FrancophonIA/ELRC3.0 huggingface dataset:
English: Kyprolis treatment was administered for a maximum of 18 cycles unless discontinued early for disease progression or unacceptable toxicity.
Danish: Kyprolis blev administreret i maksimalt 18 cyklusser, medmindre det blev seponeret på et tidligere tidspunkt på grund af sygdomsprogression eller uacceptabel toksicitet.
English: The effect of carfilzomib on cardiac repolarisation using the QT interval with Fridericia's correction (QTcF interval) and the analysis of concentration-QTc relationships show no clear signal of any dose-related effect.
Danish: Undersøgelse af carfilzomibs virkning på hjertets repolarisering ved anvendelse af QT-intervallet med Fridericias korrektion (QTcF-intervallet) og analyse af sammenhængen mellem koncentration og QTc viste ingen tydelige tegn på en dosisrelateret virkning.
English: If you have ever had hepatitis B infection, treatment with this medicine may cause the hepatitis B infection to become active again.
Danish: Hvis du på noget tidspunkt har haft hepatitis B-infektion, kan behandlingen med dette lægemiddel reaktivere hepatitis B-infektionen
English: Therefore, resumption of therapy should be discussed with experts in managing HBV.
Danish: Derfor skal genoptagelse af behandlingen drøftes med læger med ekspertise i behandling af HBV.
English: Thromboprophylaxis should be considered based on an individual benefit/risk assessment.
Danish: Tromboprofylakse bør overvejes ud fra en individuel vurdering af fordele/risici.
English: Study PX-171-011 was an open-label randomised phase 3 study (N = 315; exposure to ≥ 3 prior therapies required).
Danish: Studie PX-171-011 var et åbent, randomiseret fase 3-studie (N = 315; eksponering for ≥ 3 tidligere behandlinger påkrævet).
English: • Changes to blood tests (decreased blood levels of potassium, increased blood levels of sugar and/or creatinine)
Danish: • Ændringer i blodprøver (lave niveauer af kalium i blodet, forhøjede niveauer af sukker og/eller kreatinin i blodet)
English: • Creatinine clearance < 15 mL/min (or creatinine clearance decreases to ≤ 50% of baseline) or need for dialysis (see section 4.4)
Danish: • Kreatininclearance < 15 ml/min (eller kreatininclearance falder til ≤ 50 % af baseline) eller behov for dialyse (se pkt.
English: • Infection of the stomach and intestine (gastroenteritis)
Danish: • Infektion i mave og tarme (gastroenteritis)
English: Hypertension including hypertensive crises
Danish: Hypertension, herunder hypertensiv krise
English: Lenalidomide and dexamethasone administration could continue until progression or unacceptable toxicity.
Danish: Administration af lenalidomid og dexamethason kunne fortsætte indtil sygdomsprogression eller uacceptabel toksicitet.
English: However, if you are given too much Kyprolis your doctor will monitor you for side effects.
Danish: Hvis du alligevel får for meget Kyprolis, vil din læge holde øje med, om du eventuelt får bivirkninger.
English: Gently swirl and/or invert the vial slowly for approximately 1 minute, or until complete dissolution.
Danish: Skvulp forsigtigt hætteglasset og/eller vend det langsomt på hovedet i ca. 1 minut, eller indtil pulveret er helt opløst.
English: You must look out for certain symptoms while you are taking Kyprolis to reduce the risk of any problems.
Danish: Mens du får Kyprolis, er der visse symptomer, du skal holde øje med for at nedsætte risikoen for eventuelle problemer.
English: Patients enrolled to study PX-171-011 were more heavily pre-treated with lower organ and marrow function as compared to those enrolled in study PX-171-009.
Danish: De patienter, der deltog i studie PX-171-011, havde tidligere fået mere intens behandling og havde dårligere organ- og marvfunktion sammenlignet med patienter, der deltog i studie PX-171-009.
English: Dexamethasone should be administered prior to Kyprolis to reduce the incidence and severity of reactions (see section 4.2).
Danish: Dexamethason skal administreres inden Kyprolis for at reducere forekomsten og sværhedsgraden af disse reaktioner (se pkt.
English: • Stop dose and continue monitoring renal function (serum creatinine or creatinine clearance) Kyprolis should be resumed when renal function has recovered to within 25% of baseline; consider resuming at 1 dose level reductiona
Danish: • Stop dosering og fortsæt med monitorering af nyrefunktion (serumkreatinin eller kreatininclearance) Kyprolis skal genoptages, når nyrefunktionen er bedret til inden for 25 % af baseline; overvej genoptagelse med 1 dosisniveaureduktiona
English: This may impair your ability to drive or operate machines.
