FrancophonIA/ELRC3.0 huggingface dataset:
English: The reduced dose may be escalated to the dose for patients with normal hepatic function if the patient is tolerating the treatment for at least two cycles (see sections 4.4 and 5.2).
Danish: Den reducerede dosis kan øges trinvist til den anvendte dosis hos patienter med normal leverfunktion, hvis patienten tolererer behandlingen i mindst to cyklusser (se pkt.
English: The second trial utilised a dose of 300 mg/m2 as a 30 minute infusion in 63 patients with metastatic breast cancer.
Danish: Det andet studie anvendte en dosis på 300 mg/m2 som en 30 minutters infusion hos 63 patienter med metastaserende brystkræft.
English: Do not breast feed when taking Pazenir as it is not known if the active ingredient paclitaxel passes into the mother's milk.
Danish: Du må ikke amme, mens du tager Pazenir, da det er ukendt, om det aktive stof paclitaxel udskilles i mælken.
English: Proportion of Survival
Danish: Andel overlevende
English: Fifty-nine percent received study medicinal product as second or greater than second-line therapy.
Danish: 59% fik studiemedicinen som anden linje behandling eller senere behandling.
English: Limiting the infusion of Pazenir to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.
Danish: Hvis infusionstiden af Pazenir følger anvisningerne og begrænses til 30 minutter, reduceres risikoen for infusionsrelaterede reaktioner.
English: • Albumin is the part of the medicine that helps paclitaxel dissolve in the blood and get across the walls of the blood vessels into the tumour.
Danish: • Albumin er den del af lægemidlet, der hjælper paclitaxel med at blive opløst i blodet og med at krydse blodkarrenes vægge og nå ind i tumoren.
English: • if you have poor kidney function;
Danish: • hvis du har dårlig nyrefunktion
English: No additional dosage reductions, other than those for all patients, are recommended for patients 65 years and older.
Danish: For patienter 65 år og ældre anbefales ingen yderligere doseringsreduktioner end dem, der gælder for alle patienter.
English: If this happens to you, do not drive or use any tools or machines.
Danish: Du må ikke køre bil eller betjene værktøj eller maskiner, hvis dette sker for dig.
English: However, based on the published literature, paclitaxel is a potentially carcinogenic and genotoxic agent at clinical doses, based upon its pharmacodynamic mechanism of action.
Danish: Paclitaxel er imidlertid - baseret på den offentliggjorte litteratur - et potentielt karcinogent og genotoksisk middel i kliniske doser, baseret på den farmakodynamiske virkningsmekanisme.
English: Paclitaxel belongs to a group of medicines called “taxanes” used in cancer.
Danish: Paclitaxel hører til en gruppe lægemidler, der kaldes ”taxaner”, og anvendes til at behandle kræft.
English: The symptoms were usually transient, typically occurred three days after human serum albumin-paclitaxel nanoparticles administration and resolved within a week.
Danish: Symptomerne var sædvanligvis forbigående, de opstod typisk tre dage efter administration af nanopartikler bestående af humant serumalbumin-paclitaxel og forsvandt inden for en uge.
English: The median time to disease progression was 5.3 months (175 mg/m2; 95% CI: 4.6-6.2 months) and 6.1 months (300 mg/m2; 95% CI: 4.2-9.8 months).
Danish: Den mediane tid til sygdomsprogression var 5,3 måneder (175 mg/m2; 95% CI: 4,6 - 6,2 måneder) og 6,1 måneder (300 mg/m2; 95% CI: 4,2 - 9,8 måneder).
English: Your doctor will arrange a pregnancy test before starting treatment with Pazenir.
Danish: Din læge vil sørge for, at du får en graviditetstest, inden du starter på behandlingen med Pazenir.
English: If not used immediately, the dispersion may be stored in a refrigerator (2°C-8°C) for up to 24 hours in the vial when kept in the outer carton in order to protect it from light.
