FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of cabazitaxel, thus facilities and equipment for the treatment of hypotension and bronchospasm should be available.
Danish: Overfølsomhedsreaktioner kan forekomme inden for nogle få minutter efter, at infusionen af cabazitaxel er påbegyndt, så faciliteter og udstyr til behandling af hypotension og bronkospasme bør være tilgængelige.
English: Patients should be advised not to drive or use machines if they experience these adverse reactions during treatment.
Danish: Patienter rådes til ikke at føre motorkøretøj eller betjene maskiner, hvis de oplever disse bivirkninger under behandlingen.
English: • Concomitant vaccination with yellow fever vaccine (see section 4.5).
Danish: • Samtidig vaccination med vaccine mod gul feber (se pkt.
English: As with all parenteral products, the resulting infusion solution should be visually inspected prior to use.
Danish: Som alle parenterale produkter skal den færdigblandede infusionsvæske undersøges visuelt inden brug.
English: There was no statistical difference between both treatment arms in pain progression and pain response.
Danish: Der var ingen statistisk signifikant forskel på begge behandlingsarme vedrørende smerte og smerte progression.
English: The use of G-CSF has been shown to limit the incidence and severity of neutropenia.
Danish: Brugen af G-CSF er blevet påvist at begrænse forekomsten og sværhedsgraden af neutropeni.
English: • you have severe or long-lasting diarrhoea, you feel sick (nausea) or you are being sick (vomiting).
Danish: • du har alvorlig eller langvarig diarré, du føler dig syg (kvalme), eller du er syg (opkastning).
English: Harmful for those suffering from alcoholism.
Danish: Skadelig for alkoholikere.
English: Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents may result in serious or fatal infections.
Danish: Administration af levende, eller levende svækkede vacciner hos patienter, der er immunkompromitteret af kemoterapeutiske midler, kan resultere i alvorlige eller dødelige infektioner.
English: He/she may give you other medicines to maintain the number of your blood cells.
Danish: Lægen vil eventuelt give dig anden medicin for at opretholde antallet af blodlegemer.
English: Before each treatment with JEVTANA, you will have blood tests to check that you have enough blood cells and sufficient liver and kidney functions to receive JEVTANA.
Danish: Inden den enkelte behandling med JEVTANA, vil der blive taget blodprøver for at sikre, at du har nok blodlegemer og tilstrækkelig lever- og nyrefunktion til at modtage JEVTANA.
English: You are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because JEVTANA may alter male fertility.
Danish: Det tilrådes, at du ikke gør en kvinde gravid under og op til 6 måneder efter behandlingen, og at du søger råd om opbevaring af sæd inden behandlingen, fordi JEVTANA kan påvirke mænds frugtbarhed.
English: Appropriate measures should be taken to re-hydrate patients.
Danish: Der skal træffes foranstaltninger for at rehydrere patienterne.
English: Caution is recommended in patients with haemoglobin <10 g/dl and appropriate measures should be taken as clinically indicated.
Danish: Der anbefales forsigtighed hos patienter med hæmoglobin <10 g/dl, og der bør tages passende forholdsregler efter den kliniske indikation.
English: Risk of serious gastrointestinal reactions
Danish: Risiko for alvorlige gastrointestinale bivirkninger
English: This can occur if you have a hole in the stomach, food pipe, gut or bowel (gastrointestinal perforation).
Danish: Dette kan forekomme, hvis du har hul i mavesækken, på spiserøret eller tarmen (gastrointestinal perforation).
English: • painful or frequent urination
Danish: • smertefuld eller hyppig vandladning
English: The in vitro blood-to-plasma concentration ratios in human blood ranged from 0.90 to 0.99 indicating that cabazitaxel was equally distributed between blood and plasma.
Danish: Forholdet mellem blod-plasma koncentrationer i humant blod lå på mellem 0,90 og 0,99 in vitro, hvilket indikerede, at cabazitaxel var ligeligt fordelt mellem blod og plasma.
