FrancophonIA/ELRC3.0 huggingface dataset:
English: Cardiac monitoring is not recommended except in patients with serious conduction abnormalities or arrhythmias.
Danish: Kardiel monitorerring anbefales ikke med undtagelse hos patienter med alvorlige overledningsforstyrrelser eller arytmier.
English: However, the higher response rates (37 % vs. 26 %), lesser overall side effects and improved short term QoL with cisplatin/paclitaxel vs cisplatin/tenoposide were considered important results in a palliative population.
Danish: De højere responsrater (37 % vs 26 %), mindre totale bivirkninger og forbedret korttids livskvalitet med cisplatin/paclitaxel vs cisplatin/tenoposid blev imidlertid betragtet som vigtige resulater i en palliativ population.
English: The results obtained with Paxene are closely similar to those of published paclitaxel Phase III trials.
Danish: De resultater, der blev opnået med Paxene, ligger meget tæt på resultaterne fra offentliggjorte paclitaxel fase III-undersøgelser.
English: You should be able to drive and use machines between your treatments with Paxene, unless you feel tired or dizzy
Danish: Mellem behandlingerne med Paxene skulle du kunne køre bil og betjene maskiner, medmindre du er træt eller svimmel.
English: Thrombocytopenia was observed in 50% of patients, and was severe (< 50,000 cells/mm3) in 9 %.
Danish: Trombocytopeni blev set hos 50 % af patienterne og var alvorlig (<50.000 celler/mm3) hos 9 %.
English: Use by:
Danish: Anvendes inden:
English: The prepared solution may appear hazy.
Danish: Den klargjorte opløsning kan se uklar ud.
English: Clearance was 20.6 l/h/m2 (range 11 - 38) and the volume of distribution was 291 l/m2 (range 121 - 638).
Danish: Clearance var på 20,6 l/t/m2 (variation 11 - 38), og fordelingsvolumen var på 291 l/m2 (variation 121 - 638).
English: Paraesthesia was observed in 48 % of patients.
Danish: Paræstesi blev observeret hos 48 % af patienterne.
English: Bleeding episodes related to Paxene were reported in < 3% of patients and bleeding was localised.
Danish: Blødningsepisoder relateret til Paxene blev rapporteret hos <3 % af patienterne, og blødning var lokal.
English: Uncommon: dry eyes, amblyopia, visual field defect Very rare*: optic nerve and/or visual disturbances (scintillating scotoma), particularly in patients who have received higher doses than recommended
Danish: Ikke almindelig: Øjentørhed, amblyopi, defekt af synsfelt Meget sjældent*: Optiske nerve og/eller visuelle forstyrrelser (scintillerende scotomata), især hos patienter, der har fået højere doser end anbefalet
English: Very rare*: acute encephalopathy, autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension),
Danish: Meget sjælden*: Akut encefalopati, autonom neuropati (resulterende i paralytisk ileus og ortostatisk hypotension),
English: AIDS-related Kaposi's sarcoma
Danish: Aids-relateret Kaposis sarkom
English: • Advanced AIDS-related Kaposi's sarcoma when certain other treatments (liposomal anthracyclines) have been tried but have not worked.
Danish: • avanceret aids-relateret Kaposis sarkom, når visse andre behandlinger (liposomal anthracyclin) har været anvendt uden resultat.
English: In the MBC and MOC studies a total of two patients experienced Grade 4 congestive heart failure.
Danish: I MBC- og MOC-undersøgelserne oplevede i alt to patienter kongestiv hjerteinsufficiens, grad 4.
English: • Changes in your skin and nails
Danish: • Forandringer i hud og negle
English: Anaemia (Hb< 11 g/dl) was observed in approximately 9 % of treated patients but was severe in less than 1 % (Hb< 8 g/dl).
Danish: Anæmi (Hb <11g/dl) konstateredes hos cirka 9 % af de behandlede patienter, men var alvorlig hos mindre end 1 % (Hb <8g/dl).
