FrancophonIA/ELRC3.0 huggingface dataset:
English: Since foam may persist on the wall of the vial of this solution, following its preparation described in Step 1, it is preferable to place the needle of the syringe in the middle when extracting.
Danish: Da der stadig kan sidde skum på hætteglassets inderside, efter at blandingen er klargjort i Trin 1, er det bedst at placere kanylen i midten, når blandingen ekstraheres.
English: Haematuria all grades frequency was 20.8% at 25 mg/m2 in EFC11785 study (see section 5.1).
Danish: Hyppigheden af alle grader af hæmaturi var 20,8 % ved 25 mg/m2 i EFC11785-studiet (se pkt.
English: For the pack of JEVTANA 60 mg concentrate and solvent Do not store above 30°C.
Danish: For pakken med JEVTANA 60 mg koncentrat og solvens Må ikke opbevares ved temperaturer over 30 °C.
English: The European Medicines Agency has waived the obligation to submit the results of studies with JEVTANA in all subsets of the paediatric population in the indication of prostate cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med JEVTANA i alle undergrupper af den pædiatriske population med prostatacancer (se pkt.
English: The risk of interaction with OATP1B1 substrates (e.g. statins, valsartan, repaglinide) is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion.
Danish: Der er en potentiel risiko for interaktion med OATP1B1-substrater (f.eks. statiner, valsartan, repaglinid), især under infusionen (1 time) og i op til 20 minutter efter infusionens afslutning.
English: The study met its primary objective of demonstrating the non-inferiority of cabazitaxel 20 mg/m2 in comparison with 25 mg/m2 (see table 4).
Danish: Studiet mødte det primære mål at demonstrere noninferioritet af cabazitaxel 20 mg/m2 sammenlignet med 25 mg/m2 (se tabel 4).
English: The concentration of the infusion solution should be between 0.10 mg/ml and 0.26 mg/ml.
Danish: Koncentrationen af infusionsvæsken skal være mellem 0,10 mg/ml og 0,26 mg/ml.
English: Study EFC11785 demonstrated a better safety profile for the cabazitaxel 20 mg/m2 dose.
Danish: EFC11785-studiet viste en bedre sikkerhedsprofil for cabazitaxel 20 mg/m2-dosen.
English: Gastrointestinal hemorrhage and perforation, ileus and intestinal obstruction have also been reported (see section 4.4).
Danish: Gastrointestinal blødning og perforation, ileus og intestinal obstruktion er også blevet rapporteret (se pkt.
English: In the JEVTANA group, the mean age was 68 years, range (46-92) and the racial distribution was 83.9% Caucasian, 6.9% Asian/Oriental, 5.3% Black and 4% Others.
Danish: I JEVTANA-gruppen var gennemsnitsalderen 68 år, intervallet (46-92) og racefordelingen 83,9 % hvide, 6,9 % asiater, 5,3 % sorte og 4 % andre.
English: As part of your treatment, you will also take a corticosteroid medicine (prednisone or prednisolone) by mouth every day.
Danish: I forbindelse med din behandling vil du også få kortikosteroid-medicin (prednison eller prednisolon) oralt hver dag.
English: Contains an overfill.
Danish: Påfyldt et overskud.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hour at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke anvendes med det samme, er brugeren ansvarlig for holdbarheden og for de forhold, som den opbevares under, hvilket normalt ikke vil være mere end 24 timer ved 2 °C-8 °C, medmindre fortyndingen har fundet sted under kontrollerede og validerede aseptiske forhold.
English: A statistically significantly higher percentage (p<0.001) of patients showed a PSA response in the 25 mg/m2 group (42.9%) compared to the 20 mg/m2 group (29.5%).
Danish: En statistisk signifikant højere procentdel (p <0,001) af patienterne udviste et PSA-respons i 25 mg/m2-gruppen (42,9 %) sammenlignet med 20 mg/m2-gruppen
English: Required amount of concentrate-solvent mixture
Danish: Nødvendigt volumen af koncentrat + solvens-blanding
English: The dose of cabazitaxel should be reduced from 25 mg/m2 to 20 mg/m2 for persistent grade >2 peripheral neuropathy (see section 4.2).
