FrancophonIA/ELRC3.0 huggingface dataset:
English: 2 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Danish: 2 Pneumonitis evalueret ved brug af SMQ interstitiel lungesygdom (bredt defineret)
English: • medicines used to treat seizures (epilepsy) (e.g. carbamazepine, phenytoin)
Danish: • medicin, der anvendes mod krampeanfald (epilepsi) (f.eks. carbamazepin, phenytoin)
English: After ruling out infectious etiology and upon making a diagnosis of pneumonitis, permanently discontinue treatment with Pazenir and gemcitabine and promptly initiate appropriate treatment and supportive measures (see section 4.2).
Danish: Efter infektiøs ætiologi er udelukket og pneumonitis diagnosticeret, seponeres Pazenir og gemcitabin permanent, og passende behandling og støttebehandling påbegyndes straks (se pkt.
English: Results for overall response rate and time to disease progression, and progression-free survival and survival for patients receiving > 1st-line therapy, are shown below.
Danish: Den samlede responsrate, tid til sygdomsprogression, progressionsfri overlevelse og samlet overlevelse for patienter, der fik > førstelinjebehandling, er vist nedenfor.
English: Animal studies with human serum albumin-paclitaxel nanoparticles showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Danish: Dyreforsøg med nanopartikler bestående af humant serumalbumin-paclitaxel viste irreversible, toksiske virkninger på de mandlige forplantningsorganer ved klinisk relevante eksponeringsniveauer.
English: Following human serum albumin-paclitaxel nanoparticles administration to patients with solid tumours, paclitaxel is evenly distributed into blood cells and plasma and is highly bound to plasma proteins (94%).
Danish: Efter administration af nanopartikler bestående af humant serumalbumin-paclitaxel til patienter med solide tumorer fordeles paclitaxel ligeligt i blodceller og plasma, og det er bundet til plasmaproteiner i høj grad (94%).
English: Sensory neuropathy occurs frequently with human serum albumin-paclitaxel nanoparticles, although development of severe symptoms is less common.
Danish: Sensorisk neuropati forekommer hyppigt ved behandling med nanopartikler bestående af humant serumalbumin-paclitaxel, selvom udvikling af svære symptomer er mindre almindeligt.
English: The most common clinically significant adverse reactions associated with the use of human serum albumin-paclitaxel nanoparticles have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
Danish: De hyppigste klinisk signifikante bivirkninger forbundet med anvendelse af nanopartikler bestående af humant serumalbumin-paclitaxel har været neutropeni, perifer neuropati, artralgi/myalgi og gastrointestinale symptomer.
English: There was a statistically significant improvement in OS for patients treated with human serum albumin-paclitaxel nanoparticles/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates.
Danish: Der var en statistisk signifikant forbedring i OS hos patienter, der blev behandlet med nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin versus gemcitabin alene, med 1,8 måneders stigning i median OS, 28% samlet reduktion i risiko for død, 59% forbedring i 1-års overlevelse og 125% forbedring i 2-års overlevelsesrater.
English: Erlotinib should not be coadministered with Pazenir plus gemcitabine (see section 4.5).
Danish: Erlotinib bør ikke administreres sammen med Pazenir plus gemcitabin (se pkt.
English: The safety and efficacy of human serum albumin-paclitaxel nanoparticles in children and adolescents aged 0-17 years has not been established.
Danish: Sikkerhed og virkning af nanopartikler bestående af humant serumalbumin-paclitaxel hos børn og unge i alderen 0-17 år er ikke klarlagt.
English: Uncommon: Hepatomegaly
Danish: Ikke almindelig: Hepatomegali
English: Paclitaxel is principally eliminated by hepatic metabolism and biliary excretion.
Danish: Paclitaxel elimineres primært via levermetabolisering og galdeudskillelse.
English: Pazenir in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.
Danish: Pazenir i kombination med gemcitabin er indiceret til førstelinjebehandling af voksne patienter med metastatisk adenokarcinom i pancreas.
English: For non-small cell lung cancer patients treated with paclitaxel and carboplatin, the median time to first occurrence of Grade 3 treatment related peripheral neuropathy was 121 days, and the median time to improvement from Grade 3 treatment related peripheral neuropathy to Grade 1 was 38 days.
Danish: Hos patienter med ikke-småcellet lungecancer i behandling med paclitaxel og carboplatin var mediantiden til første forekomst af behandlingsrelateret grad 3 perifer neuropati 121 dage, og mediantiden til forbedring af behandlingsrelateret grad 3 perifer neuropati til grad 1 var 38 dage.
