FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions not observed in clinical studies, but seen in dogs after single dose, 5-day and weekly administation at exposure levels lower than clinical exposure levels and with possible relevance to clinical use were arteriolar/periarterolar necrosis in the liver, bile ductule hyperplasia and/or hepatocellular necrosis (see section 4.2).
Danish: Bivirkninger, som ikke blev observeret i kliniske studier, men som blev set i hunde efter en administration af en enkelt dosis hver 5. dag eller en gang om ugen ved eksponeringsniveauer, som var lavere end kliniske eksponeringsniveauer og med mulig relevans for klinisk brug, var arteriolar/periarterolar nekrose i leveren, ductulus hyperplasi i galden og/eller hepatocellulær nekrose (se pkt.
English: Interstitial pneumonia/pneumonitis and interstitial lung disease have been reported and may be associated with fatal outcome (see section 4.8).
Danish: Interstitiel pneumoni/pneumonitis og interstitiel lungesygdom er rapporteret og kan være forbundet med dødeligt udfald (se pkt.
English: Oropharyngeal pain Pneumonia
Danish: Orofaryngeale smerter Pneumoni
English: This resulting concentrate-solvent mixture contains 10 mg/ml of cabazitaxel (at least 6 ml deliverable volume).
Danish: Denne blanding af koncentrat og solvens indeholder 10 mg/ml cabazitaxel (ekstraherbart volumen på mindst 6 ml).
English: Bone marrow suppression manifested as neutropenia, anaemia, thrombocytopenia, or pancytopenia may occur (see “Risk of neutropenia” and “Anaemia” in section 4.4 below).
Danish: Knoglemarvsdepression manifesteret som neutropeni, anæmi, trombocytopeni eller pancytopeni kan forekomme (se ”Risiko for neutropeni” og ”Anæmi” i pkt.
English: Patients with a hypersensitivity reaction must stop treatment with JEVTANA (see section 4.3).
Danish: Hos patienter med overfølsomhedsreaktioner skal behandling med JEVTANA seponeres (se pkt.
English: The infusion solution should be used immediately.
Danish: Infusionsvæsken skal anvendes med det samme.
English: 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion
Danish: 5 % glucose- eller natriumchlorid 9 mg/ml (0,9 %) infusionsvæske
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL for CONCENTRATE
Danish: MINDSTEKRAV TIL MÆRKNING, PÅ SMÅ INDRE EMBALLAGER ETIKET TIL HÆTTEGLAS MED KONCENTRAT
English: Summary of safety profile
Danish: Resumé af bivirkningsprofilen
English: Concomitant medicinal products that are strong inducers or strong inhibitors of CYP3A should be avoided.
Danish: Samtidig behandling med lægemidler, der er potente induktorer eller potente hæmmere af CYP3A, bør undgås (se pkt.
English: • Hypersensitivity to cabazitaxel, to other taxanes, or polysorbate 80 or any excipients listed in section 6.1.
Danish: • Overfølsomhed over for cabazitaxel, andre taxaner, polysorbat 80, eller et af de øvrige hjælpestoffer anført i pkt.
English: CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone a All grade adverse reactions with an incidence higher than 10% b Grade ≥ 3 adverse reactions with an incidence higher than 5% c Based on laboratory values
Danish: CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednison/Prednisolon a Bivirkninger af enhver grad med en hyppighed over 10% b Grad ≥ 3 bivirkninger med en hyppighed over 5% c Baseret på laboratorieværdier
English: All Grade events among cardiac disorders were more common on cabazitaxel of which 6 patients (1.6%) had Grade ≥3 cardiac arrhythmias.
Danish: Alle grader af hjertelidelser var hyppigere forekommende i cabazitaxel-gruppen, hvoraf 6 patienter (1,6 %) havde hjertearytmier grad ≥3.
English: • uncomfortable feeling in the stomach, heart burn or belching
Danish: • ubehagelig fornemmelse i maven, halsbrand eller ræben
English: Therefore concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) should be avoided as an increase of plasma concentrations of cabazitaxel may occur (see sections 4.2 and 4.4).
