FrancophonIA/ELRC3.0 huggingface dataset:
English: Some settling of the reconstituted dispersion may occur.
Danish: En vis bundfældning af den rekonstituerede dispersion kan forekomme.
English: A non-inferiority analysis was conducted for PFS and OS, with a pre-specified non-inferiority margin of 15%.
Danish: Der blev udført en efterfølgende non-inferioritetsanalyse for PFS og OS med en præspecificeret non-inferioritetsmargin på 15%.
English: Pregnant staff should not handle Pazenir.
Danish: Personale, der er gravide, bør ikke håndtere Pazenir.
English: Reconstitution of the product and administration
Danish: Rekonstitution af produktet og administration
English: Because these events have been reported voluntarily during clinical practice, true estimates of frequency cannot be made and a causal relationship to the events has not been established.
Danish: Da disse bivirkninger er blevet rapporteret frivilligt under klinisk praksis, kan der ikke foretages faktiske estimater af hyppigheden, og en kausal sammenhæng med bivirkningerne er ikke blevet fastslået.
English: Treatment was administered until disease progression or development of an unacceptable toxicity.
Danish: Behandlingen blev administreret indtil sygdomsprogression eller udvikling af uacceptabel toksicitet.
English: a Per EMA methodological considerations for PFS endpoint, missing observations or initiation of subsequent new therapy were not used for censoring.
Danish: a I henhold til metodologiske overvejelser fra EMA for PFS-endepunkt blev manglende observationer eller påbegyndelse af efterfølgende nye behandlinger ikke anvendt til censurering.
English: Tell your doctor if you are taking or have recently taken any other medicines.
Danish: Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Reduce subsequent dose only if criteria in Table 4 are met.
Danish: Reducer kun den efterfølgende dosis, hvis kriterierne i Tabel 4 er opfyldt.
English: There was no statistically significant difference in progression-free survival (by blinded radiologist assessment) and overall survival between the two treatment arms.
Danish: Der var ingen statistisk signifikant forskel i progressionsfri overlevelse (ved en blindet radiologisk vurdering) og samlet overlevelse mellem de to behandlingsarme.
English: • Decreased or increased blood pressure
Danish: • Nedsat eller forhøjet blodtryk
English: Seventy-seven percent of the patients had been previously exposed to anthracyclines.
Danish: 77% af patienterne havde tidligere været eksponeret for antracykliner.
English: Figure 1: Kaplan-Meier curve of overall survival (intent-to-treat population)
Danish: Figur 1: Kaplan-Meier-kurve for samlet overlevelse (intent-to-treat-population)
English: Each medicinal product was administered on Day 1 of each 21-day cycle.
Danish: Hvert lægemiddel blev administreret på Dag 1 i hver 21-dages cyklus.
English: The clinical relevance of this finding is uncertain.
Danish: Den kliniske relevans af dette fund er ikke kendt.
English: Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia.
Danish: Omfattende hårtab ≥ 50% forventes hos de fleste patienter, der oplever alopeci.
English: Rare: Extravasation
Danish: Sjælden: Ekstravasation
English: Lymphopenia was observed in 45% of the patients.
Danish: Lymfopeni blev observeret hos 45% af patienterne.
English: • Depression, sleep problems
Danish: • Depression, søvnproblemer
English: Progression-free Survival
Danish: Progressionsfri overlevelse
English: • Very slow pulse, heart attack
Danish: • Meget langsom puls, hjerteanfald
English: It is not known if paclitaxel is excreted in human milk.
Danish: Det er ukendt, om paclitaxel udskilles i human mælk.
English: 30 minutes on Days 1, 8 and 15 of each 21-day cycle.
Danish: 30 minutter på Dag 1, 8 og 15 i hver 21-dages cyklus.
English: • Loss of hair (the majority of cases of hair loss happened less than one month after starting paclitaxel.
Danish: • Hårtab (de fleste tilfælde af hårtab forekom inden for en måned efter behandlingsstart med paclitaxel.
English: Treatment may be resumed at the next lower dose level in subsequent cycles according to the guidelines in Table 5.
Danish: Behandlingen kan genoptages med det næste lavere dosisniveau i efterfølgende cyklusser i henhold til retningslinjerne i Tabel 5.
English: If a patient becomes febrile (regardless of neutrophil count), initiate treatment with broad spectrum antibiotics.
Danish: Hvis en patient bliver febril (uanset neutrofiltal), skal behandling med bredspektrede antibiotika påbegyndes.