English: Patients in the human serum albumin-paclitaxel nanoparticles/carboplatin arm had a significantly higher overall response rate compared with patients in the control arm: 33% versus 25%, p = 0.005 (Table 12).
Danish: Patienter i nanopartikler bestående af humant serumalbumin-paclitaxel/carboplatin-armen havde en signifikant højere samlet responsrate sammenlignet med patienter i kontrolarmen: 33% versus 25%, p = 0,005 (Tabel 12).
English: Based on non-compartmental PK analysis, the plasma clearance of paclitaxel with human serum albumin-paclitaxel nanoparticles was larger (43%) than that following a solvent-based paclitaxel injection and its volume of distribution was also higher (53%).
Danish: Baseret på en non-kompartmental farmakokinetisk analyse var plasmaclearance af paclitaxel med nanopartikler bestående af humant serumalbumin-paclitaxel større (43%) end clearance efter en solvensbaseret paclitaxelindsprøjtning, og fordelingsvolumenen var også højere (53%).
English: It should not be substituted for or with other paclitaxel formulations.
Danish: Det bør ikke erstatte eller erstattes med andre paclitaxelformuleringer.
English: • Pazenir is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas.
Danish: • Pazenir anvendes sammen med et lægemiddel, der kaldes gemcitabin, hvis du har metastatisk kræft i bugspytkirtlen.
English: The paclitaxel exposure (AUC) increased linearly from 2653 to 16736 ng.hr/ml following dosing from 80 to 300 mg/m2.
Danish: Eksponeringen for paclitaxel (AUC) øgedes lineært fra 2.653 til 16.736 ng∙t/ml efter dosering fra 80 til 300 mg/m2.
English: This analysis included patients with normal hepatic function (n=130), and pre-existing mild (n=8), moderate (n=7), or severe (n=5) hepatic impairment (according to NCI Organ Dysfunction Working Group criteria).
Danish: Denne analyse omfattede patienter med normal leverfunktion (n = 130) og præeksisterende let (n = 8), moderat (n = 7) eller svært (n = 5) nedsat leverfunktion (i henhold til kriterierne fra NCI Organ Dysfunction Working Group).
English: This is possibly due to paclitaxel not being trapped in Cremophor EL micelles as with solvent-based paclitaxel.
Danish: Dette skyldes formentlig, at paclitaxel ikke fanges i polyethoxyleret ricinusolie (Cremophor EL) miceller, sådan som det er tilfældet med solvensbaseret paclitaxel.
English: Sepsis was reported at a rate of 5% in patients with or without neutropenia who received Pazenir in combination with gemcitabine.
Danish: Sepsis blev rapporteret med en hyppighed på 5% hos patienter med eller uden neutropeni, som fik Pazenir i kombination med gemcitabin.
English: Do not substitute for or with other paclitaxel formulations.
Danish: Må ikke erstatte eller erstattes med andre paclitaxelformuleringer.
English: Table 13: Non-inferiority analyses on progression-free survival and overall survival in randomized non-small cell lung cancer trial (intent-to-treat population)
Danish: Tabel 13: Non-inferioritetsanalyser for progressionsfri overlevelse og samlet overlevelse i et randomiseret studie af ikke-småcellet lungecancer (intent-to-treat-population)
English: • Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Danish: • Svær vævsirritation og udslæt på hud og slimhinder (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse)
English: Pazenir contains human serum albumin-paclitaxel nanoparticles of approximately 130 nm in size, where the paclitaxel is present in a non-crystalline, amorphous state.
Danish: Pazenir indeholder nanopartikler med en størrelse på ca. 130 nm, der består af humant serumalbumin, hvor paclitaxel findes i en ikke-krystallinsk, amorf tilstand.
English: Paclitaxel clearance is primarily determined by CYP2C8 and CYP3A4 mediated metabolism followed by biliary excretion, while gemcitabine is inactivated by cytidine deaminase followed by urinary excretion.
Danish: Paclitaxel-clearance bestemmes primært af CYP2C8- og CYP3A4-medieret metabolisme efterfulgt af biliær udskillelse, mens gemcitabin inaktiveres af cytidindeaminase efterfulgt af renal udskillelse.
English: Paclitaxel at doses below the human therapeutic dose was associated with low fertility when administered prior and during mating in male and female rats and foetal toxicity in rats.
Danish: Paclitaxel blev, ved doser under den terapeutiske dosis for mennesker, forbundet med lav fertilitet ved administration før og under parring hos han- og hunrotter og føtal toksicitet hos rotter.
English: Table 10: Results for overall response rate, median time to disease progression, and progression-free survival as assessed by the investigator
Danish: Tabel 10: Resultater for samlet responsrate, mediantid til sygdomsprogression og progressionsfri og samlet overlevelse, baseret på investigators vurderinger.