English: London E16 2QJ United Kingdom
Danish: London E16 2QJ Storbritannien
English: Anaemia (Hb < 11 g/dL) was observed in 61 % of patients and was severe (Hb < 8 g/dL) in 10 %.
Danish: Anæmi (Hb < 11 g/dl) blev set hos 61 % af patienterne og var alvorlig (Hb < 8g/dl) hos 10 %.
English: Pre-existing neuropathies resulting from prior therapies are not a contraindication for paclitaxel therapy.
Danish: Præ-eksisterende neuropatier resulterende fra tidligere behandlinger er ikke en kontraindikation for behandling med paclitaxel.
English: Additionally, in Paxene MBC and MOC studies tachycardia, palpitation and syncope were observed.
Danish: Desuden observeredes der i undersøgelser af Paxene hos patienter med MBC og MOC takykardi, palpitation og synkope.
English: • Before you start treatment with Paxene and during treatment, you will have regular blood tests to check that it is safe for you to continue with your treatment.
Danish: • Før du påbegynder en behandling med Paxene, såvel som under behandlingen, tager man flere blodprøver for at undersøge, om det er sikkert at fortsætte behandlingen.
English: For use of cisplatin in treatment of advanced ovarian carcinoma and non-small cell lung carcinoma, please consult the cisplatin Summary of Product Characteristics for information.
Danish: Vedrørende brug af cisplatin i behandling af fremskreden ovariecarcinom og ikke-småcellet lungecarcinom bør man rådføre sig med produktresuméet for cisplatin for oplysninger.
English: Severe neuropathy and severe paraesthesia occurred in 3 % and 5 % of patients, respectively.
Danish: Alvorlig neuropati og kraftig paræstesi for hos henholdsvis 3 % og 5 % af patienterne.
English: Moderate to severe mucositis is uncommon with the recommended dose and schedule of Paxene.
Danish: Moderate til alvorlige tilfælde af mucositis er ualmindelige ved den anbefalede dosering og dosisintervaller for Paxene.
English: If any problems occur while you are having your infusion, the medical staff will be on hand to take any necessary action.
Danish: Opstår der problemer under infusionen, vil personalet være klar til at træffe de nødvendige forholdsregler.
English: In order to minimise patient exposure to the plasticiser DEHP [di-(2-ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted Paxene solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
Danish: For at udsætte patienten mindst muligt for blødgøringsmidlet DEHP [di-(2-ethylhexyl)phthalate], som kan lække fra PVC-infusionsposer ellersæt, bør fortyndede Paxene-opløsninger opbevares i flasker (glas, polypropylene) eller plastikposer (polypropylene, polyolefin) og gives gennem polyethylen-forede administrationssæt.
English: Very rare*: Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, urticaria, onycholysis (patients on therapy should wear sun protection on hands and
Danish: Meget sjælden*: Steven-Johnson syndrom, epidermal nekrolyse, erythema multiforme, urticaria, onykolyse (patienter i behandling bør bære solbeskyttelse på hænderne og fødderne
English: With respect to progression free survival, highly statistically significant results were noted for the high-dose paclitaxel arm compared with etoposide/cisplatin (p= 0.007).
Danish: Med hensyn til progressionsfri overlevelse blev der set yderst statistisk signifikante resultater for højdosis paclitaxel-armen sammenlignet med etoposid/cisplatin (p=0.007).
English: Appropriate supportive medicinal products should be readily available in case of severe hypersensitivity reactions.
Danish: Passende understøttende lægemidler bør stå klare i tilfælde af kraftige overfølsomhedsreaktioner.
English: Very common: minor hypersensitivity reactions (mainly flushing and rash)
Danish: Meget almindelig: Mindre overfølsomhedsreaktioner (hovedsagelig rødme og udslæt)
English: • Injection site reactions leading to pain, swelling and hardness of the skin around the injection site.
Danish: • Smerter ved injektionsstedet, der fører til smerter, hævelse og hårdhed af huden omkring injektionsstedet.
English: Renal excretion plays a minor role in the elimination of paclitaxel, less than 10 % of the dose has been reported to be excreted in the urine as unchanged drug.