English: Most of the individuals were previously exposed to cardiotoxic medicinal products such as anthracyclines, or had underlying cardiac history.
Danish: De fleste havde tidligere været eksponeret for kardiotoksiske lægemidler såsom antracykliner eller havde en underliggende hjertesygdom.
English: Medical or healthcare professionals
Danish: Læger og sundhedspersonale
English: There is no known antidote for paclitaxel overdose.
Danish: Der er ingen kendt modgift mod overdosis af paclitaxel.
English: Confirmed complete or partial overall response, n (%)
Danish: Bekræftet fuldstændigt eller delvist samlet respons, n (%)
English: Such side effects occur far less with Pazenir.
Danish: Sådanne bivirkninger forekommer meget mindre hyppigt med Pazenir.
English: This medicine has not been studied in children and adolescents, as breast cancer, pancreatic cancer and lung cancer do not occur in these age groups.
Danish: Dette lægemiddel er ikke blevet undersøgt hos børn og unge, da brystkræft, kræft i bugspytkirtlen og lungekræft ikke forekommer i disse aldersgrupper.
English: The use of gloves, goggles and protective clothing is recommended.
Danish: Anvendelse af handsker, beskyttelsesbriller og beskyttende beklædning anbefales.
English: This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions.
Danish: Denne stabilitet resulterer i hæmningen af den normale dynamiske reorganisering af netværket af mikrotubuli, der er afgørende for nødvendige cellefunktioner under interfase og mitose.
English: Abbreviations: ANC=Absolute Neutrophil Count; WBC=white blood cell
Danish: Forkortelser: ANC=Absolut neutrofiltal (ANC=Absolute Neutrophil Count); WBC=hvide blodlegemer (WBC=white blood cell)
English: Take care and speak to your doctor when taking Pazenir at the same time as any of the following:
Danish: Vær forsigtig og tal med din læge, hvis du får Pazenir samtidig med nogle af følgende:
English: Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during administration of the medicinal product.
Danish: Da der er risiko for ekstravasation, tilrådes det at overvåge infusionsstedet nøje for mulige infiltrationer under administration af lægemidlet.
English: Neutropenia is dose-dependent and a dose-limiting toxicity.
Danish: Neutropenien er dosisafhængig, og den er en dosisbegrænsende toksicitet.
English: The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose reduction.
Danish: Forekomsten af grad 1 eller 2 sensorisk neuropati kræver i almindelighed ikke dosisreduktion.
English: Contains sodium, see package leaflet for further information.
Danish: Indeholder natrium, se indlægssedlen for yderligere oplysninger.
English: Gloves, goggles and protective clothing should be used.
Danish: Handsker, beskyttelsesbriller og beskyttende beklædning bør anvendes.
English: • if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Pazenir (listed in section 6);
Danish: • hvis du er allergisk (overfølsom) over for paclitaxel eller et af de øvrige indholdsstoffer i Pazenir (angivet i punkt 6)
English: *This data is based on Clinical Study Report: CA012-0 Addendum dated Final (23 March-2005) a Chi-squared test b Log-rank test
Danish: *Disse data er baseret på den kliniske studierapport: CA012-0 Addendum dateret Endelig udgave (23. Marts 2005) a Chi2-test b Log-rank test
English: Patient-reported taxane toxicity was assessed using the 4 subscales of the Functional Assessment of Cancer Therapy (FACT)-Taxane questionnaire.
Danish: Patientrapporteret taxantoksicitet blev vurderet ved hjælp af de 4 delskalaer i taxanspørgeskemaet Functional Assessment of Cancer Therapy (FACT).
English: Pazenir is for intravenous use.
Danish: Pazenir er til intravenøs anvendelse.
English: Use of filters with a pore size less than 15 µm may result in blockage of the filter.
Danish: Hvis filtre med en porestørrelse mindre end 15 µm anvendes, kan det medføre, at filteret tilstoppes.
English: Unopened vials 2 years
Danish: Uåbnede hætteglas 2 år
English: Paclitaxel has minor or moderate influence on the ability to drive and use machines.
Danish: Paclitaxel påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: In addition, elimination of paclitaxel shows an inverse correlation with total bilirubin and a positive correlation with serum albumin.
Danish: Desuden viser eliminationen af paclitaxel en invers korrelation med total bilirubin og en positiv korrelation med serumalbumin.
English: Then, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete redispersion of any powder occurs.
Danish: Derefter bør hætteglasset forsigtigt og langsomt hvirvles og/eller vendes på hovedet i mindst to minutter, indtil fuldstændig redispersion af alt pulver.