English: In this phase III randomized, controlled, open-label trial, adverse reactions resulting in death within 30 days of the last dose of study drug were reported for 4% of patients receiving human serum albumin-paclitaxel nanoparticles in combination with gemcitabine and for 4% of patients receiving gemcitabine monotherapy.
Danish: I dette randomiserede, kontrollerede, åbne fase III-studie, blev bivirkninger, der førte til døden i løbet af 30 dage efter den sidste dosis studiemedicin, rapporteret hos 4% af de patienterne, der fik nanopartikler bestående af humant serumalbumin-paclitaxel i kombination med gemcitabin, og hos 4% af de patienter, der fik gemcitabin-monoterapi.
English: People with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received paclitaxel attached to the human protein albumin with gemcitabine in a clinical trial lived longer than people who had only received gemcitabine.
Danish: Personer med metastatisk kræft i bugspytkirtlen (kræft i bugspytkirtlen, der har spredt sig til andre dele af kroppen), som fik paclitaxel bundet til det humane protein albumin sammen med gemcitabin i et klinisk studie, levede længere end personer, der kun fik gemcitabin.
English: • Decreased liver function, increased size of liver
Danish: • Nedsat leverfunktion, øget leverstørrelse
English: Common: Febrile neutropenia Rare: Pancytopenia
Danish: Almindelig: Febril neutropeni Sjælden: Pancytopeni
English: Therefore, in the absence of a PK drug-drug interaction study, caution should be exercised when administering paclitaxel concomitantly with medicinal products known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Danish: Da der ikke foreligger et farmakokinetisk lægemiddelinteraktionsstudie, bør der udvises forsigtighed, når paclitaxel indgives samtidigt med lægemidler, der vides at hæmme enten CYP2C8 eller CYP3A4 (f.eks. ketoconazol og andre imidazol-antimykotika, erythromycin, fluoxetin, gemfibrozil, clopidogrel, cimetidin, ritonavir, saquinavir, indinavir og nelfinavir), da paclitaxels toksicitet kan øges på grund af højere eksponering for paclitaxel.
English: • Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)
Danish: • Irriterede øjne, smertefulde øjne, røde øjne, kløende øjne, dobbeltsyn, reduceret syn eller det at se blinkende lys, sløret syn på grund af hævelse af nethinden (cystoidt makulaødem)
English: If the dispersion contacts the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Hvis dispersionen kommer i kontakt med huden, skal huden straks vaskes grundigt med vand og sæbe.
English: Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet, and hearing) favored human serum albuminpaclitaxel nanoparticles and carboplatin (p ≤ 0.002).
Danish: Ved anvendelse af gentagen måleanalyse var 3 ud af de 4 delskalaer (perifer neuropati, smerter i hænder/fødder samt hørelse) bedre for nanopartikler bestående af humant serumalbumin-paclitaxel og carboplatin (p ≤ 0,002).
English: Neurotoxicity to paclitaxel was evaluated through improvement by one grade for patients experiencing Grade 3 peripheral neuropathy at any time during therapy.
Danish: Neurotoksicitet forårsaget af paclitaxel blev evalueret, indtil der var opnået en stigning svarende til én grad hos patienter, der oplevede grad 3 perifer neuropati på et hvilket som helst givet tidspunkt under behandlingen.
English: Pharmacokinetic/pharmacodynamic modelling using data from 125 patients with advanced solid tumours indicates that patients ≥ 65 years of age may be more susceptible to development of neutropenia within the first treatment cycle, although the plasma paclitaxel exposure is not affected by age.
Danish: Farmakokinetisk/farmakodynamisk modellering ved brug af data fra 125 patienter med fremskredne solide tumorer indikerer, at patienter ≥ 65 år kan være mere følsomme for udvikling af neutropeni i løbet af den første behandlingscyklus, selvom eksponeringen for paclitaxel i plasma ikke påvirkes af alder.
English: Based on the published literature, in vitro studies of binding to human serum proteins, (using paclitaxel at concentrations ranging from 0.1 to 50 µg/ml), indicate that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine did not affect protein binding of paclitaxel.
Danish: Baseret på den offentliggjorte litteratur indikerer in vitro-studier af binding til humane serumproteiner (med paclitaxelkoncentrationer fra 0,1 til 50 µm), hvilket indikerer, at proteinbindingen af paclitaxel ikke bliver påvirket af cimetidin, ranitidin, dexamethason eller diphenhydramin.
English: The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Pazenir infusions.