Danish: Hvis ikke den anvendes med det samme, kan dispersionen opbevares i et køleskab (ved temperaturer på 2 °C-8 °C) i op til 24 timer i hætteglasset, hvis den opbevares i den ydre karton for at beskytte mod lys.
English: The solution should not be injected directly onto the powder as this will result in foaming.
Danish: Infusionsvæsken bør ikke sprøjtes direkte på pulveret, da dette kan resultere i skumdannelse.
English: Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases.
Danish: 64% af patienterne havde nedsat performance-status (ECOG 1 eller 2) ved indgang i studiet; 79% havde viscerale metastaser; og 76% havde > 3 metastaselokalisationer.
English: Closely monitor all patients for signs and symptoms of pneumonitis.
Danish: Alle patienterne skal overvåges nøje for tegn og symptomer på pneumonitis.
English: Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Danish: Pazenir i kombination med carboplatin er indiceret til førstelinjebehandling af ikke-småcellet lungecancer hos voksne patienter, der ikke er kandidater til potentielt kurativ kirurgi og/eller strålebehandling.
English: • A condition involving destruction of red blood cells and acute kidney failure
Danish: • En sygdom, der omfatter ødelæggelse af røde blodlegemer og akut nyresvigt
English: • Deficiency of red blood cells
Danish: • Mangel på røde blodlegemer
English: Pazenir contains sodium
Danish: Pazenir indeholder natrium
English: The response rates in all patients were 39.5% (95% CI: 24.9%54.2%) and 47.6% (95% CI: 35.3%-60.0%), respectively.
Danish: Responsraterne hos alle patienter var henholdsvis 39,5% (95% CI: 24,9% - 54,2%) og 47,6% (95% Cl: 35,3% - 60,0%).
English: The generation of foam must be avoided.
Danish: Dannelse af skum skal undgås.
English: Of the patients with treatment interrupted due to peripheral neuropathy, 44% (31/70 patients) were able to resume human serum albumin-paclitaxel nanoparticlesat a reduced dose.
Danish: Ud af de patienter, der fik behandlingen afbrudt på grund af perifer neuropati, var 44% (31/70 patienter) i stand til at genoptage nanopartikler bestående af humant serumalbumin-paclitaxel med en reduceret dosis.
English: • Pazenir is used in non-small cell lung cancer where surgery or radiotherapy would not be suitable to treat the disease.
Danish: • Pazenir anvendes til ikke-småcellet lungekræft, hvis operation eller strålebehandling ikke er egnet til at behandle sygdommen.
English: • Pazenir is also used together with a medicine called carboplatin if you have the most common type of lung cancer, called “non-small cell lung cancer”.
Danish: • Pazenir anvendes sammen med et lægemiddel, der kaldes carboplatin, hvis du har den mest almindelige type lungekræft, der kaldes ”ikke-småcellet lungekræft”.
English: The generation of foam should be avoided.
Danish: Dannelse af skum bør undgås.
English: MedDRA = Medical Dictionary for Regulatory Activities: SMQ = Standardized MedDRA Query 1 Based on laboratory assessments: maximal degree of myelosuppression (treated population) 2 Peripheral neuropathy is evaluated using the SMQ neuropathy (broad scope) 3 Pneumonitis is evaluated using the SMQ interstitial lung disease (broad scope)
Danish: MedDRA = Medical Dictionary for Regulatory Activities: SMQ = Standardized MedDRA Query 1 Baseret på laboratorievurderinger: Maksimal myelosuppressionsgrad (behandlet population) 2 Perifer neuropati evalueret ved brug af SMQ neuropati (bredt defineret) 3 Pneumonitis evalueret ved brug af SMQ interstitiel lungesygdom (bredt defineret)
English: Talk to your doctor or nurse before using Pazenir
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger Pazenir
English: SMQ = Standardized MedDRA Query; SMQ is a grouping of several MedDRA preferred terms to capture a medical concept.