English: Pharmacokinetic interactions between Pazenir and gemcitabine have not been evaluated in humans.
Danish: Farmakokinetiske interaktioner mellem Pazenir og gemcitabin er ikke blevet evalueret hos mennesker.
English: There are very limited data on the use of paclitaxel in human pregnancy.
Danish: Der er meget utilstrækkelige data fra anvendelse af paclitaxel under graviditeten hos mennesker.
English: Myelosuppression events, peripheral neuropathy events, and arthralgia were more frequent in patients 65 years or older compared to patients younger than 65 years of age.
Danish: Hændelser med myelosuppression, perifer neuropati og artralgi var hyppigere hos patienter i alderen 65 år eller ældre sammenlignet med patienter under 65 år.
English: Patients with pre-existing neuropathy of Grade ≥ 2 or serious medical risk factors involving any of the major organ systems were excluded.
Danish: Patienter med eksisterende neuropati af grad ≥ 2 eller alvorlige medicinske risikofaktorer, der involverede nogle af de vigtige organsystemer, blev ekskluderet.
English: • Increased liver function tests
Danish: • Forhøjede prøver for leverfunktionen
English: • Decreased blood pressure when standing up, coldness in your hands and feet
Danish: • Nedsat blodtryk når du rejser dig op, kolde hænder og fødder
English: If a hypersensitivity reaction occurs, the medicinal product should be discontinued immediately, symptomatic treatment should be initiated, and the patient should not be rechallenged with paclitaxel.
Danish: Hvis der forekommer en overfølsomhedsreaktion, bør behandlingen straks afbrydes, symptomatisk behandling bør påbegyndes, og patienten bør ikke udsættes for paclitaxel igen.
English: 2Maximum of 7 days post scheduled Day 1 dose of next cycle.
Danish: 2Maksimalt 7 dage efter planlagte Dag 1-dosis i næste cyklus.
English: Paclitaxel may cause serious birth defects and should therefore not be used if you are pregnant.
Danish: Paclitaxel kan medføre alvorlige misdannelser, og du bør derfor ikke bruge det, hvis du er gravid.
English: • medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic), and including medicines for treating fungal infections (e.g. ketoconazole)
Danish: • medicin til behandling af infektioner (dvs. antibiotika som erythromycin, rifampicin osv. Spørg din læge, sundhedspersonalet eller apotekspersonalet, hvis du ikke er sikker på, om den medicin, du tager, er et antibiotikum), herunder også medicin til behandling af svampeinfektioner (f.eks. ketoconazol)
English: The non-inferiority criterion was met for both PFS and OS with the upper bound of the 95% confidence interval for the associated hazard ratios being less than 1.176 (Table 13).
Danish: Non-inferioritetskriteriet blev opfyldt for både PFS og OS med den øvre grænse af 95% konfidensintervallet for de tilhørende hazard ratioer på under 1,176 (Tabel 13).
English: The reconstituted dispersion has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Danish: Den rekonstituerede dispersion har en pH-værdi på 6-7,5 og en osmolalitet på 300-360 mOsm/kg.
English: Pazenir should not be used in combination with other anticancer agents.
Danish: Pazenir bør ikke anvendes sammen med andre kræftlægemidler.
English: Patients received a median of 6 cycles of treatment in both study arms.
Danish: Det mediane antal behandlingscyklusser var 6 i begge studiearme.
English: The primary efficacy endpoint was overall survival (OS).
Danish: Det primære virkningsendepunkt var samlet overlevelse (overall survival, OS).
English: • Increased bilirubin in the blood
Danish: • Forhøjet bilirubin i blodet
English: Patients weighing 50 kg had paclitaxel AUC approximately 25% lower than those weighing 75 kg.
Danish: Patienter, der vejer 50 kg havde en paclitaxel-AUC, der var ca. 25% lavere end for patienter, der vejede 75 kg.
English: Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients.
Danish: Neutropeni var den hyppigste vigtige hæmatologiske toksicitet (rapporteret hos 79% af patienterne), den var hurtigt reversibel og dosisafhængig; leukopeni blev rapporteret hos 71% af patienterne.
English: Nadir ANC <500/mm3 with neutropenic fever > 38°C
Danish: Nadir-ANC < 500/mm3 med neutropenisk feber > 38 °C
English: • Weakness and tiredness, fever
Danish: • Svaghed og træthed, feber
English: Cycles were administered at 3 week intervals.