Danish: Dosis af cabazitaxel bør reduceres fra 25 mg/m2 til 20 mg/m2 ved persisterende grad >2 perifer neuropati (se pkt.
English: Exposures in animals were lower than those seen in humans receiving clinically relevant doses of cabazitaxel.
Danish: Eksponering hos dyr var lavere end dem, der ses hos mennesker, som modtager klinisk relevante doser af cabazitaxel.
English: If the treatment is envisaged in patients with moderate hepatic impairment the dose of cabazitaxel should not exceed 15 mg/m2.
Danish: Hvis behandling af patienter med moderat nedsat leverfunktion planlægges, bør dosis af cabazitaxel ikke overstige 15 mg/m2.
English: Diarrhoea can occur more frequently in patients that have received prior abdomino-pelvic radiation.
Danish: Diarré kan forekomme hyppigere hos patienter, der tidligere har modtaget bestråling af bug- og bækkenhulerne.
English: From 25 to 20 mg/m2: 128 (21.5%) From 20 to 15 mg/m2: 19 (3.2%) From 15 to 12 mg/m2: 1 (0.2%)
Danish: Fra 25 til 20 mg/m2: 128 (21,5%) Fra 20 til 15 mg/m2: 19 (3,2%) Fra 15 til 12 mg/m2: 1 (0,2%)
English: As an example, a dose of 45 mg JEVTANA would require 4.5 ml of the concentrate-solvent mixture prepared following Step 1.
Danish: Som eksempel vil en dosis på 45 mg JEVTANA kræve 4,5 ml af koncentrat + solvens-blandingen, fremstillet som beskrevet i Trin 1.
English: The safety profile of cabazitaxel 25 mg/m2 observed in study EFC11785 was qualitatively and quantitatively similar to that observed in the study EFC6193.
Danish: Sikkerhedsprofilen for cabazitaxel 25 mg/m2 observeret i dette studie var kvalitativt og kvantitativt svarerende til det observerede i EFC6193-studiet.
English: One pack of JEVTANA contains:
Danish: Pakningsstørrelser og yderligere oplysninger JEVTANA indeholder:
English: The MTD of cabazitaxel in patients with severe hepatic impairment was not established.
Danish: MTD af cabazitaxel hos patienter med svært nedsat leverfunktion blev ikke fastlagt.
English: Cabazitaxel had a high plasma clearance of 48.5 l/h (26.4 l/h/m² for a patient with a median BSA of 1.84 m²) and a long terminal half-life of 95 hours.
Danish: Cabazitaxel havde en høj plasma clearance på 48,5 l/t (26,4 l/t/m² for en patient med en median BSA på 1,84 m²) og en lang terminal halveringstid på 95 timer.
English: • you have severe abnormal liver function,
Danish: • din lever fungerer meget dårligt,
English: More than one vial of the concentrate-solvent mixture may be necessary to administer the prescribed dose.
Danish: Det kan være nødvendigt at anvende mere end et hætteglas af koncentrat + solvens blandingen for at administrere den ordinerede dosis.
English: • ringing in the ear
Danish: • ringen for øret
English: In 3 patients with severe hepatic impairment (total bilirubin >3 ULN), a 39% decrease in clearance was observed when compared to patients with mild hepatic impairment, indicating some effect of severe hepatic impairment on cabazitaxel pharmacokinetics.
Danish: Hos 3 patienter med svært nedsat leverfunktion (total-bilirubin >3 ULN) blev et fald i clearance på 39 % observeret, sammenlignet med patienter med let nedsat leverfunktion, hvilket indikerer en vis påvirkning af cabazitaxels farmakokinetik ved svært nedsat leverfunktion.
English: For instructions on preparation and administration of the product, see section 6.6.
Danish: For instruktioner i klargøring og administration af præparatet se pkt.
English: To be taken into account if you are in a high-risk group such as patients with liver disease, or epilepsy.