English: An in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) is recommended during administration.
Danish: Et inline-filter med 0,22 mikrometer nominel porestørrelse (også betegnet som 0,2 mikrometer) anbefales under administrationen.
English: • loss of appetite (anorexia)
Danish: • appetitløshed (anoreksi)
English: These patients received cabazitaxel at doses of 10 to 30 mg/m2 weekly or every 3 weeks.
Danish: Disse patienter modtog cabazitaxel i doser på 10-30 mg/m2 ugentligt eller hver tredje uge.
English: As for any other antineoplastic agent, caution should be exercised when handling and preparing JEVTANA solutions, taking into account the use of containment devices, personal protective equipment (e.g. gloves), and preparation procedures.
Danish: Som med ethvert andet antineoplastisk middel skal der udvises forsigtighed ved håndtering og klargøring af JEVTANA-opløsninger, idet der tages hensyn til brugen af indkapslingsanordninger, personligt beskyttelsesudstyr (f.eks. handsker) og klargøringsprocedurer.
English: Intensity of the adverse reactions is graded according to CTCAE 4.0 (grade ≥3 = G≥3).
Danish: Intensiteten af bivirkninger klassificeres i henhold til CTCAE v4.0 (grad ≥3 = G≥3).
English: This fill volume has been established during the development of JEVTANA to compensate for liquid loss during preparation of the premix.
Danish: Dette påfyldningsvolumen er blevet fastlagt under udviklingen af JEVTANA for at kompensere for væsketab under fremstilling af præmiks.
English: Incidence of grade ≥3 neutropenia based on laboratory data was 81.7%.
Danish: Forekomst af grad ≥3 neutropeni baseret på laboratoriedata var 81,7 %.
English: Throughout the treatment, adequate hydration of the patient needs to be ensured, in order to prevent complications like renal failure.
Danish: Under behandlingen skal det sikres, at patienten hydreres tilstrækkeligt for at forebygge komplikationer, såsom nyresvigt.
English: Confounding causes such as disease progression, instrumentation, infection or anticoagulation/NSAID/aspirin therapy were identified in nearly two thirds of the cases.
Danish: Konfunderende årsager såsom sygdomsprogression, instrumentering, infektion eller behandling med antikoagulans/NSAID/acetylsalicylsyre blev identificeret i næsten to tredjedele af tilfældene.
English: This can occur if you have severe or long-lasting diarrhoea, or fever, or if you are being sick
Danish: Dette kan ske, hvis du har svær eller langvarig diarré eller feber, eller hvis du kaster op.
English: 1.5 ml 10 mg/ml after first dilution.
Danish: 1,5 ml 10 mg/ml efter første fortynding.
English: Grade>3 n (%)
Danish: Grad>3 n (%)
English: In rats, cabazitaxel and its metabolites are excreted in maternal milk at a quantity up to 1.5% of administered dose over 24 hours.
Danish: I rotter udskilles cabazitaxel og dets metabolitter i modermælken i en mængde op til 1,5 % af den indgivne dosis over 24 timer.
English: • corticosteroid (dexamethasone 8 mg or equivalent), and
Danish: • kortikosteroid (dexamethason 8 mg eller tilsvarende) og
English: There are no data from the use of cabazitaxel in pregnant women.
Danish: Der er ingen data fra brug af cabazitaxel hos gravide kvinder.
English: In vitro, the binding of cabazitaxel to human serum proteins was 89-92% and was not saturable up to 50,000 ng/ml, which covers the maximum concentration observed in clinical studies.
Danish: In vitro var bindingen af cabazitaxel til humane serumproteiner 89-92 % og kunne ikke mættes op til 50.000 ng/ml, hvilket omfatter den maksimale koncentration, som er observeret i kliniske studier.
English: As with other cytotoxic medicinal products, cabazitaxel may cause foetal harm in exposed pregnant women.
Danish: Som andre cytotoksiske lægemidler kan cabazitaxel skade fosteret hos eksponerede gravide kvinder.