Danish: Behandlingsserierne blev givet med 3 ugers intervaller.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. det er i det væsentlige natrium-frit.
English: It is hypothesised that this enhanced transendothelial caveolar transport is mediated by the gp-60 albumin receptor, and that there is enhanced accumulation of paclitaxel in the area of tumour due to the albumin-binding protein Secreted Protein Acidic Rich in Cysteine (SPARC).
Danish: Der er fremsat hypotese om, at denne øgede transendoteliale caveolae-transport formidles af gp-60 albuminreceptoren, og at der er øget akkumulering af paclitaxel i tumorområdet på grund af det albuminbindende protein Secreted Protein Acidic Rich in Cysteine (SPARC).
English: • a medicine called clopidogrel used to prevent blood clots
Danish: • et lægemiddel, der kaldes clopidogrel og anvendes til at forebygge blodpropper.
English: Based on population pharmacokinetic analysis, the total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel.
Danish: Baseret på en populationsfarmakokinetisk analyse er det totale fordelingsvolumen ca. 1.741 l. Det store fordelingsvolumen indikerer omfattende ekstravaskulær fordeling og/eller vævsbinding af paclitaxel.
English: Use of a 15 µm filter removes strands and does not change the physical or chemical properties of the reconstituted product.
Danish: Trådene fjernes med et 15 µm filter, og de fysiske eller kemiske egenskaber af det rekonstituerede præparat ændres ikke herved.
English: Pazenir Dose
Danish: Pazenir dosis
English: For the other subscale (oedema), there was no difference in the treatment arms.
Danish: For den sidste delskala (ødem) var der ingen forskel i behandlingsarmene.
English: The median time to improvement by at least 1 grade was 21 days, and the median time to improvement from Grade 3 peripheral neuropathy to Grade 0 or 1 was 29 days.
Danish: Mediantiden til forbedring med mindst 1 grad var 21 dage, og mediantiden til forbedring fra grad 3 perifer neuropati til grad 0 eller 1 var 29 dage.
English: Patients with high cardiovascular risk, history of peripheral artery disease and/or of connective tissue disorders and/or interstitial lung disease were excluded from the study.
Danish: Patienter med en høj kardiovaskular risiko eller en anamnese med perifer arteriesygdom og/eller bindevævssygdom og/eller interstitiel lungesygdom blev ekskluderet fra studiet.
English: For treatment of metastatic breast cancer, Pazenir is usually given once every three weeks (on day 1 of a 21-day cycle).
Danish: Til behandling af metastatisk brystkræft gives Pazenir sædvanligvis én gang hver tredje uge (på dag 1 i en 21-dages cyklus).
English: Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Danish: Paclitaxel er et antimikrotubulusstof, der fremmer samlingen af mikrotubulus fra tubulindimerer og stabiliserer mikrotubulus ved at forhindre depolymerisering.
English: 16% had a Karnofsky Performance Status of 100; 42% had a KPS of 90; 35% had a KPS of 80; 7% had a KPS of 70; and <1% of patients had a KPS of below 70.
Danish: 16 % havde en Karnofsky Performance Status (KPS) på 100, 42 % havde en KPS på 90, 35 % havde en KPS på 80, 7 % havde en KPS på 70 og <1 % af patienterne havde en KPS på under 70.
English: Paclitaxel is suspected to cause serious birth defects when administered during pregnancy.
Danish: Paclitaxel er under mistanke for at medføre alvorlige medfødte misdannelser, når det anvendes under graviditeten.
English: Monitor patients closely for signs and symptoms of pneumonitis.
Danish: Overvåg patienterne nøje for tegn og symptomer på pneumonitis.
English: If precipitates or settling are visible, the vial should be gently inverted again to ensure complete redispersion prior to use.
Danish: Hvis der er synligt bundfald eller bundfældning, skal hætteglasset forsigtigt vendes på hovedet igen for at sikre fuldstændig redispersion før brug.
English: Pharmacokinetic data are insufficient for patients with severe renal impairment and not available for patients with end stage kidney disease.
Danish: Farmakokinetiske data er utilstrækkelige for patienter med svært nedsat nyrefunktion, og de er ikke tilgængelige for patienter med nyresygdom i slutstadiet.
English: Pazenir should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
Danish: Pazenir bør ikke anvendes under graviditeten eller til kvinder i den fertile alder, som ikke anvender sikker kontraception, medmindre moderens kliniske tilstand kræver behandling med paclitaxel.
English: After first reconstitution the dispersion should be used immediately.