Danish: Udskillelse gennem nyrerne spiller en mindre rolle i den samlede udskillelse af paclitaxel, hvor under 10 % af dosen udskilles som uforandret lægemiddel i urinen.
English: Preparation for intravenous infusion
Danish: Forberedelse til intravenøs infusion
English: • Ringing in your ears
Danish: • Ringen for ørerne
English: Although the two different paclitaxel posologies were not compared with each other directly, in both trials patients treated with paclitaxel in combination with cisplatin had a significantly longer time to progression (Study 1: median 15.3 months vs 11.5 months, p< 0.001; Study 2: median 17 months vs 13 months, p< 0.001), and longer survival time (Study 1: median 36 months vs 26 months, p= 0.0016; Study 2: median 36 months vs 24 months, p< 0.001), and in Study 1 a significantly higher response rate (Study 1: 59 % vs 45 %, p= 0.014; Study 2: 60 % vs 50 %, NS), when compared with standard therapy.
Danish: Selvom de to doseringer af paclitaxel ikke blev sammenlignet direkte med hinanden, havde patienterne i begge afprøvninger behandlet med paclitaxel i kombination med cisplatin en signifikant længere tid til progression (undersøgelse 1: median 15,3 måneder vs 11,5 måneder, p<0.001; undersøgelse 2 median 17 måneder vs 13 måneder, p<0.001) og længere overlevelse (undersøgelse 1: median 36 måneder vs 26 måneder, p=0.0016; undersøgelse 2: median 36 måneder vs 24 måneder, p<0.001) og i undersøgelse 1 en signifikant højere responsrate (undersøgelse 1: 59 % vs 45 %, p=0.014; undersøgelse 2: 60 % vs 50 %, NS) ved sammenligning med standardbehandling.
English: The efficacy and safety of paclitaxel were evaluated in two major, randomised, controlled trials (vs. ciclophosphamide 750 mg/m2/ cisplatin 75 mg/m2).
Danish: Effekt og sikkerhed ved paclitaxel blev evalueret i to større, randomiserede, kontrollerede afprøvninger (vs. Cyklofosfamid 750 mg/m2/cisplatin 75 mg/m2).
English: Consequently, the use of plasticised PVC containers and administration sets is not recommended.
Danish: Derfor kan brug af plastificerede PVC-beholdere og infusionssæt ikke anbefales.
English: Except for haematological and hepatic events (see below), generally the frequency and severity of undesirable effects in AIDS-KS patients were similar to those noted in patients with other solid tumours treated with paclitaxel monotherapy.
Danish: Med undtagelse af hæmatologiske og hepatiske hændelser (se nedenfor) var frekvensen og alvorligheden af bivirkninger hos aids-KSpatienterne almindeligvis magen til dem, der blev set hos patienter med andre faste tumorer behandlet med paclitaxel monoterapi.
English: Levels of the extractable plasticiser DEHP [di-(2-ethylhexyl)phthalate] increase with time and concentration when dilutions are prepared in PVC containers.
Danish: Niveauet af det blødgøringsmiddel DEHP [di-(2-ethylhexyl)ftalat], der kan lække ud, øges med tid og koncentration, når fortynding foretages i en PVC-beholder.
English: Following an infusion of Paxene, the patients' performance at skilled tasks such as driving and operating machines may be impaired due to the alcohol content of Paxene (see section 4.4).
Danish: Efter en infusion af Paxene kan patientens evne til udføre krævende opgaver, såsom at køre bil og betjene maskiner, være nedsat grundet alkoholindholdet i Paxene (se pkt.
English: Two percent of patients had a platelet count nadir < 50,000 cells/mm3.
Danish: To procent af patienterne havde et trombocyttal nadir < 50.000 celler/mm3.
English: Median survival for each paclitaxel-containing arm was not significantly different compared to etoposide/cisplatin (p= 0.097 and 0.090 for high-dose paclitaxel and low-dose paclitaxel, respectively).