Danish: Derfor skal samtidig administration af potente CYP3A-hæmmere (f.eks. ketoconazol, itraconazol, clarithromycin, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazol) undgås, da en stigning i plasmakoncentrationen af cabazitaxel kan forekomme.
English: In patients with moderate hepatic impairment (total bilirubin >1.5 to ≤ 3.0 x ULN), the maximum tolerated dose (MTD) was 15 mg/m2.
Danish: Hos patienter med moderat nedsat leverfunktion (total-bilirubin >1,5 til ≤3,0 x ULN) var den maksimale tolererede dosis (MTD) 15 mg/m2.
English: The solvent contains 573.3 mg ethanol 96% (15% v/v), equivalent to 14 ml of beer or 6 ml of wine.
Danish: Et hætteglas med solvens indeholder 573,3 mg ethanol 96 %, svarende til 14 ml øl eller 6 ml vin.
English: JEVTANA + prednisone n=378
Danish: JEVTANA + prednison mitoxantron + prednison n=378
English: In vitro, cabazitaxel has also been shown to inhibit the transport proteins of the Organic Anion Transport Polypeptides OATP1B1.
Danish: Det er vist in vitro, at cabazitaxel hæmmer det organisk anion-transporterende polypeptid OATP1B1.
English: The most commonly (≥10%) occurring adverse reactions in all grades were anaemia (97.3%), leukopenia (95.7%), neutropenia (93.5%), thrombocytopenia (47.4%), and diarrhoea (46.6%).
Danish: De hyppigst forekommende (≥ 10 %) bivirkninger i alle grader var anæmi (97,3 %), leukopeni (95,6 %), neutropeni (93,5 %), trombocytopeni (47,4 %) og diarré (46,6 %).
English: Your doctor may need to treat you.
Danish: Din læge kan være nødt til at behandle dig for dehydrering (væsketab).
English: Renal colic Haematuria Pollakiuria Hydronephrosis Urinary retention Urinary incontinence Ureteric obstruction
Danish: Nyrekolik Hæmaturi Pollakisuri Hydronefrose Urinretention Urininkontinens Ureter obstruktion
English: • swelling of the feet or legs
Danish: • hævelse i fødder eller ben
English: Other medicines and JEVTANA
Danish: Brug af anden medicin sammen med JEVTANA
English: Inject in a sterile PVC-free container of either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: Injicer blandingen i en steril PVC-fri infusionsbeholder med enten 5 % glucoseeller natriumchlorid 9 mg/ml (0,9 %) infusionsvæske.
English: • you have feeling of numbness, tingling, burning or decreased sensation in your hands or feet.
Danish: • du oplever følelsesløshed, prikken eller en brændende eller nedsat følelse i hænder eller fødder.
English: In addition, patients should also refrain from taking St. John's Wort.
Danish: Patienter skal desuden undgå at indtage perikon.
English: One pack contains one vial of concentrate and one vial of solvent:
Danish: En pakke indeholder et hætteglas med koncentrat og et hætteglas med solvens:
English: Therefore concomitant administration of strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital) should be avoided as a decrease of plasma concentrations of cabazitaxel may occur (see sections 4.2 and 4.4).
Danish: Derfor skal samtidig indgift af potente CYP3A-induktorer (f.eks. phenytoin, carbamazepin, rifampin, rifabutin, rifapentin, phenobarbital) undgås, da et fald i plasmakoncentrationen af cabazitaxel kan forekomme (se pkt.
English: This fill volume has been established during the development and the overfill ensures, after the addition of the entire content of the solvent vial to the content of JEVTANA 60 mg concentrate vial, a concentration of the premix solution of 10 mg/ml JEVTANA.
Danish: Dette påfyldningsvolumen er fastsat under udviklingen, og overskuddet sikrer, at der efter tilsætning af hele indholdet i hætteglasset med solvens til hætteglasset med JEVTANA 60 mg koncentrat, fås en præmiksopløsning med en koncentration på 10 mg/ml JEVTANA.
English: The active substance is cabazitaxel.
Danish: Aktiv stof: cabazitaxel.
English: Transaminases increased a based on laboratory values
Danish: Forhøjet ASAT Forhøjede levertransaminaser a baseret på laboratorieværdier * se detaljeret pkt.