Danish: SMQ = Standardized MedDRA Query; SMQ er en gruppering af flere foretrukne MedDRA-termer inden for et medicinsk begreb.
English: Paclitaxel has been shown to be genotoxic in vivo (micronucleus test in mice), but it did not induce mutagenicity in the Ames test or the Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT) gene mutation assay.
Danish: Paclitaxel har vist sig at være genotoksisk in vivo (mikronucleustest hos mus), men inducerede ikke mutagenicitet ved Ames-test eller ved kinesisk hamster ovarie/hypoxanthin-guaninfosforibosyltransferase (CHO/HGPRT) genmutationsbestemmelse.
English: When counts recover, resume dosing the following week according to the criteria in Table 4.
Danish: Når tallene er forbedret, skal doseringen genoptages den følgende uge i henhold til kriterierne i Tabel 4.
English: Although limited data is available, no clear benefit in terms of prolonged overall survival has been demonstrated in pancreatic adenocarcinoma patients with normal CA 19-9 levels prior to start of treatment with Pazenir and gemcitabine (see section 5.1).
Danish: Selvom data er begrænsede, er der ikke påvist nogen tydelig fordel med hensyn til langvarig samlet overlevelse hos patienter med adenokarcinom i pancreas med normale CA-19-9-niveauer før behandling med Pazenir og gemcitabin (se pkt.
English: Because of potential serious adverse reactions in breast-feeding infants, Pazenir is contraindicated during lactation.
Danish: På grund af potentielle, alvorlige bivirkninger hos ammede spædbørn er Pazenir kontraindiceret under amning.
English: In addition, paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Danish: Derudover inducerer paclitaxel dannelse af abnorme rækker eller “bundter” af mikrotubuli igennem hele cellecyklus og multiple ”stråler” af mikrotubuli ved centrosomet under mitosen.
English: Albumin (human) Sodium caprylate N-acetyl-DL-tryptophan Sodium chloride Hydrochloric acid Sodium hydroxide
Danish: Albumin (humant) Natriumcaprylat D/L-N-acetyl-tryptophan Natriumchlorid Hydrochloridsyre Natriumhydroxid
English: Complications due to the underlying pancreatic cancer, especially biliary obstruction or presence of biliary stent, were identified as significant contributing factors.
Danish: Komplikationer, der skyldes den underliggende pancreascancer, især galdevejsobstruktion eller tilstedeværelse af galdevejsstent, blev identificeret som signifikante bidragende faktorer.
English: Paclitaxel has been shown to be clastogenic in vitro (chromosome aberrations in human lymphocytes) and in vivo (micronucleus test in mice).
Danish: Paclitaxel har vist sig at være clastogent in vitro (kromosomafvigelser i humane lymfocytter) og in vivo (mikronucleustest hos mus).
English: • People with metastatic breast cancer who received paclitaxel attached to the human protein albumin where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.
Danish: • Personer med metastatisk brystkræft, der fik paclitaxel bundet til det humane protein albumin, efter en anden behandlingsmetode ikke havde hjulpet, havde større sandsynlighed for at opleve en reduktion i tumorstørrelse og levede længere end personer, der fik en anden behandling.
English: General disorders and administration site conditions Asthenia/Fatigue was reported in 40% of the patients.
Danish: Almene symptomer og reaktioner på administrationsstedet Asteni/træthed blev rapporteret af 40% af patienterne.
English: Pazenir will be given to you by a doctor or nurse into a vein from an intravenous drip.
Danish: En læge eller en sygeplejerske vil give dig Pazenir i en vene fra et intravenøst drop.
English: The exact total dosing volume of 5 mg/ml dispersion required for the patient should be calculated and the appropriate amount of reconstituted Pazenir should be injected into an empty, sterile, PVC or non-PVC type intravenous bag.