Danish: Median overlevelse for hver paclitaxel-indeholdende arm var ikke dignifikant forskellig sammenlignet med etoposid(cisplatin ) p=0.097 og 0.090 for henholdsvis højdosis paclitaxel og lavdosis paclitaxel).
English: Paxene is indicated for the treatment of patients with: - advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy; - metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy; - advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment; - metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment; - non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin.
Danish: Paxene er indikeret til behandling af patienter med: - fremskreden aids-relateret Kaposis sarkom (aids-KS), som det ikke er lykkedes at behandle med forudgående liposomal anthracyclin terapi; - metastatisk brystkarcinom (MBC), som det ikke er lykkedes at behandle, eller som ikke er egnet til behandling med anthracyclinholdig standardterapi: - fremskreden ovariecarcinom (AOC) eller med residualsygdom (> 1 cm) efter initial laparotomi, i kombination med cisplatin som førstevalgsbehandling; - metastatisk ovariekarcinom (MOC), hvor det ikke er lykkedes at behandle med platinholdig kombinationsterapi uden taxaner som andetvalgsbehandling; - Ikke-småcellet lungecarcinom (NSCLC), som ikke er egnet til potentiel kurativ operation og/eller strålebehandling i kombination med cisplatin.
English: Formal clinical drug interaction studies have not been performed with Paxene.
Danish: Der er ikke gennemført formelle undersøgelser af kliniske interaktioner med andre lægemidler og Paxene.
English: No known antidote exists for Paxene overdose.
Danish: Der findes ikke en kendt antidot mod en Paxene-overdosis.
English: Injection site reactions including reactions secondary to extravasation were usually mild and consisted of erythema, tenderness, skin discolouration, or swelling at the injection site but can result in cellulitis.
Danish: Reaktioner på injektionsstedet, herunder sekundære reaktioner på ekstravasation, var generelt milde og bestod af erythema, ømhed, misfarvning af huden eller opsvulmen ved injektionsstedet, men kan medføre cellulitis.
English: Among patients (> 50 % on protease inhibitors) with normal baseline liver function, 28 %, 43 % and 44 % had elevations in bilirubin, alkaline phosphatase and AST (SGOT), respectively.
Danish: Blandt patienterne (>50 % på proteasehæmmere) med normal leverfunktion fra starten, havde 28 %, 43 % og 44 % forhøjelser af henholdsvis bilirubin, alkalisk fosfatase og AST (SGOT).
English: Advanced non-small cell lung cancer
Danish: Fremskreden ikke-småcellet lungekræft
English: Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle.
Danish: Når præparatet er færdigt, kan opløsningen være uklar, hvilket tilskrives formuleringens bindemiddel.
English: If you have a history of heart problems, your heart rate may be monitored.
Danish: Hvis du før har haft hjerteproblemer, vil din puls blive registreret.
English: Recurrence of skin reactions at a site of previous extravasation following administration of paclitaxel at a different site i.e. “recall” has been reported rarely.
Danish: Recidiv af hudreaktioner på et sted med tidligere ekstravasation efter administration af paclitaxel på et andet sted er blevet rapporteret i sjældne tilfælde.
English: In NSCLC and ovarian cancer patients treated with paclitaxel over 3 hours followed by cisplatin, there is an apparent increase in the incidence of severe neurotoxicity.
Danish: Hos patienter med NSCLC og ovariekræft, der blev behandlet med paclitaxel over 3 timer efterfulgt af cisplatin, er der en tydelig øgning i incidensen af alvorlig neurotoksicitet.
English: Discard any unused contents according to standard practice for cytotoxic agents.
Danish: Bortkast ubrugt indhold i overensstemmelse med gængse fremgangsmåder for cytotoksiske stoffer.
English: The table below lists undesirable effects associated with the administration of single agent paclitaxel as a 3 hour infusion in the metastatic setting (286 patients treated in Paxene clinical studies and 812 patients treated in other paclitaxel clinical studies), and those reported in the postmarketing surveillance of paclitaxel*.