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis det skulle komme i kontakt med slimhinderne, skal der straks skylles grundigt med vand.
English: • Severe hepatic impairment (total bilirubin >3 x ULN).
Danish: • Svært nedsat leverfunktion (total-bilirubin >3 x ULN).
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Danish: Hvis de ikke anvendes med det samme, vil brugeren være ansvarlig for, hvor længe og hvordan de opbevares for at kunne anvendes.
English: A time interval of 12 hours is recommended before the infusion and at least 3 hours after the end of infusion before administering the OATP1B1 substrates.
Danish: Det anbefales, at OATP1B1-substrater ikke administreres i tidsrummet fra 12 timer før infusionen til mindst 3 timer efter infusionens afslutning.
English: OTHER This vial contains an overfill.
Danish: Disse oplysninger supplerer pkt.
English: Therefore, at therapeutic doses, co-administration of CYP3A substrates with cabazitaxel to patients is not expected to have any clinical impact.
Danish: Samtidig administration af CYP3A-substrater og cabazitaxel i terapeutiske doser forventes derfor ikke at have nogen klinisk betydning.
English: The concentrate and solvent vials must be used immediately.
Danish: Hætteglassene med koncentrat og solvens skal anvendes med det samme.
English: A dedicated study in 43 cancer patients with hepatic impairment showed no influence of mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN) or moderate (total bilirubin >1.5 to ≤3.0 x ULN) hepatic impairment on cabazitaxel pharmacokinetics.
Danish: Et dedikeret studie med 43 cancerpatienter med nedsat leverfunktion viste ingen påvirkning af cabazitaxels farmakokinetik ved let (total-bilirubin >1 til ≤1,5 x ULN eller ASAT >1,5 x ULN) eller moderat (total-bilirubin >1,5 til ≤3,0 x ULN) nedsat leverfunktion.
English: Neutropenia is the most common adverse reaction of cabazitaxel (see section 4.8).
Danish: Neutropeni er den mest almindelige bivirkning forårsaget af cabazitaxel (se pkt.
English: Patients received a median duration of 6 cycles of cabazitaxel.
Danish: Den mediane behandlingsvarighed var 6 serier cabazitaxel.
English: JEVTANA should not be used during breast-feeding.
Danish: JEVTANA må ikke bruges under amning.
English: Table 5 - Summary of safety data for cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm in EFC11785 study
Danish: Table 5 Resume af sikkerhedsdata for cabazitaxel 25 mg/m2 versus cabazitaxel 20 mg/m2 i EFC11785studiet CBZ20+PRED n=580
English: The use of G-CSF has been shown to limit the incidence and severity of neutropenia (see sections 4.2 and 4.4).
Danish: Brugen af G-CSF er blevet påvist at begrænse forekomsten og sværhedsgraden af neutropeni (se pkt.
English: The number of patients who completed the study treatment (10 cycles) was respectively 29.4% and 13.5% in the JEVTANA group and in the comparator group.
Danish: Det antal patienter, der fuldførte behandlingen i studiet (10 serier), var henholdsvis 29,4 % og.
English: • alteration in sense of taste
Danish: • ændringer i smagssansen
English: Severe hypersensitivity reactions require immediate discontinuation of cabazitaxel and appropriate therapy.
Danish: I tilfælde af svære overfølsomhedsreaktioner skal cabazitaxel seponeres med det samme, og der skal gives passende behandling.
English: This overfill ensures that after dilution with the entire content of the accompanying solvent for JEVTANA, there is a minimal extractable premix volume of 6 ml containing 10 mg/ml JEVTANA which corresponds to the labelled amount of 60 mg per vial.
Danish: Dette overskud sikrer, at der efter fortynding med hele indholdet af det medfølgende hætteglas med solvens til JEVTANA er et mindste ekstraherbart præmiksvolumen på 6 ml indeholdende 10 mg/ml JEVTANA, hvilket svarer til den angivne mængde på 60 mg per hætteglas.