English: JEVTANA could be present in your semen and may affect the foetus.
Danish: Der kan være JEVTANA i din sæd, og det kan påvirke fosteret.
English: Symptoms such as abdominal pain and tenderness, fever, persistent constipation, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Danish: Symptomer såsom abdominal smerte og ømhed, feber, vedvarende forstoppelse og diarré med eller uden neutropeni kan være tidlige manifestationer på alvorlig gastrointestinal toksicitet og bør evalueres og behandles omgående.
English: Therefore the risk of interaction with substrates of MRP, OCT1, PgP, BCRP and OATP1B3 is unlikely in vivo at the dose of 25 mg/m2.
Danish: Risikoen for interaktion med substrater af MRP, OCT1, PgP, BCRP og OATP1B3 er derfor usandsynlig in vivo ved en dosis på 25 mg/m2.
English: METHOD OF ADMINISTRATION Use the ENTIRE content for dilution (see package leaflet).
Danish: ADMINISTRATIONSMETODE Brug HELE indholdet til fortynding (se indlægssedlen).
English: Interruption of cabazitaxel therapy is recommended until diagnosis is available.
Danish: Afbrydelse af behandling med cabazitaxel anbefales, indtil diagnosen foreligger.
English: This is because JEVTANA may increase the risk of bleeding or developing holes in the gut wall.
Danish: Dette skyldes, at JEVTANA kan øge risikoen for blødning eller for at udvikle huller på tarmen.
English: However, in-use storage time can be longer under specific conditions mentioned in section Shelf life and special precautions for storage above.
Danish: Holdbarheden kan imidlertid være længere under de særlige forhold, der er nævnt ovenfor i afsnittet Holdbarhed og særlige forholdsregler for opbevaring.
English: Cabazitaxel did not induce mutations in the bacterial reverse mutation (Ames) test.
Danish: Cabazitaxel inducerede ikke mutationer i den bakterielle tilbagemutations- (Ames) test.
English: JEVTANA was evaluated in an open label, multi-center Phase 1/2 study conducted in a total of 39 paediatric patients (aged between 4 to18 years for the phase 1 part of the study and between 3 to 16 years for the phase 2 part of the study).
Danish: JEVTANA blev evalueret i et åbent fase 1/2-multicenterstudie hos i alt 39 pædiatriske patienter (i alderen 4 til 18 år for fase 1-delen af studiet og i alderen 3 til 16 år for fase 2-delen af studiet).
English: This medicine contains 15% v/v ethanol (alcohol), equivalent to 14 ml of beer or 6 ml of wine.
Danish: Denne medicin indeholder 15 % v/v ethanol (alkohol), hvilket svarer til 14 ml øl eller 6 ml vin.
English: • rapid or irregular heartbeat
Danish: • hurtigt eller uregelmæssigt hjerteslag
English: Neutropenic complications included neutropenic infections (0.5%), neutropenic sepsis (0.8%), and septic shock (1.1%), which in some cases resulted in a fatal outcome.
Danish: Neutropeniske komplikationer inkluderede neutropeniske infektioner (0,5 %), neutropenisk sepsis (0,8 %) og septisk shock (1,1 %), der i nogle tilfælde resulterede i et dødeligt udfald.
English: Premedication The recommended premedication regimen should be performed at least 30 minutes prior to each administration of JEVTANA with the following intravenous medicinal products to mitigate the risk and severity of hypersensitivity:
Danish: Præmedicinering Det anbefalede præmedicineringsregime skal gives mindst 30 minutter før hver administration af JEVTANA med følgende intravenøse lægemidler for at mindske risikoen for og sværheden af overfølsomhed:
English: The use of JEVTANA should be confined to units specialised in the administration of cytotoxics and it should only be administered under the supervision of a physician experienced in the use of anticancer chemotherapy.
Danish: Brugen af JEVTANA skal begrænses til sygehusafdelinger, der er specialiseret i administration af cytotoksiske stoffer, og det må kun administreres under supervision af en læge med erfaring i kemoterapi mod cancer.