Danish: Tabellen nedenfor angiver bivirkninger forbundet med administrationen af enkeltmiddel paclitaxel som en 3 timers infusion under metastatiske forhold (286 patienter behandlet i kliniske undersøgelser af Paxene, og 812 patienter behandlet i andre paclitaxel kliniske undersøgelser) og dem, der blev rapporteret i den postmarkedsføringsmæssige overvågning af paclitaxel*.
English: Very rare*: atrial fibrillation
Danish: Meget sjælden*: Atriefibrillering
English: • Severe infections such as pneumonia
Danish: • Alvorlige infektioner såsom lungebetændelse
English: Male patients treated with Paxene are advised not to father a child during and up to six months after the treatment.
Danish: Det frarådes mandlige patienter, der behandles med Paxene, at få børn under og op til 6 måneder efter behandlingen.
English: Bone marrow suppression was the major dose-limiting toxicity of Paxene.
Danish: Knoglemarvssuppression var den hovedsagelige dosisbegrænsende toksicitet ved Paxene.
English: Grade 2 or 3 peripheral neurotoxicity was observed more commonly with cisplatin/paclitaxel (29 % vs. 6 %).
Danish: Grad 2 eller 3 perifer neurotoksicitet blev set mere almindeligt med cisplatin/paclitaxel (29 % vs 6 %).
English: Very rare*: confusional state
Danish: Meget sjælden: Tilstand af forvirring
English: Severe peripheral neuropathy occurred in 3 % of patients treated with the recommended dose and schedule of Paxene.
Danish: Kraftig perifer neuropati forekom hos 3 % af patienterne, der blev behandlet med den anbefalede dosis og regime af Paxene.
English: • Lack of sleep
Danish: • Søvnmangel
English: • Mild allergic reactions including flushing and skin rash
Danish: • Milde allergiske reaktioner inklusive rødme og hududslæt
English: Neuropathy occurred in 18 % of patients treated with Paxene.
Danish: Neuropati forekom hos 18 % af patienterne behandlet med Paxene.
English: • Dehydration, weight loss or weight gain
Danish: • Dehydrering, vægttab eller vægtforøgelse
English: Since paclitaxel is metabolised by cytochrome P450 isoenzymes CYP 3A4 and 2C8, caution should be exercised with other medicinal products known to inhibit (e.g. erythromycin, fluoxetine, gemfibrozil, imidazole antifungals) or induce (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine) these enzymes as they may affect the pharmacokinetics of paclitaxel.
Danish: Da paclitaxel metaboliseres af cytochrome P450 isoenzymerne CYP 3A4 og 2C8, bør andre lægemidler, der hæmmer (f.eks. erythromycin, fluoxetin, gemfibrozil, imidazol svampedræbende midler) eller inducerer (f.eks. rifampicin, carbamazepin, phenytoin, fenobarbital, efavirenz, nevirapin) disse enzymer, anvendes med forsigtighed, da de eventuelt kan påvirke paclitaxels farmakokinetik.
English: Studies conducted in AIDS-KS patients who were taking Paxene and multiple concomitant medicinal products suggest that the systemic clearance of paclitaxel was significantly lower (p < 0.05) in the presence of nelfinavir and ritonavir, but not with indinavir.
Danish: Undersøgelser af aids-KS patienter, der tog Paxene og andre lægemidler samtidigt, viser, at den systemiske clearance af paclitaxel var betydeligt lavere (p < 0,05) i tilfælde, hvor der blev givet nelfinavir og ritonavir, men ikke i kombination med indinavir.
English: • Advanced breast cancer when certain other treatments (standard anthracycline-containing therapy) have been tried but have not worked or when the patient is unsuitable for these treatments.
Danish: • avanceret brystkræft, når visse andre behandlinger (anthracyclinholdig standardterapi) har været anvendt uden resultat, eller hvis patienten er uegnet til disse behandlinger.
English: The major elimination pathway is metabolism followed by biliary excretion; in six patients 39 % to 87 % of an intravenous dose (175 mg/m2) was excreted in faeces and, on average, only 10 % of the dose was excreted as unchanged paclitaxel.