Danish: Efter den første rekonstitution bør dispersionen anvendes med det samme.
English: Overall Response Rate (independent review)
Danish: Samlet responsrate (uafhængig gennemgang)
English: Paclitaxel may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery.
Danish: Paclitaxel kan muligvis forårsage bivirkninger såsom træthed (meget almindeligt) og svimmelhed (almindeligt), der kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Do not administer the reconstituted dispersion if particulate matter is observed in the vial.
Danish: Administrer ikke den rekonstituerede dispersion, hvis der ses partikler i hætteglasset.
English: Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD01
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, plantealkaloider og andre naturprodukter, taxaner, ATC-kode: L01CD01
English: Following intravenous administration of radiolabelled paclitaxel to rats on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations.
Danish: Efter intravenøs administration af radioaktivt mærket paclitaxel til rotter på dag 9 til 10 postpartum, var koncentrationen af radioaktivitet i mælk højere end i plasma og faldt i takt med plasmakoncentrationen.
English: If patients experience nausea, vomiting and diarrhoea following the administration of Pazenir, they may be treated with commonly used anti-emetics and constipating agents.
Danish: Hvis patienterne oplever kvalme, opkastning og diarré efter administration af Pazenir, kan de behandles med de almindeligt anvendte antiemetika og obstiperende midler.
English: Paclitaxel and/or its metabolites were excreted into the milk of lactating rats.
Danish: Paclitaxel og/eller dets metabolitter blev udskilt i mælken hos diegivende rotter.
English: The primary efficacy endpoint was overall response rate defined as the percentage of patients who achieved an objective confirmed complete response or partial response based on an independent, central, blinded radiological review using RECIST (Version 1.0).
Danish: Det primære virkningsendepunkt var samlet responsrate, defineret som den procentdel patienter, som opnåede et objektivt bekræftet fuldstændigt respons eller et partielt respons, baseret på en uafhængig, central, blindet radiologisk gennemgang ved at bruge retningslinjer fra RECIST (version 1.0).
English: Once the addition is complete, the vial should be allowed to stand for a minimum of 5 minutes to ensure proper wetting of the solid.
Danish: Når tilsætningen er fuldført, skal hætteglasset have lov til at stå i mindst 5 minutter for at sikre ordentlig gennemvædning af det faste stof.
English: Solvent-based paclitaxel (175 mg/m2)
Danish: Solvensbaseret paclitaxel (175 mg/m2)
English: The key secondary endpoints were progression- free survival (PFS) and overall response rate (ORR), both assessed by independent, central, blinded radiological review using RECIST guidelines (Version 1.0).
Danish: De vigtigste sekundære endepunkter var progressionsfri overlevelse (progression-free survival, PFS) og samlet responsrate (overall response rate, ORR), begge vurderet ved en uafhængig, central, blindet radiologisk gennemgang ved at bruge retningslinjer fra RECIST (version 1.0).
English: Very rare: Stevens-Johnson syndrome2, toxic epidermal necrolysis2
Danish: Meget sjælden: Stevens-Johnsons syndrom2, toksisk epidermal nekrolyse2
English: Paclitaxel and gemcitabine do not share a common metabolic pathway.
Danish: Paclitaxel og gemcitabin har ikke fælles metaboliseringsvej.
English: 1On Day 1 of the 21-day cycle reduce the dose of Pazenir and carboplatin simultaneously.
Danish: 1På Dag 1 i 21-dages cyklussen reduceres dosis af Pazenir og carboplatin på samme tid.
English: There was no evidence for accumulation of paclitaxel with multiple treatment courses.
Danish: Der var ikke evidens for akkumulering af paclitaxel ved flere behandlingsforløb.
English: In the comparator treatment arm, gemcitabine monotherapy was administered to patients (N = 430) in accordance with the recommended dose and regimen.
Danish: I den sammenlignende behandlingsarm blev gemcitabin monoterapi administreret til patienter (N = 430) i henhold til den anbefalede dosis og det anbefalede regime.
English: Following recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m2.
Danish: Hvis svær neutropeni eller svær sensorisk neuropati alligevel forekommer, bør der foretages yderligere dosisreduktion til 180 mg/m2.
English: • Effect on peripheral nerves (pain, numbness, tingling or loss of feeling)
Danish: • Virkning på perifere nerver (smerter, følelsesløshed, prikkende fornemmelse)
English: • Changes in heart rate or rhythm, heart failure
Danish: • Ændringer i hjertefrekvens eller -rytme, hjerteinsufficiens