Danish: Det er ikke nødvendigt at anvende specielle di(2-ethylhexyl)phthalat (DEHP)-frie infusionsbeholdere eller administrationssæt til at klargøre eller indgive Pazenir-infusioner.
English: Male patients should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Pazenir.
Danish: Mandlige patienter bør søge rådgivning om opbevaring af sæd forud for behandling på grund af risikoen for permanent sterilitet som følge af behandling med Pazenir.
English: Pharmacokinetic/pharmacodynamic modelling using data from 125 patients with advanced solid tumours indicates that patients ≥ 65 years of age may be more susceptible to development of neutropenia within the first treatment cycle.
Danish: Farmakokinetisk/farmakodynamisk modellering af data fra 125 patienter med fremskredne solide tumorer indikerer, at patienter ≥ 65 år kan være mere følsomme for udvikling af neutropeni i løbet af den første behandlingscyklus.
English: Treatment should be directed at the major anticipated toxicities, which are bone marrow suppression, mucositis and peripheral neuropathy.
Danish: Behandlingen bør rettes mod den forventelige alvorlige toksicitet i form af knoglemarvssuppression, mukosit og perifer neuropati.
English: CI = confidence interval, HRA+G/G = hazard ratio of Paclitaxel human serum albumin-paclitaxel nanoparticles+gemcitabine/gemcitabine, pA+G/pG=response rate ratio of human serum albumin-paclitaxel nanoparticles+gemcitabine/gemcitabine a stratified Cox proportional hazard model b stratified log-rank test, stratified by geographic region (North America versus others), KPS (70 to 80 versus 90 to 100), and presence of liver metastasis (yes versus no).
Danish: CI = konfidensinterval, HRA+G/G = hazard ratio for Paclitaxel nanopartikler bestående af humant serumalbumin-paclitaxel+gemcitabin/gemcitabin, pA+G/pG=responsrate-forhold for nanopartikler bestående af humant serumalbumin-paclitaxel+gemcitabin/gemcitabin a stratificeret Cox proportional hazard-model b stratificeret log-rank-test, stratificeret ved geografisk region (Nordamerika versus andre), KPS (70 til 80 versus 90 til 100)
English: The results show that mild hepatic impairment (total bilirubin >1 to ≤1.5 x ULN) has no clinically important effect on pharmacokinetics of paclitaxel.
Danish: Resultaterne viser, at let nedsat leverfunktion (total bilirubin > 1 til ≤ 1,5 x øvre normalværdi) ikke har nogen klinisk vigtig virkning på paclitaxels farmakokinetik.
English: Peripheral Neuropathy:
Danish: Perifer neuropati:
English: Common: Cardiac failure congestive, tachycardia
Danish: Almindelig: Kongestiv hjerteinsufficiens, takykardi
English: There is limited experience of human serum albumin-paclitaxel nanoparticles/carboplatin use in patients 75 years or older.
Danish: Der er begrænset erfaring med anvendelse af nanopartikler bestående af humant serumalbumin-paclitaxel/carboplatin hos patienter 75 år og derover.
English: Each ml of Pazenir contains approximately 4.2 mg of sodium.
Danish: Hver ml Pazenir indeholder cirka 4,2 mg natrium.
English: However, a subsequent analysis in 981 patients receiving human serum albumin-paclitaxel nanoparticles monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Danish: En efterfølgende analyse hos 981 patienter, der fik monoterapi med nanopartikler bestående af humant serumalbumin-paclitaxel for metastatisk brystkræft, hvoraf 15% var ≥ 65 år, og 2% var ≥ 75 år, viste en højere forekomst af epistaxis, diarré, dehydrering, træthed og perifert ødem hos patienter ≥ 65 år.
English: 2D bar code carrying the unique identifier
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: Population pharmacokinetic analyses for human serum albumin-paclitaxel nanoparticles indicate that gender, race (Asian vs. White), and type of solid tumours do not have a clinically important effect on systemic exposure (AUC and Cmax) of paclitaxel.
Danish: Populationsfarmakokinetiske analyser af nanopartikler bestående af humant serumalbumin-paclitaxel indikerer, at køn, race (asiatisk versus hvid) og typen af solide tumorer ikke har en klinisk vigtig virkning på paclitaxels systemiske eksponering (AUC og Cmax).
English: Anaemia (Hb < 10 g/dl) was observed in 46% of patients on human serum albumin-paclitaxel nanoparticles, and was severe (Hb < 8 g/dl) in three cases.
Danish: Anæmi (Hb < 10 g/dl) blev observeret hos 46% af patienterne, der fik nanopartikler bestående af humant serumalbumin-paclitaxel, og var udtalt (Hb < 8 g/dl) i tre tilfælde.