English: The most commonly (≥5%) occurring grade ≥3 adverse reactions in the cabazitaxel group were neutropenia (81.7%), leukopenia (68.2%), anaemia (10.5%), febrile neutropenia (7.5%), diarrhoea
Danish: De mest almindeligt forekommende (≥ 5 %) grad ≥3 bivirkninger i cabazitaxel-gruppen var neutropeni (81,7 %), leukopeni (68,2 %), anæmi (10,5 %), febril neutropeni (7,5 %), diarré 6,2 %).
English: Shelf life and special precautions for storage
Danish: Holdbarhed og særlige forholdsregler for opbevaring
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: There was an improvement in PFS in the JEVTANA arm compared to mitoxantrone arm, 2.8 (2.4-3.0) months versus 1.4 (1.4-1.7) respectively, HR (95%CI) 0.74 (0.64-0.86), p<0.0001.
Danish: Der var en forbedring i PFS i JEVTANA armen sammenlignet med mitoxantron armen, henholdsvis 2,8 (2,4-3,0) måneder versus 1,4 (1,4-1,7), HR (95 %CI) 0,74 (0,64-0,86), p<0,0001.
English: After initial dilution with the entire solvent, each ml of solution contains 10 mg cabazitaxel.
Danish: Efter første fortynding med hele solvensopløsningen indeholder hver ml opløsning 10 mg cabazitaxel.
English: Hypotension Deep vein thrombosis Hypertension Orthostatic hypotension Hot flush Flushing
Danish: Hypotension Dyb venøs trombose Hypertension
English: Grade ≥ 3 adverse reactionsb (%)
Danish: Grad ≥ 3 bivirkningerb (%)
English: Cabazitaxel treatment should be discontinued in case of any degradation of renal function to renal failure ≥CTCAE 4.0 Grade 3.
Danish: Cabazitaxel skal seponeres ved enhver forværring af nyrefunktion til nyresvigt ≥ grad 3 CTCAE v4.0.
English: Package leaflet: Information for the patient JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Danish: Indlægsseddel: Information til brugeren JEVTANA 60 mg koncentrat og solvens til infusionsvæske, opløsning cabazitaxel
English: Delay treatment until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Danish: Udsæt behandlingen, indtil neutrofiltallet er > 1.500 celler/mm3, reducer derpå dosis af cabazitaxel fra 25 mg/m2 til 20 mg/m2.
English: However, if patients require co-administration of a strong CYP3A inhibitor, a 25% cabazitaxel dose reduction should be considered (see sections 4.4 and 4.5).
Danish: Såfremt patienter har behov for samtidig administration af en potent CYP3A-hæmmer, skal 25 % reduktion af cabazitaxeldosis overvejes (se pkt.
English: Table 4 - Overall survival in EFC11785 study in cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm (Intent-to-treat analysis) - Efficacy primary endpoint
Danish: Tabel 4 - Samlet overlevelse i EFC11785-studie med cabazitaxel 25 mg/m2 versus cabazitaxel 20 mg/m2 (Intent to-treat analyse) - Effekt som primære endepunkt CBZ20+PRED n=598
English: Grade ≥ 3 anaemia
Danish: Grad ≥ 3 neutropeni Grad ≥ 3 anæmi Grad ≥ 3 trombocytopeni
English: Cardiac disorders and arrhythmias
Danish: Hjertelidelser og arytmier
English: Dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN), hepatic impairment (see sections 4.2 and 5.2).
Danish: Dosis skal reduceres hos patienter med let nedsat leverfunktion (total-bilirubin >1 til ≤1,5 x ULN eller ASAT > 1,5 x ULN) (se pkt 4.2 og 5.2).
English: JEVTANA should not be used in pregnant women or women of childbearing age not using contraception.
Danish: Gravide kvinder og kvinder i den fødedygtige alder, som ikke bruger prævention, må ikke få JEVTANA.
English: Concentrate-solvent mixture 10 mg/ml
Danish: Koncentrat + solvens- blanding 10 mg/ml
English: Treatment with JEVTANA is contraindicated in patients with severe hepatic impairment (total bilirubin > 3 x ULN) (See sections 4.3 and 5.2).
Danish: Behandling med JEVTANA er kontraindiceret hos patienter med svært nedsat leverfunktion (totalbilirubin >3 x ULN) (se pkt.
English: Chemical and physical stability of the infusion solution has been demonstrated for 8 hours at ambient temperature (including the 1-hour infusion time) and for 48 hours at refrigerated conditions (including the 1-hour infusion time).