Danish: Det nøjagtige, totale volumen af 5 mg/ml dispersionen, der kræves til patienten, beregnes, og den korrekte mængde rekonstitueret Pazenir injiceres i en tom, steril (PVC- eller ikke-PVC-type) infusionspose.
English: Common: Sepsis, pneumonia, oral candidiasis
Danish: Almindelig: Sepsis, pneumoni, oral candidiasis
English: For patients with normal baseline CA 19-9 levels the survival HR was 1.07 (95% CI 0.692, 1.661).
Danish: Hos patienter med normale CA-19-9 -niveauer ved baseline var HR for overlevelse 1,07 (95% CI 0,692; 1,661).
English: Pharmacokinetic/pharmacodynamic modeling indicates that there is no correlation between hepatic function (as indicated by the baseline albumin or total bilirubin level) and neutropenia after adjusting for human serum albumin-paclitaxel nanoparticles exposure.
Danish: Farmakokinetiske/farmakodynamiske modeller indikerer, at der ikke er nogen korrelation mellem leverfunktion (indikeret ved niveauet af baseline-albumin eller total bilirubin) og neutropeni efter justering for eksponering for nanopartikler bestående af humant serumalbumin-paclitaxel.
English: Non-small cell lung cancer The recommended dose of Pazenir is 100 mg/m2 administered as an intravenous infusion over
Danish: Ikke-småcellet lungecancer: Den anbefalede dosis af Pazenir er 100 mg/m2 administreret som intravenøs infusion i løbet af
English: • Small bleedings in your skin due to blood clots
Danish: • Små blødninger i huden på grund af blodpropper
English: Instructions for use, handling and disposal Preparation and administration precautions
Danish: Brugsanvisning, håndtering og bortskaffelse Forholdsregler ved klargøring og administration
English: Table 2: Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma Cycle Day
Danish: Tabel 2: Dosismodifikationer for neutropeni og/eller trombocytopeni ved cyklusstart eller i løbet af en cyklus for patienter med adenokarcinom i pancreas Cyklusdag
English: Gastrointestinal disorders Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Danish: Mave-tarm-kanalen Kvalme forekom hos 29% af patienterne og diarré hos 25% af patienterne.
English: The carcinogenic potential of paclitaxel has not been studied.
Danish: Paclitaxels karcinogenictet er ikke blevet undersøgt.
English: This is because Pazenir can affect the way some other medicines work.
Danish: Det skyldes, at Pazenir kan påvirke virkningen af andre lægemidler, og andre lægemidler kan påvirke virkningen af Pazenir.
English: Blood and lymphatic system disorders1
Danish: Blod og lymfesystem1
English: • Pain in the muscles
Danish: • Smerter i muskler
English: Unopened vials of Pazenir are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Danish: Uåbnede hætteglas med Pazenir er stabile indtil den dato, der er angivet på emballagen, så længe hætteglasset opbevares i den ydre karton for at beskytte mod lys.
English: Contents of the pack and other information What Pazenir contains
Danish: Pakningsstørrelser og yderligere oplysninger Pazenir indeholder:
English: • Skin reaction to another agent or lung inflammation following radiation
Danish: • Hudreaktion over for andre stoffer eller lungebetændelse efter strålebehandling
English: A higher median cumulative dose of gemcitabine was delivered in the human serum albumin-paclitaxel nanoparticles/gemcitabine arm (11400 mg/m2) when compared with the gemcitabine arm (9000 mg/m2).
Danish: En højere median kumulativ dosis af gemcitabin blev givet i nanopartikler bestående af humant serumalbumin-paclitaxel/gemcitabin-armen (11.400 mg/m2) sammenlignet med gemcitabin-armen (9.000 mg/m2).
English: • Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes
Danish: • Nedsat muskelkoordinering eller læsebesvær, øget eller mindre tåreflåd, tab af øjenvipper
English: Day 15: If Day 8 doses were given without modification:
Danish: Dag 15: Hvis Dag 8 doser blev givet uden modifikation:
English: Rare occurrences of severe hypersensitivity reactions, including very rare events of anaphylactic reactions with fatal outcome, have been reported.