Danish: Der skal tages hensyn hertil, hvis du er i en højrisikogruppe f.eks. har en leversygdom eller epilepsi.
English: The maximum tolerated dose (MTD) of cabazitaxel was 20 and 15 mg/m2, respectively.
Danish: Den maksimale tolererede dosis (MTD) af cabazitaxel var hhv. 20 og 15 mg/m2.
English: Concentrate Polysorbate 80 Citric acid
Danish: SDS-koncentrat Polysorbat 80 Citronsyre
English: Animal studies showed that cabazitaxel affected reproductive system in male rats and dogs without any functional effect on fertility (see section 5.3).
Danish: Dyrestudier har vist, at cabazitaxel påvirkede det reproduktive system hos hanrotter og -hunde, uden at det havde nogen indvirkning på fertiliteten (se pkt.
English: The recommended dose of JEVTANA is 25 mg/m2 administered as a 1 hour intravenous infusion every 3 weeks in combination with oral prednisone or prednisolone 10 mg administered daily throughout treatment.
Danish: Den anbefalede dosis af JEVTANA er 25 mg/m2 administreret som 1 times intravenøs infusion hver 3. uge i kombination med oral administration af prednison eller prednisolon 10 mg dagligt under hele behandlingen.
English: After 1-hour intravenous administration at 25 mg/m2 cabazitaxel in patients with metastatic prostate cancer (n=67), the Cmax was 226 ng/ml (Coefficient of Variation (CV): 107%) and was reached at the end of the 1-hour infusion (Tmax).
Danish: Efter 1-times intravenøs administration af cabazitaxel ved 25 mg/m2 hos patienter med metastatisk prostatacancer (n=67) var Cmax 226 nanog/ml (variationskoefficient (CV): 107 %), og den blev nået efter 1-times infusion (Tmax).
English: Alopecia Dry skin Erythema
Danish: Alopeci Tør hud Erytem
English: Gastrointestinal (GI) hemorrhage and perforation, ileus, colitis, including fatal outcome, have been reported in patients treated with cabazitaxel (see section 4.8).
Danish: Gastrointestinal (GI) blødning og perforation, ileus, colitis, inklusive dødelige tilfælde, er rapporteret hos patienter behandlet med cabazitaxel (se pkt.
English: Cabazitaxel demonstrated a broad spectrum of antitumour activity against advanced human tumours xenografted in mice.
Danish: Cabazitaxel udviste et bredt spektrum af antitumoraktiviteter over for avancerede humane tumorer xenotransplanteret hos mus.
English: Repeated administration of rifampin (600 mg once daily), a strong CYP3A inducer, resulted in an increase in cabazitaxel clearance of 21% corresponding to a decrease in AUC of 17%.
Danish: Gentagen administration af rifampin (600 mg én gang daglig), en potent CYP3A-induktor, resulterede i 21 % stigning i cabazitaxel-clearance svarende til et fald i AUC på 17 %.
English: Adverse reactions not observed in clinical studies, but seen in rats during repeat-dose toxicity studies at exposure levels higher than clinical exposure levels and with possible relevance to clinical use were eye disorders characterized by subcapsular lens fiber swelling/degeneration.
Danish: Bivirkninger, som ikke er blevet observeret i kliniske studier, men som er set i rotter under toksicitetsstudier med gentagne doser ved højere eksponeringsniveauer end kliniske eksponeringsniveauer og med mulig relevans for klinisk brug, var øjensygdomme, som var karakteriseret ved subkapsulær hævelse/degeneration af linsefibre.
English: Practical information for handling and administration of JEVTANA for doctors, nurses and pharmacists is provided with this leaflet.
Danish: Indlægssedlen indeholder praktiske oplysninger om håndtering og indgivelse af JEVTANA for læger, sygeplejersker og farmaceuter (apoteket).