English: • you have kidney problems.
Danish: • du har nyreproblemer.
English: There was no significant difference in overall survival in this group of patients (HR (95%CI) 0.96 (0.49-1.86)).
Danish: Der var ingen signifikant forskel i den samlede overlevelse i denne gruppe patienter (HR (95 %CI) 0.96 (0.49-1.86)).
English: However these genotoxicity findings are inherent to the pharmacological activity of the compound (inhibition of tubulin depolymerization) and have been observed with medicinal products exhibiting the same pharmacological activity.
Danish: Disse genotoksicitetsfund er naturlige for forbindelsens farmakologiske aktivitet, (hæmning af tubulin depolymerisering) og har været observeret ved lægemidler, som udviser den samme farmakologiske aktivitet.
English: Talk to your doctor before getting vaccinations while you are receiving JEVTANA.
Danish: Tal med din læge, inden du bliver vaccineret, mens du får JEVTANA.
English: No major deviation to the dose proportionality was observed from 10 to 30 mg/m² in patients with advanced solid tumours (n=126).
Danish: Der blev ikke observeret nogen større afvigelse i dosis proportionaliteten fra 10 til 30 mg/m² hos patienter med avancerede faste tumorer (n=126).
English: Haematological abnormalitiesc (%)
Danish: Hæmatologiske abnormiteterc (%)
English: Patients with a history of congestive heart failure, or myocardial infarction within last 6 months, or patients with uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension were not included in the study.
Danish: Patienter med fortilfælde af kongestiv hjerteinsufficiens eller myokardieinfarkt inden for de sidste 6 måneder eller patienter med ukontrolleret hjertearytmi, angina pectoris og/eller hypertension blev ikke inkluderet i studiet.
English: Seven metabolites were detected in plasma (including 3 active metabolites issued form O-demethylations), with the main one accounting for 5% of parent exposure.
Danish: Der blev detekteret syv metabolitter i plasma (inklusive 3 aktive metabolitter, som dannes ud fra O-demethyleringer), hvor hovedmetabolitten udgjorde 5 % af eksponeringen.
English: Administration of cabazitaxel to patients with mild hepatic impairment should be undertaken with caution and close monitoring of safety.
Danish: Administration af cabazitaxel til patienter med let nedsat leverfunktion skal foretages med forsigtighed og under tæt monitorering af sikkerheden.
English: Table 3 - Efficacy of JEVTANA in EFC6193 study in the treatment of patients with metastatic castration resistant prostate cancer
Danish: Tabel 3 - Effekt af JEVTANA i EFC6193-studiet ved behandling af patienter med metastatisk kastrationsresistent prostatacancer
English: As the infusion solution is supersaturated, it may crystallize over time.
Danish: Da infusionsvæsken er overmættet, kan den udkrystallisere med tiden.
English: Table 2: Reported adverse reactions and haematological abnormalities with cabazitaxel in combination with prednisone or prednisolone in the TROPIC study (n=371)
Danish: Tabel 2: Rapporterede bivirkninger og hæmatologiske abnormiteter med cabazitaxel i kombination med prednison eller prednisolon i TROPIC studiet (n=371)
English: Severe reactions can occur and may include generalised rash/erythema, hypotension and bronchospasm.
Danish: Svære reaktioner kan forekomme og kan omfatte generaliseret udslæt/erytem, hypotension og bronkospasme.
English: Cabazitaxel crossed the placenta barrier in rats.
Danish: Cabazitaxel krydsede placentabarrieren i rotter.
English: If patients experience nausea or vomiting, they may be treated with commonly used anti-emetics.
Danish: Hvis patienter oplever kvalme eller opkastning, kan de behandles med almindeligt anvendte antiemetika.
English: The mean AUC was 991 ng.h/ml (CV: 34%).
Danish: Middel AUC var 991 nanog·time/ml (CV: 34 %).