Danish: Efter endelig fortynding i infusionsposen/-glasset Kemisk og fysisk stabilitet af infusionsvæsken er blevet påvist i 8 timer ved stuetemperatur (inklusive infusionstiden på 1 time) og i 48 timer ved opbevaring i køleskab (inklusive infusionstiden på 1 time).
English: The incidence of the following grade ≥3 adverse reactions were higher in patients 65 years of age compared to younger patients; neutropenia based on laboratory abnormalities (86.3% versus 73.3%), clinical neutropenia (23.8% versus 16.8%) and febrile neutropenia (8.3% versus 6.1%) (see sections 4.2 and 4.4).
Danish: Forekomsten af følgende bivirkninger af grad ≥3 var højere hos patienter i alderen ≥65 år sammenlignet med yngre patienter: Neutropeni baseret på laboratorieabnormiteter (86,3 % versus 73,3 %), klinisk neutropeni (23,8 % versus 16,8 %) og febril neutropeni (8,3 % versus 6,1 %) (se pkt.
English: Always dilute the concentrate for solution for infusion with the entire supplied solvent before adding to infusion solution.
Danish: Fortynd altid koncentratet til infusionsvæske, opløsning, med hele indholdet af det medfølgende hætteglas med solvens, inden det føjes til en infusionsvæske.
English: METHOD OF ADMINISTRATION Dilute with the ENTIRE supplied solvent.
Danish: Fortyndes med HELE den medfølgende solvens.
English: Dose modifications should be made if patients experience the following adverse reactions (Grades refer to Common Terminology Criteria for Adverse Events [CTCAE 4.0]): Table 1 - Recommended dose modifications for adverse reaction in patients treated with cabazitaxel
Danish: Der bør foretages dosisændringer, hvis patienterne oplever følgende bivirkninger (grader refererer til fælles terminologiske kriterier for bivirkninger [CTCAE v4.0]):
English: The concentrate vial (fill: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (5.67 ml) contain an overfill to compensate for liquid loss during preparation.
Danish: Hætteglasset med koncentrat (påfyldningsvolumen: 73,2 mg cabazitaxel/1,83 ml) og hætteglasset med solvens (påfyldningsvolumen: 5,67 ml) indeholder et overskud for at kompensere for væsketab under præparation.
English: The PSA response was 39.2% in patients on JEVTANA arm (95%CI: 33.9-44.5) versus 17.8% of patients on mitoxantrone (95%CI: 13.7-22.0), p=0.0002.
Danish: PSA respons var 39,2 % hos patienter i JEVTANA-armen (95 % CI: 33,9-44,5) versus 17,8 % hos patienter på mitoxantron (95 % CI: 13,7-22,0) p=0,0002.
English: To limit foaming as much as possible when injecting the solvent, direct the needle onto the inside wall of the vial of concentrate solution and inject slowly.
Danish: Kanylen rettes mod indersiden af hætteglasset med koncentratopløsning og injiceres langsomt for så vidt muligt at undgå skumdannelse.
English: This is very common (may affect more than 1 in 10 people).
Danish: Dette er meget almindeligt (kan påvirke mere end 1 ud af 10 patienter).
English: Cabazitaxel should not be used during breast-feeding.
Danish: Cabazitaxel bør ikke bruges under amning.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 March 2011
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Patients with mild hepatic impairment (total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN), should have cabazitaxel dose reduced to 20 mg/m2.
Danish: Patienter med let nedsat leverfunktion (totalbilirubin >1 til ≤1,5 x øvre normalgrænse (ULN) eller ASAT > 1,5 x ULN) skal have reduceret dosis af cabazitaxel til 20 mg/m2.
English: JEVTANA is contraindicated in patients with severe hepatic impairment (see section 4.3).
Danish: JEVTANA er kontraindiceret til patienter med svært nedsat leverfunktion (se pkt.
English: The adverse reactions reported at rates of at least 5% higher in patients 65 years of age or greater compared to younger patients were diarrhoea (42.9% vs. 32.6%), fatigue (30.2% vs. 19.4%), asthenia (22.4% vs. 13.1%), constipation (20.2% vs. 12.6%), clinical neutropenia (12.9% vs. 6.3%), febrile neutropenia (11.2% vs. 4.6%) and dyspnoea (9.5% vs. 3.4%).