English: PRACTICAL INFORMATION FOR MEDICAL OR HEALTHCARE PROFESSIONALS ON PREPARATION, ADMINISTRATION AND HANDLING OF JEVTANA 60 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Danish: Nedenstående oplysninger er til læger og sundhedspersonale PRAKTISKE OPLYSNINGER FOR LÆGER OG SUNDHEDSPERSONALE OM KLARGØRING, ADMINISTRATION OG HÅNDTERING AF JEVTANA 60 mg KONCENTRAT OG SOLVENS TIL INFUSIONSVÆSKE, OPLØSNING
English: Cases of peripheral neuropathy, peripheral sensory neuropathy (e.g., paraesthesias, dysaesthesias) and peripheral motor neuropathy have been observed in patients receiving cabazitaxel.
Danish: Der er observeret tilfælde af perifer neuropati, perifer sensorisk neuropati (f.eks. paræstesier og dysæstesier) og perifer motorisk neuropati hos patienter, der behandles med cabazitaxel.
English: Inject the entire contents into the corresponding concentrate vial.
Danish: Injicer hele indholdet ned i hætteglasset med koncentrat.
English: After initial dilution of JEVTANA 60 mg concentrate with the entire contents of the solvent vial chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature.
Danish: Efter den indledende fortynding af JEVTANA 60 mg koncentrat med hele indholdet af hætteglasset med solvens er der påvist kemisk og fysisk stabilitet under brug i 1 time ved stuetemperatur.
English: This was confirmed by a dedicated comparative pharmacokinetic study in solid cancer patients with normal renal function (8 patients), moderate (8 patients) and severe (9 patients) renal impairment, who received several cycles of cabazitaxel in single IV infusion up to 25 mg/m2.
Danish: Dette blev bekræftet af et specifikt komparativt farmakokinetisk studie med patienter med solide tumorer og med normal nyrefunktion (8 patienter), moderat nedsat (8 patienter) og svært nedsat (9 patienter) nyrefunktion, som fik flere serier af cabazitaxel op til 25 mg/m2 som en enkelt i.v.-infusion.
English: A hazard ratio < 1 indicates a lower risk of cabazitaxel 20 mg/m2 with respect to 25 mg/m2.
Danish: Hazard ratio <1 indikerer en lavere risiko for Cabazitaxel 20 mg/m2 i forhold til 25 mg/m2.
English: In addition, cabazitaxel demonstrated activity in tumour models insensitive to chemotherapy including docetaxel.
Danish: Cabazitaxel udviste desuden aktivitet i tumormodeller, som er ufølsomme over for kemoterapi inklusiv docetaxel.
English: Cabazitaxel did not affect mating performances or fertility of treated male rats.
Danish: Cabazitaxel påvirkede ikke parringspræstationen eller fertiliteten af behandlede hanrotter.
English: However, in repeated-dose toxicity studies, degeneration of seminal vesicle and seminiferous tubule atrophy in the testis were observed in rats, and testicular degeneration (minimal epithelial single cell necrosis in epididymis), was observed in dogs.
Danish: Ved toksicitetsstudier med gentagne doser blev der observeret degenation af sædblære og atrofi i sædkanalerne i testiklerne hos rotter, og der blev observeret testikulær degeneration (minimal enkelt-epitelcellenekrose i epididymis) i hunde.
English: Remove the syringe and mix the content of the infusion bag or bottle manually using a rocking motion.
Danish: Træk kanylen ud og bland indholdet i infusionsposen eller -flasken manuelt med en vippende bevægelse.
English: The risk of interaction with OATP1B1 transporter is possible, notably during the infusion duration (1 hour) and up to 20 minutes after the end of the infusion (see section 4.5).
Danish: Risikoen for interaktion med OATP1B1-transportøren er begrænset til infusionens varighed (1 time) og op til 20 minutter efter infusionens afslutning (se pkt.
English: After initial dilution of the concentrate with the solvent Chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature (15°C-30°C).
Danish: Efter indledende fortynding af koncentratet med solvensen Kemisk og fysisk stabilitet under brug er blevet påvist i 1 time ved stuetemperatur (15 °C-30 °C).
English: A total of 755 patients were randomised to receive either JEVTANA 25 mg/m2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone or prednisolone 10 mg orally daily (n=378), or to receive mitoxantrone 12 mg/m2 intravenously every 3 weeks for a maximum of 10 cycles with prednisone or prednisolone 10 mg orally daily (n=377).