English: If patients continue to experience any of these reactions at 20 mg/m2, further dose reduction to 15 mg/m2 or discontinuation of JEVTANA may be considered.
Danish: Hvis patienten fortsat oplever nogen af disse reaktioner ved 20 mg/m2, bør yderligere dosisreduktion til 15 mg/m2 eller seponering af JEVTANA overvejes.
English: Risk of neutropenia
Danish: Risiko for neutropeni
English: Risk of nausea, vomiting, diarrhoea and dehydration If patients experience diarrhoea following administration of cabazitaxel they may be treated with commonly used anti-diarrhoeal medicinal products.
Danish: Risiko for kvalme, opkastning, diarré og dehydrering Hvis patienter oplever diarré efter administration af cabazitaxel, kan de behandles med almindeligt anvendt medicin mod diarré.
English: Men being treated with cabazitaxel are advised to seek advice on conservation of sperm prior to treatment.
Danish: Mænd, som behandles med cabazitaxel, anbefales at søge råd om, hvordan sperma kan konserveres inden behandlingen.
English: Cabazitaxel did not inhibit in vitro the major biotransformation pathway of warfarin into 7-hydroxywarfarin, which is mediated by CYP2C9.
Danish: Cabazitaxel hæmmede ikke in vitro den vigtigste biotransformationsvej for warfarin til 7-hydroxywarfarin, der medieres af CYP2C9.
English: The incidence of atrial fibrillation was 1.1% in the cabazitaxel group.
Danish: Forekomsten af atrieflimren var 1,1 % i cabazitaxel-gruppen.
English: Information about storage and the time to use JEVTANA, once it has been diluted and is ready to use, are described in the section “PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA“.
Danish: Information om opbevaring og om, hvor lang tid JEVTANA kan bruges, når det er blevet fortyndet og klar til brug, er beskrevet i afsnittet "PRAKTISKE OPLYSNINGER TIL LÆGER OG SUNDHEDSPERSONALE OM KLARGØRING OG HÅNDTERING AF JEVTANA".
English: Any of these events could cause severe dehydration.
Danish: Alle disse hændelser kan forårsage svær dehydrering (væsketab).
English: Its common name is cabazitaxel.
Danish: Fællesnavnet er cabazitaxel.
English: To be taken into account in high-risk groups such as patients with liver disease, or epilepsy.
Danish: Der bør tages hensyn hertil i højrisikogrupper, såsom patienter med leversygdom eller epilepsi.
English: • antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent),
Danish: • antihistamin (dexchlorpheniramin 5 mg eller diphenhydramin 25 mg eller tilsvarende)
English: Cabazitaxel may influence the ability to drive and use machines as it may cause fatigue and dizziness.
Danish: Cabazitaxel kan påvirke evnen til at føre motorkøretøj eller betjene maskiner, da det kan forårsage træthed og svimmelhed.
English: Follow the preparation instructions provided below.
Danish: Følg nedenstående instruktioner for præparation.
English: There is no potential risk of inhibition of medicinal products that are substrates of other CYP enzymes (1A2, 2B6, 2C9, 2C8, 2C19, 2E1, and 2D6) as well as no potential risk of induction by cabazitaxel on medicinal products that are substrates of CYP1A, CYP2C9, and CYP3A.
Danish: Der er ingen potentiel risiko for hæmning af lægemidler, der er substrater for andre CYP-enzymer (1A2, 2B6, 2C9, 2C8, 2C19, 2E1, and 2D6), og der er ingen potentiel risiko for, at cabazitaxel giver anledning til induktion af lægemidler, der er substrater for CYP1A, CYP2C9 og CYP3A.
English: CYP3A inhibitors
Danish: CYP3A-inhibitorer
English: Remove the syringe and needle and mix manually and gently by repeated inversions until obtaining a clear and homogeneous solution.
Danish: Fjern sprøjten og kanylen og bland manuelt og forsigtigt ved at vende hætteglasset gentagne gange, indtil der fås en klar og homogen opløsning.