Danish: Bivirkninger, som blev rapporteret med hyppigheder, der var mindst 5% højere hos patienter på 65 år og derover sammenlignet med yngre patienter, var diarré (42,9 % versus 32,6 %), træthed (30,2 % versus 19,4 %), asteni (22,4 % versus 13,1 %), obstipation (20,2 % versus 12,6 %), klinisk neutropeni (12,9 % versus 6,3 %), febril neutropeni (11,2 % versus 4,6 %) og dyspnø (9,5 % versus 3,4 %).
English: Inspect the concentrate vial and the supplied solvent.
Danish: Inspicer hætteglasset med koncentrat og den medfølgende solvens.
English: Hazard Ratioa versus CBZ25+PRED 1-sided 98.89% UCI 1-sided 95% LCI CBZ20=Cabazitaxel 20 mg/m2, CBZ25=Cabazitaxel 25 mg/m2, PRED=Prednisone/Prednisolone CI=confidence interval, LCI=lower bound of the confidence interval, UCI=upper bound of the confidence interval a Hazard ratio is estimated using a Cox Proportional Hazards regression model.
Danish: CBZ20 = Cabazitaxel 20 mg/m2, CBZ25 = Cabazitaxel 25 mg/m2, PRED = Prednison/Prednisolon CI = konfidensinterval, LCI = nedre grænse for konfidensintervallet, UCI = øvre grænse af konfidensintervallet a Hazard ratio er estimeret ved hjælp af en Cox-proportionel-risiko-regressions model.
English: Note: Both the JEVTANA 60 mg/1.5 ml concentrate vial (fill volume: 73.2 mg of cabazitaxel/1.83 ml) and the solvent vial (fill volume: 5.67 ml) contain an overfill to compensate for liquid loss during preparation.
Danish: Bemærk: Både hætteglasset med JEVTANA 60 mg/1,5 ml koncentrat (påfyldningsvolumen: 73,2 mg cabazitaxel/1,83 ml) og hætteglasset med solvens (påfyldningsvolumen: 5,67 ml) indeholder et overskud for at kompensere for væsketab under præparation.
English: • feeling of numbness, tingling, burning or decreased sensations in hands and feet
Danish: • følelsesløshed, prikkende eller brændende fornemmelse eller nedsat følelse i hænder og fødder
English: • mental confusion
Danish: • sindsforvirring
English: There was a significant higher rate of tumour response of 14.4% (95%CI: 9.6-19.3) in patients in the JEVTANA arm compared to 4.4% (95%CI: 1.6-7.2) for patients in the mitoxantrone arm, p=0.0005.
Danish: Der var en signifikant højere tumor respons på 14,4 % (95 % CI: 9,6-19,3) hos patienter i JEVTANA-armen sammenlignet med 4,4 % (95 % CI: 1,6-7,2) hos patienter i mitoxantron-armen, p=0,0005.
English: Do not use PVC infusion containers or polyurethane infusion sets for the preparation and administration of JEVTANA.
Danish: PVC-infusionsbeholdere eller infusionssæt af polyurethan må ikke anvendes til klargøring og administration af JEVTANA.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4.5 ml (ethanol 96% and water for injections).
Danish: 4,5 ml (ethanol 96 % og vand til injektionsvæsker).
English: How to store JEVTANA
Danish: SOLVENS til JEVTANA
English: Each vial of 1.5 ml (nominal volume) of concentrate contains 60 mg cabazitaxel.
Danish: Hvert 1,5 ml (nominelt volumen) hætteglas med koncentrat indeholder 60 mg cabazitaxel.
English: Aseptically withdraw the required amount of concentrate-solvent mixture (10 mg/ml of cabazitaxel), with a graduated syringe fitted with a needle.
Danish: Det nødvendige volumen af koncentrat + solvens-blandingen (10 mg cabazitaxel per ml) udtrækkes aseptisk med en gradueret sprøjte med påsat kanyle.
English: • urinary incontinence
Danish: • urininkontinens