Danish: I alt 755 patienter blev randomiseret til enten at modtage JEVTANA 25 mg/m2 intravenøst hver 3. uge i højst 10 serier med prednison eller prednisolon 10 mg oralt dagligt (n=378) eller til at modtage mitoxantron 12 mg/m2 intravenøst hver 3. uge i maksimalt 10 serier med prednison eller prednisolon 10 mg oralt dagligt (n=377).
English: Due to potential exposure via seminal liquid, men treated with cabazitaxel should prevent contact with the ejaculate by another person throughout treatment.
Danish: På grund af potentiel eksponering via seminalvæsken skal mænd, som behandles med cabazitaxel, i hele behandlingsperioden undgå, at andre kommer i kontakt med ejakulatet.
English: Excipient with known effect Each vial of solvent contains 573.3 mg of ethanol 96%.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hvert hætteglas med solvens indeholder 573,3 mg ethanol 96 %.
English: Caution is advised with treatment of patients most at risk of developing gastrointestinal complications: those with neutropenia, the elderly, concomitant use of NSAIDs, anti-platelet therapy or anti-coagulants, and patients with a prior history of pelvic radiotherapy or gastrointestinal disease, such as ulceration and GI bleeding.
Danish: Der bør udvises forsigtighed ved behandling af patienter, der især har risiko for at udvikle gastrointestinale komplikationer: neutropene patienter, ældre, samtidig brug af NSAID, trombocythæmmer eller antikoagulans, samt patienter, der tidligere har fået strålebehandling af bækkenet eller har haft gastrointestinal sygdom, såsom ulceration og GIblødning.
English: JEVTANA must not be mixed with any other medicinal products than those mentioned.
Danish: JEVTANA må ikke blandes med andre lægemidler end de anførte.
English: • low blood potassium
Danish: • lavt blodkalium
English: Clinical neutropenia Urinary tract infection Peripheral sensory neuropathy
Danish: Klinisk neutropeni Urinvejsinfektion Perifer sensorisk neuropati Dysgeusi
English: Concentrate vial: polysorbate 80 and citric acid; Solvent vial: ethanol 96% and water for injections.
Danish: Hætteglas med koncentrat: polysorbat 80 og citronsyre; Hætteglas med solvens: ethanol 96 % og vand til injektionsvæsker.
English: A statistically significantly higher risk of PSA progression in patients with the 20 mg/m2 dose with respect to the 25 mg/m2 dose was observed (HR 1.195 ; 95%CI: 1.025 to 1.393).
Danish: En statistisk signifikant højere risiko for PSA-progression blev observeret hos patienter, der fik 20 mg/m2 dosis, i forhold til 25 mg/m2 (HR 1,195; 95 % CI: 1,025-1,393).
English: A population pharmacokinetic analysis carried out in 170 patients that included 14 patients with moderate renal impairment (creatinine clearance in the range of 30 to 50 ml/min) and 59 patients with mild renal impairment (creatinine clearance in the range of 50 to 80 ml/min) showed that mild to moderate renal impairment did not have meaningful effects on the pharmacokinetics of cabazitaxel.
Danish: En farmakokinetisk populationsanalyse, der blev udført hos 170 patienter, omfattede 14 patienter med moderat nedsat nyrefunktion (kreatininclearance i området 30-50 ml/min) og 59 patienter med let nedsat nyrefunktion (kreatininclearance i området 50-80 ml/min), og den viste, at let til moderat nedsat nyrefunktion ikke havde nogen væsentlig indvirkning på cabazitaxels farmakokinetik.
English: 1 vial of 1.5 ml concentrate and 1 vial of 4.5 ml solvent.
Danish: 1 hætteglas med koncentrat på 1,5 ml og 1 hætteglas med solvens på 4,5 ml.
English: Dose modification
Danish: Dosisændring
English: The most common adverse reactions leading to cabazitaxel discontinuation was neutropenia.