Danish: Den største udskillelsesvej er metabolisme efterfulgt af udskillelse via galden; hos seks patienter blev 39 % til 87 % af en intravenøs dosis (175 mg/m²) udskilt i fæces, og i gennemsnit blev kun 10 % af dosen udskilt som uforandret paclitaxel.
English: • Infections such as pneumonia
Danish: • Infektioner såsom lungebetændelse
English: Intravenous use
Danish: Til intravenøs brug
English: As Paxene contains ethanol (392 mg/ml), possible effects on the CNS and other effects should be considered (see section 4.7).
Danish: Da Paxene indeholder ethanol (392 mg/ml) bør mulige virkninger på centralnervesystemet og andre virkninger tages i betragtning (se pkt.
English: • High blood pressure, blood clots and inflammation in the veins
Danish: • Højt blodtryk, blodpropper og betændelse i årerne
English: Rare*: anaphylactic reactions
Danish: Sjælden*: Anafylaktiske reaktioner
English: In eight published clinical trials (8 Phase III trials) including 4,735 patients with advanced ovarian cancer and in twelve published clinical trials (one large Phase II and eleven Phase III trials) including 4,315 NSCLC patients treated with paclitaxel and platinum-containing regimens, similar undesirable effects were observed compared to single-agent paclitaxel treatment.
Danish: I otte offentliggjorte kliniske undersøgelser (8 fase III afprøvninger) omfattende 4735 patienter med fremskreden ovariekræft og i tolv offentliggjorte kliniske afprøvninger (én stor fase II og elve fase III afprøvninger) omfattende 4315 NSCLC patienter behandlet med paclitaxel og platin-indeholdende regimer, blev der observeret lignende bivirkninger sammenlignet med enkeltmiddelpaclitaxelbehandling.
English: If you are already being treated with doxorubicin for your condition, then your first dose of paclitaxel should be given 24 hours after doxorubicin.
Danish: Hvis du allerede er i behandling med doxorubicin mod brystkræft, og din læge yderligere vil give dig paclitaxel, så bør din første dosis paclitaxel gives 24 timer efter doxorubicin.
English: • Severe allergic reactions (anaphylactic reaction) - you may experience localised itching and swelling of the hands, feet, ankles, face.
Danish: • Alvorlige allergiske reaktioner (anafylaktisk reaktion) - du kan opleve lokal kløe og hævelser af hænder, fødder, ankler, ansigt, læber, mund, tunge eller hals
English: Clear, colourless to slightly yellow, viscous solution.
Danish: Klar, farveløs til svag gullig, viskøs opløsning.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke bruges straks, er opbevaringstid og -betingelser før brug brugerens eget ansvar og bør normalt ikke overskride 24 timer ved 2 til 8 °C, medmindre fortyndingen er blevet foretaget under kontrollerede og anerkendte aseptiske forhold.
English: Sensory symptoms have usually improved or resolved within months of paclitaxel discontinuation.
Danish: Sensoriske symptomer bedres eller forsvinder sædvanligvis indenfor måneder efter seponering afpaclitaxel.
English: Handling and disposa Procedures for proper handling and disposal of cytotoxic medicinal products should be followed.
Danish: Håndtering og bortskaffelse Procedurerne for rigtig håndtering og bortskaffelse af cytotoksiske lægemidler bør følges.
English: When given as a longer infusion, increased myelosuppression may be seen in patients with moderate to severe hepatic impairment.
Danish: Ved indgivelse som længerevarende infusion kan der forekomme øget myelosuppression hos patienter med moderat til svært nedsat leverfunktion.
English: Severe neutropenia (< 500 cells/mm3) occurred in 20 % and 39% of patients during the first course of treatment and the entire treatment period, respectively.
Danish: Kraftig neutropeni (<500 celler/mm3) forekom hos henholdsvis 20 % og 39 % af patienterne under det første behandlingsforløb og hele behandlingsperioden.