English: MedDRA = Medical Dictionary for Regulatory Activities; SMQ = Standardized MedDRA Query (a grouping of several MedDRA preferred terms to capture a medical concept).
Danish: MedDRA = Medical Dictionary for Regulatory Activities, SMQ = Standardized MedDRA Query (en gruppering af flere foretrukne MedDRA-termer inden for et medicinsk begreb).
English: Administer Pazenir using an infusion set incorporating a 15 µm filter to avoid administration of these strands.
Danish: Administrer Pazenir via et infusionssæt med et indsat 15 µm filter for at undgå administration af disse tråde.
English: The recommended dose of carboplatin is AUC = 6 mg•min/mL on Day 1 only of each 21-day cycle, beginning immediately after the end of Pazenir administration.
Danish: Den anbefalede dosis af carboplatin er AUC = 6 mg•min/ml kun på Dag 1 i hver 21-dages cyklus umiddelbart efter, administrationen af Pazenir er gennemført.
English: If foaming or clumping occurs, the dispersion should stand for at least 15 minutes until foam subsides.
Danish: Hvis der forekommer skumdannelse eller sammenklumpning, bør dispersionen stå i mindst 15 minutter, indtil skummet lægger sig.
English: Uncommon: Breast pain
Danish: Ikke almindelig: Brystsmerter
English: Population pharmacokinetic analysis included patients with normal renal function (n=65), and preexisting mild (n=61), moderate (n=23), or severe (n=l) renal impairment (according to draft FDA guidance criteria 2010).
Danish: En populationsfarmakokinetisk analyse omfattede patienter med normal nyrefunktion (n = 65) og præeksisterende let (n = 61), moderat (n = 23) eller svært (n = l) nedsat nyrefunktion (i henhold til udkastet til kriterierne for FDA-retningslinjerne 2010).
English: • if you experience numbness, tingling, pricking sensations, sensitivity to touch, or muscle weakness;
Danish: • hvis du oplever følelsesløshed, en stikkende, prikkende fornemmelse, følsomhed over for berøring eller muskelsvaghed
English: Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with human serum albuminpaclitaxel nanoparticles.
Danish: Grad 4 neutropeni (< 500 celler/mm3) forekom hos 9% af de patienter, der blev behandlet med nanopartikler bestående af humant serumalbumin-paclitaxel.
English: The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of human serum albumin-paclitaxel nanoparticles at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
Danish: Farmakokinetikken af total-paclitaxel efter 30- og 180-minutters infusioner af nanopartikler bestående af humant serumalbumin-paclitaxel ved doseringsniveauer på 80 til 375 mg/m2 blev bestemt i kliniske studier.
English: Women of childbearing potential should have a pregnancy test prior to starting treatment with Pazenir.
Danish: Kvinder i den fertile alder skal have en graviditetstest inden start af behandling med Pazenir.
English: • if you experience any abnormal bruising, bleeding, or signs of infections such as a sore throat or a fever;
Danish: • hvis du får unormale blå mærker, blødning, eller infektionstegn såsom ondt i halsen eller feber
English: Nadir platelets <50,000/mm3
Danish: Nadir-trombocytter < 50.000/mm3
English: Fourteen percent of the patients had not received prior chemotherapy; 27% had received chemotherapy in the adjuvant setting only, 40% in the metastatic setting only, and 19% in both metastatic and adjuvant settings.
Danish: 14% af patienterne havde ikke tidligere fået kemoterapi; 27% havde alene fået kemoterapi som adjuverende behandling, 40% alene som behandling for metastaserende sygdom og 19% havde fået både adjuverende behandling og behandling for metastaserende sygdom.
English: Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on human serum albuminpaclitaxel nanoparticleswith 10% being Grade 3, and no cases of Grade 4.
Danish: Perifer neuropati (hovedsagelig grad 1 eller 2 sensorisk neuropati) blev observeret hos 68% af patienterne, der fik nanopartikler bestående af humant serumalbumin-paclitaxel; heraf var 10% grad 3, og ingen var grad 4 (se pkt.
English: The formation of these hydroxylated metabolites is catalysed by CYP2C8, CYP3A4, and both CYP2C8 and CYP3A4 isoenzymes, respectively.
Danish: Dannelsen af disse hydroxylerede metabolitter katalyseres af CYP2C8-, CYP3A4- og af henholdsvis både CYP2C8- og CYP3A4-isoenzymer.
English: • Dehydration, taste disturbance, weight loss
Danish: • Dehydrering, smagsforstyrrelser, vægttab