Danish: Den bivirkning, som hyppigst medførte seponering af cabazitaxel, var neutropeni.
English: From a microbiological point of view, the infusion solution should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal infusionsvæsken anvendes med det samme.
English: However, in-use storage time can be longer under specific conditions mentioned in section 6.3.
Danish: Holdbarheden kan imidlertid være længere under de særlige forhold, der er nævnt i pkt.
English: Using a syringe fitted with a needle, aseptically withdraw the entire contents of the supplied solvent by partially inverting the vial.
Danish: Brug en sprøjte med påsat kanyle til aseptisk at trække hele indholdet ud af det medfølgende hætteglas med solvens ved at vende det delvist på hovedet.
English: The efficacy and safety of JEVTANA in combination with prednisone or prednisolone were evaluated in a randomised, open-label, international, multi-center, phase III study (EFC6193 study), in patients with metastatic castration resistant prostate cancer previsouly treated with a docetaxel containing regimen.
Danish: Effekten og sikkerheden af JEVTANA i kombination med prednison eller prednisolon blev evalueret i et randomiseret, åbent, internationalt fase III-multicenterstudie (EFC6193-studiet) hos patienter med metastatisk kastrationsresistent prostatacancer, der tidligere var blevet behandlet med et regime indeholdende docetaxel.
English: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (15°C - 30°C) including the 1-hour infusion time and for 48 hours at refrigerated conditions including the 1-hour infusion time.
Danish: Kemisk og fysisk stabilitet af infusionsvæsken er blevet påvist i 8 timer ved stuetemperatur (15 ºC30 ºC) inklusive infusionstiden på 1 time og i 48 timer ved opbevaring i køleskab inklusive infusionstiden på 1 time.
English: Based on safety and tolerability data, cabazitaxel dose should be reduced in patients with mild hepatic impairment (see sections 4.2, 4.4).
Danish: Baseret på sikkerhed- og tolerabilitetsdata, skal dosis af cabazitaxel reduceres hos patienter med let nedsat leverfunktion (se pkt.
English: Number of patients with deaths (%) Median survival (months) (95% CI) Hazard Ratio (HR)1 (95% CI)
Danish: Median overlevelse (måneder) (95 % CI) Hazard ratio (HR)1 (95 % CI) p-værdi
English: Step 1: Initial dilution of the concentrate for solution for infusion with the supplied solvent.
Danish: Trin 1: Indledende fortynding af koncentratet til infusionsvæske med den medfølgende solvens.
English: Repeated administration of ketoconazole (400 mg once daily), a strong CYP3A inhibitor, resulted in a 20% decrease in cabazitaxel clearance corresponding to a 25% increase in AUC.
Danish: Gentagen administration af ketoconazol (400 mg én gang daglig), en potent CYP3A-hæmmer, resulterede i et fald i cabazitaxel-clearance på 20 % svarende til 25 % stigning i AUC.
English: • abnormal feeling or loss of sensation or pain in hands and feet
Danish: • unormal fornemmelse eller følelsestab eller smerter i hænder og fødder
English: • sore in the mouth or on lips
Danish: • sår i munden eller på læberne
English: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris France
Danish: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris Frankrig
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
Danish: Indehaver af markedsføringstilladelsen sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris Frankrig
English: JEVTANA in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen (see section 5.1).
Danish: JEVTANA i kombination med prednison eller prednisolon er indiceret til behandling af voksne patienter med metastatisk kastrationsresistent prostatacancer, der tidligere er blevet behandlet med et regime indeholdende docetaxel (se pkt.
English: Patients had to have neutrophils >1,500/mm3, platelets >100,000/mm3, haemoglobin >10 g/dl, creatinine <1.5 x ULN, total bilirubin <1 x ULN, AST and ALT <1.5 x ULN.
Danish: Patienter skulle have neutrofilocytter >1.500/mm3, trombocytter >100.000/mm3, hæmoglobin >10 g/dl, kreatinin <1,5 x ULN, total-bilirubin <1 x øvre normalgrænse (ULN), ASAT og ALAT <1,5 x ULN.