbefalede dosis Pazenir er 260 mg/m2 administreret intravenøst over 30 minutter hver 3. uge.
English: The frequencies of adverse reactions associated with the administration of human serum albuminpaclitaxel nanoparticles are listed in Table 6 (human serum albumin-paclitaxel nanoparticles as monotherapy) and Table 7 (human serum albumin-paclitaxel in combination with gemcitabine), and Table 9 (human serum albumin-paclitaxel nanoparticles in combination with carboplatin).
Danish: Hyppighederne af bivirkninger forbundet med administration af nanopartikler bestående af humant serumalbumin-paclitaxel er angivet i Tabel 6 (nanopartikler bestående af humant serumalbumin-paclitaxel som monoterapi), og i Tabel 7 (humant serumalbumin-paclitaxel i kombination med gemcitabin) og i Tabel 9 (nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med carboplatin).
English: For any other Grade 3 or 4 non-haematologic toxicity, interrupt treatment until the toxicity improves to ≤ Grade 2, then restart treatment according to the guidelines in Table 5.
Danish: Ved alle grad 2 eller 3 ikke-hæmatologiske toksiciteter afbrydes behandlingen, indtil toksiciteten forbedres til ≤ grad 2, dernæst genstartes behandlingen i henhold til retningslinjerne i Tabel 5.
English: Rare: Cystoid macular oedema2
Danish: Sjælden: Cystoidt makulaødem2
English: Very common: Decreased appetite Common: Dehydration
Danish: Meget almindelig: Nedsat appetit Almindelig: Dehydrering
English: In patients aged 75 years and older who received human serum albumin-paclitaxel nanoparticles and gemcitabine, there was a higher incidence of serious adverse reactions and adverse reactions that led to treatment discontinuation (see section 4.4).
Danish: Hos patienter på 75 år og ældre, der fik nanopartikler bestående af humant serumalbumin-paclitaxel og gemcitabin, var der en højere forekomst af alvorlige bivirkninger og bivirkninger, der førte til seponering af behandlingen (se pkt.
English: Single-arm open-label studies
Danish: Enkeltarmede, ublindede studier
English: HRA+G/G (95%Cl)
Danish: HRA+G/G (95% Cl)a P-værdib
English: Pazenir is indicated as monotherapy for breast cancer, in combination with gemcitabine for pancreatic adenocarcinoma, or in combination with carboplatin for non-small cell lung cancer (see section 4.1).
Danish: Pazenir er indiceret som monoterapi ved brystkræft, i kombination med gemcitabin ved adenokarcinom i pancreas eller i kombination med carboplatin ved ikke-småcellet lungecancer (se pkt.
English: • medicines used to help you lower blood lipid levels (e.g. gemfibrozil)
Danish: • medicin, der anvendes til at sænke niveauet af lipider (fedt) i blodet (f.eks. gemfibrozil)
English: Survival Rate % (95% CI) at
Danish: Overlevelsesrate % (95% CI) efter
English: Non-small cell lung cancer A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Danish: Et randomiseret, åbent multicenterstudie blev udført hos 1.052 kemoterapi-naïve patienter med Stadie IIIb/IV ikke-småcellet lungecancer.
English: For ≥ Grade 3 peripheral neuropathy, withhold treatment until resolution to ≤ Grade 1.
Danish: Ved ≥ grad 3 perifer neuropati afbrydes behandlingen indtil bedring til ≤ grad 1.
English: In one study, human serum albumin-paclitaxel nanoparticles were administered as a 30-minute infusion at a dose of 175 mg/m2 to 43 patients with metastatic breast cancer.
Danish: I ét studie blev nanopartikler bestående af humant serumalbumin-paclitaxel indgivet som en 30-minutters infusion i en dosis på 175 mg/m2 til 43 patienter med metastaserende brystkræft.
English: Pneumonitis occurred in 1% of patients when human serum albumin-paclitaxel nanoparticles was used as monotherapy and in 4% of patients when Pazenir was used in combination with gemcitabine.
Danish: Pneumonitis opstod hos 1% af patienterne, når nanopartikler bestående af humant serumalbumin-paclitaxel blev anvendt til monoterapi, og hos 4% af patienterne, når Pazenir blev anvendt i kombination med gemcitabin.
English: There is no relevant use of human serum albumin-paclitaxel nanoparticles in the paediatric population in the indication of metastatic breast cancer or pancreatic adenocarcinoma or non-small cell lung cancer.
Danish: Det er ikke relevant at anvende nanopartikler bestående af humant serumalbumin-paclitaxel hos den pædiatriske population til indikationerne metastaserende brystkræft eller adenokarcinom i pancreas eller ikke-småcellet lungecancer.
English: Grade 4 cutaneous toxicity, diarrhoea, or mucositis
Danish: Grad 4 kutan toksicitet, diarré eller mukosit
English: 26.5 [18.98, 34.05] (n = 132) 13.2 [7.54, 18.93] (n = 136) 0.006a
Danish: Responsrate [95% CI] (%) > Førstelinjebehandling 26,5 [18,98; 34,05] (n = 132) 13,2 [7,54; 18,93] (n = 136) 0,006a
English: The majority of alopecia events occurred less than one month after initiation of human serum albumin-paclitaxel nanoparticles.
Danish: De fleste tilfælde af alopeci forekom inden for en måned efter behandlingsstart med nanopartikler bestående af humant serumalbumin-paclitaxel.
English: GA-2031 Haarlem Netherlands
Danish: GA-2031 Haarlem Holland
English: Day 15: If Day 8 doses were reduced:
Danish: Dag 15: Hvis Dag 8 doser blev reduceret:
English: Pharmacokinetic data are not available for patients with total bilirubin >5 x ULN or for patients with metastatic adenocarcinoma of the pancreas (see section 4.2).