Danish: Der er rapporteret om sjældne tilfælde af overfølsomhedsreaktioner, herunder meget sjældne forekomster af anafylaktiske reaktioner med letalt udfald.
English: 1st dose level reduction 2nd dose level reduction If additional dose reduction required
Danish: Fuld dosis 1. reduktion i dosisniveau 2. reduktion i dosisniveau Hvis yderligere dosisreduktioner er nødvendige
English: The fraction of free paclitaxel was significantly higher with human serum albumin-paclitaxel nanoparticles (6.2%) than with solventbased paclitaxel (2.3%).
Danish: Fraktionen af frit paclitaxel var signifikant højere med nanopartikler bestående af humant serumalbumin-paclitaxel (6,2%) end med solvensbaseret paclitaxel (2,3%).
English: For treatment of non-small cell lung cancer Pazenir is given once every week (i.e. on days 1, 8 and 15 of a 21 day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Pazenir dose has been given.
Danish: Til behandling af ikke-småcellet lungekræft gives Pazenir én gang ugentligt (dvs. på dag 1, 8 og 15 i hver 21-dages cyklus), hvor carboplatin gives en gang hver tredje uge (dvs. kun på dag 1 i hver 21-dages cyklus), umiddelbart efter Pazenir-dosis er blevet givet.
English: Frequent monitoring of blood cell counts should be performed during Pazenir therapy.
Danish: Hyppig blodtælling er nødvendig under behandling med Pazenir.
English: Pazenir is a white to yellow powder for dispersion for infusion.
Danish: Pazenir er et hvidt til gult pulver til infusionsvæske, dispersion.
English: Non-haematologic Toxicity
Danish: Ikke-hæmatologisk toksicitet
English: Paclitaxel and/or its metabolites were excreted into the milk of lactating rats (see section 5.3).
Danish: Paclitaxel og/eller dets metabolitter blev udskilt i mælken hos diegivende rotter (se pkt.5.3).
English: Peripheral neuropathy evaluated using the SMQ (broad scope).
Danish: 1 Perifer neuropati evalueret ved brug af SMQ (bredt defineret).
English: This resulted in significantly higher exposure to unbound paclitaxel with human serum albumin-paclitaxel nanoparticles compared with solvent-based paclitaxel, even though the total exposure is comparable.
Danish: Dette medførte signifikant højere eksponering for ubundet paclitaxel med nanopartikler bestående af humant serumalbumin-paclitaxel sammenlignet med solvensbaseret paclitaxel, selvom den totale eksponering er sammenlignelig.
English: • Pazenir is used in metastatic breast cancer when at least one other therapy has been tried but has not worked and you are unsuitable for treatments containing a group of medicines called “anthracyclines”.
Danish: • Pazenir anvendes til metastatisk brystkræft, når mindst en anden behandlingsmetode er blevet forsøgt, men ikke har hjulpet, og behandling med en gruppe lægemidler, der kaldes ”antracykliner”, ikke er egnet til dig.
English: Anemia and thrombocytopenia were more commonly reported in the human serum albumin-paclitaxel nanoparticles arm than in the Taxol arm (54% versus 28% and 45% versus 27% respectively).
Danish: Anæmi og trombocytopeni blev hyppigere reporteret i nanopartikler bestående af humant serumalbumin-paclitaxel-armen end i Taxol-armen (hhv. 54% versus 28% og 45% versus 27%).
English: Pazenir is supplied as a sterile lyophilised powder for reconstitution before use.
Danish: Pazenir leveres som et sterilt, frysetørret pulver til rekonstitution inden brug.
English: Pazenir is an albumin-bound nanoparticle formulation of paclitaxel, which may have substantially different pharmacological properties compared to other formulations of paclitaxel (see sections 5.1 and 5.2).