English: Grade ≥3 diarrhoea or persisting diarrhoea despite appropriate treatment, including fluid and electrolytes replacement
Danish: Grad ≥3 diarré eller vedvarende diarré på trods af hensigtsmæssig medicinering, inklusive væske og elektrolyterstatning
English: JEVTANA should only be prepared and administered by personnel trained in handling cytotoxic agents.
Danish: JEVTANA må kun klargøres og indgives af personale, som er uddannet i håndtering af cytotoksiske midler.
English: Secondary endpoints included Progression Free Survival [PFS (defined as time from randomization to tumour progression, Prostatic Specific Antigen (PSA) progression, pain progression, or death due to any cause, whichever occurred first], Tumour Response Rate based on Response Evaluation Criteria in Solid Tumours (RECIST), PSA Progression (defined as a ≥25% increase or >50% in PSA non-responders or responders respectively), PSA response (declines in serum PSA levels of at least 50%), pain progression [assessed using the Present Pain Intensity (PPI) scale from the McGill-Melzack questionnaire and an Analgesic Score (AS)] and pain response (defined as 2-point greater reduction from baseline median PPI with no concomitant increase in AS, or reduction of ≥50% in analgesic use from baseline mean AS with no concomitant increase in pain).
Danish: Sekundære endepunkter inkluderede progressionsfri overlevelse [PFS (defineret som tid fra randomisering til tumorprogression, prostatisk specifik antigen (PSA) -progression, smerteprogression eller død uanset årsagen, hvad der forekommer først], tumor responsrate baseret på respons evalueringskriterier i faste tumorer (RECIST), PSA-progression (defineret som en henholdsvis ≥25 % stigning eller >50 % hos PSA ikke-respondere eller respondere), PSArespons (fald i serum PSA-niveauer på mindst 50 %), smerteprogression [vurderet ved hjælp af Present Pain Intensity (PPI) -skalaen fra McGill-Melzack spørgeskemaet og en analgetisk score (AS)] og smerterespons (defineret som 2-punkts større reduktion fra baseline median PPI uden nogen samtidig stigning i AS eller reduktion på ≥50 % i brug af analgetika i forhold til baseline middelværdi for AS uden nogen samtidig stigning i smerte).
English: The dose should be reduced in case of febrile neutropenia, or prolonged neutropenia despite appropriate treatment (see section 4.2).
Danish: Dosis bør reduceres i tilfælde af febril neutropeni eller langvarig neutropeni trods passende behandling (se pkt.
English: Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines.
Danish: Fortæl altid lægen, apotekspersonalet eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Therefore, no pharmacokinetic interaction of cabazitaxel on warfarin is expected in vivo.
Danish: Der forventes således ikke nogen farmakokinetisk interaktion af cabazitaxel på warfarin in vivo.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vials after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der er anført på yderemballagen og på hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • kidney disease or problems
Danish: • nyresygdom eller -problemer
English: The anticipated complications of overdose would consist of exacerbation of adverse reactions as bone marrow suppression and gastrointestinal disorders.
Danish: De forventede komplikationer fra overdosering ville være eksacerbation af bivirkninger såsom knoglemarvssuppression og gastrointestinale sygdomme.
English: This study included patients over 18 years of age with metastatic castration resistant prostate cancer either measurable by RECIST criteria or non-measurable disease with rising PSA levels or appearance of new lesions, and Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Danish: Dette studie omfattede patienter over 18 år med metastatisk kastrationsresistent prostatacancer, enten målelig med RECIST-kriterierne eller ikke-målelig sygdom med stigende PSA-niveauer eller forekomst af nye læsioner og en ECOG (Eastern Cooperative Oncology Group) performance status på 0 til 2.
English: The concentrate solution and the solvent should be clear.
Danish: Koncentratopløsningen og solvensen skal være klar.
English: Vaccination with a live attenuated vaccine should be avoided in patients receiving cabazitaxel.
Danish: Vaccination med en levende, svækket vaccine bør undgås hos patienter, der er i behandling med cabazitaxel.