Danish: Der foreliggger ingen farmakokinetiske data for patienter med total bilirubin > 5 x øvre normalværdi eller for patienter med metastatisk adenokarcinom i pancreas (se pkt.
English: • Difficulty in breathing
Danish: • Åndedrætsbesvær
English: • Pain in a joint or joints
Danish: • Smerter i et eller flere led
English: • Low levels of potassium in the blood
Danish: • Lavt kaliumniveau i blodet
English: Upon diagnosis of cystoid macular oedema, treatment with Pazenir should be discontinued.
Danish: Hvis cystoidt makulaødem diagnosticeres, skal Pazenir seponeres.
English: Grade 2 or 3 cutaneous toxicity Grade 3 diarrhoea Grade 3 mucositis ≥ Grade 3 peripheral neuropathy Any other Grade 3 or 4 non- haematologic toxicity
Danish: Grad 3 mukosit ≥ Grad 3 perifer neuropati Alle andre grad 3 eller 4 ikkehæmatologiske toksiciteter
English: Cutaneous Toxicity:
Danish: Kutan toksicitet:
English: Stability of the reconstituted dispersion in the infusion bag
Danish: Stabilitet af den rekonstituerede dispersion i infusionsposen
English: Inspect the dispersion in the vial for particulate matter.
Danish: Inspicer dispersionen i hætteglasset for bundfald.
English: The effect of hepatic impairment on population pharmacokinetics of human serum albumin-paclitaxel nanoparticles was studied in patients with advanced solid tumours.
Danish: Virkningen af nedsat leverfunktion på populationsfarmakokinetikken af nanopartikler bestående af humant serumalbumin-paclitaxel blev undersøgt hos patienter med fremskredne solide tumorer.
English: Very common: Dehydration, decreased appetite, hypokalaemia
Danish: Meget almindelig: Dehydrering, nedsat appetit, hypokaliæmi
English: • Acute kidney failure
Danish: • Akut nyresvigt
English: Reconstituted Pazenir dispersion should be administered intravenously using an infusion set incorporating a 15 µm filter.
Danish: Den rekonstituerede Pazenir-dispersion bør administreres intravenøst via et infusionssæt med et indsat 15 µm filter.
English: If you are male patient, you are advised not to father a child during and up to six months after treatment and you should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Pazenir.
Danish: Mænd frarådes at gøre kvinder gravide under og i op til seks måneder efter behandlingen, og de bør søge rådgivning om opbevaring af sæd forud for behandlingen på grund af risikoen for permanent sterilitet efter behandling med Pazenir.
English: Death or progression, n (%) Median PFS (95% CI) (months) HRA/T (95% CI)
Danish: Død eller progression, n (%) Median PFS (95% CI) (måneder) HRA/T (95% CI)
English: Table 1: Dose level reductions for patients with pancreatic adenocarcinoma Dose level
Danish: Tabel 1: Reduktion i dosisniveau for patienter med adenokarcinom i pancreas Dosisniveau
English: In a study in patients with advanced solid tumours, the pharmacokinetic characteristics of paclitaxel following human serum albumin-paclitaxel nanoparticles administered intravenously at 260 mg/m2 over 30 minutes were compared with those following 175 mg/m2 of the solvent-based paclitaxel injection administered over 3 hours.
Danish: I et studie af patienter med fremskredne, solide tumorer blev de farmakokinetiske karakteristika af paclitaxel efter intravenøs indgift af 260 mg/m2 nanopartikler bestående af humant serumalbumin-paclitaxel, over 30 minutter sammenlignet med karakteristikaene efter 175 mg/m2 af den solvensbaserede paclitaxelindsprøjtning givet over tre timer.
English: Solvent- based paclitaxel was administered to patients (N=531) at a dose of 200 mg/m2 as an intravenous infusion over 3 hours with standard premedication, immediately followed by carboplatin administered intravenously at AUC = 6 mg•min/mL.
Danish: Solvensbaseret paclitaxel blev administreret til patienter (N = 531) med en dosis på 200 mg/m2 som intravenøs infusion i løbet af 3 timer med standard-præmedicinering, umiddelbart efterfulgt af intravenøst administreret carboplatin med en dosis på AUC = 6 mg•min/ml.
English: Beginning immediately after the end of human serum albumin-paclitaxel nanoparticles administration, carboplatin at a dose of AUC = 6 mg•min/mL was administered intravenously on Day 1 only of each 21-day cycle.
Danish: Umiddelbart efter afsluttet administration af nanopartikler bestående af humant serumalbumin-paclitaxel blev carboplatin administreret intravenøst med en dosis på AUC = 6 mg•min/ml på Dag 1 i hver 21-dages cyklus.
English: Thus patients receiving Pazenir should be vigilantly monitored by physicians for the occurrence of cardiac events.
Danish: Patienter, der får Pazenir, bør derfor kontrolleres nøje for udvikling af hjertesymptomer.
English: For Grade 2 or 3 cutaneous toxicity, Grade 3 diarrhoea, or Grade 3 mucositis, interrupt treatment until the toxicity improves to ≤ Grade 1, then restart treatment according to the guidelines in Table 5.
Danish: Ved grad 2 eller 3 kutan toksicitet, grad 3 diarré eller grad 3 mukosit skal behandlingen afbrydes, indtil toksiciteten forbedres til ≤ grad 1, dernæst genstartes behandlingen i henhold til retningslinjerne i Tabel 5.