Danish: Pazenir er en albuminbundet nanopartikelformulering af paclitaxel, som kan have væsentligt forskellige farmakologiske egenskaber sammenlignet med andre formuleringer af paclitaxel (se pkt.
English: Patients with pancreatic adenocarcinoma aged 75 years and older should be carefully assessed before treatment is considered (see section 4.4).
Danish: Patienter med adenokarcinom i pancreas i alderen 75 år og ældre bør vurderes nøje, før behandling overvejes (se pkt.
English: Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6α-hydroxypaclitaxel; and to two minor metabolites, 3'-phydroxypaclitaxel and 6α-3'-p-dihydroxypaclitaxel.
Danish: Baseret på den offentliggjorte litteratur viser in vitro-studier med humane levermikrosomer og vævssnit, at paclitaxel primært bliver metaboliseret til 6α-hydroxypaclitaxel og til to mindre metabolitter, 3'-p-hydroxypaclitaxel og 6α -3'-p-dihydroxypaclitaxel.
English: Efficacy Parameter
Danish: Virkningsparameter
English: Pancreatic adenocarcinoma (Pazenir administered in combination with gemcitabine)
Danish: Adenokarcinom i pancreas (Pazenir administreret i kombination med gemcitabin)
English: Male patients treated with Pazenir are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment.
Danish: Mandlige patienter behandlet med Pazenir anbefales at anvende sikker kontraception samt at undgå at gøre kvinder gravide under og i seks måneder efter behandlingen.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt gruppering af hyppigheder er bivirkningerne angivet efter, hvor alvorlige de er.
English: Pazenir should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Danish: Pazenir bør kun klargøres og administreres af personale, der har modtaget passende træning i håndteringen af cytotoksiske midler.
English: Grade 3 mucositis or diarrhoea
Danish: Grad 3 mukosit eller diarré
English: 4.6 Fertility, pregnancy and breast-feeding
Danish: 4.6 Fertilitet, graviditet og amning
English: For patients of 75 years and older, no benefit for the combination treatment of Pazenir and gemcitabine in comparison to gemcitabine monotherapy has been demonstrated.
Danish: Patienter 75 år og ældre Hos patienter på 75 år og ældre blev der ikke påvist en fordel af kombinationsbehandling med Pazenir og gemcitabin sammenlignet med monoterapi med gemcitabin.
English: Gastrointestinal Toxicity:
Danish: Gastrointestinal toksicitet:
English: What you need to know before you use Pazenir Do not use Pazenir
Danish: Det skal du vide, før du begynder at få Pazenir Brug ikke Pazenir:
English: • if you have severe liver problems;
Danish: • hvis du har svære leverproblemer
English: At the clinical dose range of 80 to 300 mg/m2, the mean plasma clearance of paclitaxel ranges from 13 to 30 L/h/m2, and the mean terminal half-life ranges from 13 to 27 hours.
Danish: Ved det kliniske dosisinterval på 80 til 300 mg/m2 var den gennemsnitlige plasmaclearance af paclitaxel i intervallet fra 13 til 30 l/t/m2, og den gennemsnitlige terminale halveringstid var i intervallet fra 13 til 27 timer.
English: Mild to moderate renal impairment (creatinine clearance ≥30 to <90 ml/min) has no clinically important effect on the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Danish: Let til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 til < 90 ml/min) har ingen klinisk vigtig virkning på paclitaxels maksimale eliminationshastighed og systemiske eksponering (AUC og Cmax).
English: Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • Abnormal decrease in the number of types of white blood cells (neutrophils, lymphocytes or leukocytes) in the blood
Danish: • Unormalt fald i antallet af nogle typer hvide blodlegemer (neutrofiler, lymfocytter eller leukocytter) i blodet
English: Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Pazenir.
Danish: Paclitaxel er et cytotoksisk lægemiddel mod cancer, og som ved andre potentielt toksiske forbindelser, skal der udvises forsigtighed ved håndtering af Pazenir.