Danish: Dette kan nedsætte din evne til at føre motorkøretøj og betjene maskiner.
English: The predominant metabolites measured in human plasma and urine, and generated in vitro by human hepatocytes, were peptide fragments and the diol of carfilzomib, suggesting that peptidase cleavage and epoxide hydrolysis were the principal pathways of metabolism.
Danish: De vigtigste metabolitter, der er målt i humant plasma og urin og dannet in vitro af humane hepatocytter, var peptidfragmenter og diolet af carfilzomib, hvilket tyder på, at peptidasespaltning og epoxidhydrolase er de vigtigste metaboliseringsveje.
English: • Liver problems including an increase in liver enzymes in the blood
Danish: • Leverproblemer, herunder forhøjede leverenzymer i blodet
English: Give an additional 250 mL to 500 mL of intravenous fluids as needed following Kyprolis administration in cycle 1.
Danish: Der gives yderligere 250-500 ml intravenøs væske efter behov efter administration af Kyprolis i cyklus 1.
English: • Numbness, tingling, or decreased sensation in hands and/or feet
Danish: • Følelsesløshed, prikken eller nedsat følesans i hænder og/eller fødder
English: Creatinine clearance was stable over time for the majority of patients.
Danish: Hos størstedelen af patienterne var kreatininclearance stabil over tid.
English: On the basis of the scientific conclusions for carfilzomib the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing carfilzomib is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for carfilzomib er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder carfilzomib, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: The systemic clearance ranged from 151 to 263 L/hour, and exceeded hepatic blood flow, suggesting that carfilzomib was largely cleared extrahepatically.
Danish: Den systemiske clearance lå i intervallet 151 til 263 l/timen og var større end blodgennemstrømningen i leveren, hvilket tyder på, at carfilzomib overvejende fjernes uden for leveren.
English: Caution should be used in the concomitant administration of other agents that may increase the risk of thrombosis (e.g. erythropoietic agents or hormone replacement therapy).
Danish: Der skal udvises forsigtighed i forbindelse med samtidig administration af andre midler, som kan forhøje risikoen for trombose (fx erytropoietiske midler eller hormonsubstitutionsbehandling).
English: Read the complete preparation instructions prior to reconstitution.
Danish: Gennemlæs alle anvisninger til klargøring af præparatet inden rekonstitution.
English: In vitro studies indicated that carfilzomib did not induce human CYP3A4 in cultured human hepatocytes.
Danish: In vitro studier indikerer, at carfilzomib ikke inducerer human CYP3A4 i dyrkede humane hepatocytter.
English: 25 mg daily a. Infusion time is 10 minutes and remains consistent throughout the regimen
Danish: 25 mg dagligt a. Infusionstiden er 10 minutter og forbliver den samme under hele behandlingen
English: Fertility studies with carfilzomib have not been conducted.
Danish: Der er ikke udført fertilitetsstudier med carfilzomib.
English: Following repeated doses of Kyprolis at 15 and 20 mg/m2, systemic exposure (AUC) and half-life were similar on days 1 and 15 or 16 of cycle 1, suggesting there was no systemic carfilzomib accumulation.
Danish: Efter gentagne doser Kyprolis på 15 og 20 mg/m2 var den systemiske eksponering (AUC) og halveringstid sammenlignelige på dag 1 og 15 eller 16 i cyklus 1, hvilket tyder på, at der ikke er nogen systemisk akkumulering af carfilzomib.
English: From cycle 13, the day 8 and 9 doses of Kyprolis are omitted.
Danish: Fra cyklus 13 udelades doserne af Kyprolis på dag 8 og 9.
English: While you are being treated with Kyprolis you may experience fatigue, dizziness, fainting, and/or a drop in blood pressure.
Danish: Mens du behandles med Kyprolis, kan du blive træt, svimmel, besvime og/eller opleve, at dit blodtryk falder.
English: Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes.
Danish: Fortæl det straks til din læge, hvis du bliver mere træt end normalt, eller hvis din hud eller det hvide i dine øjne bliver gult.
English: However, it is unknown whether carfilzomib is an inducer of CYP1A2, 2C8, 2C9, 2C19 and 2B6 at therapeutic concentrations.
Danish: Det vides dog ikke, om carfilzomib er induktor af CYP1A2, 2C8, 2C9, 2C19 og 2B6 i terapeutiske koncentrationer.
English: Proportion Surviving
Danish: Andel overlevende
English: The median OS improved by 7.9 months in patients in the KRd arm compared with those in the Rd arm (see Table 6 and Figure 2).
Danish: Median-OS blev forbedret med 7,9 måneder for patienter i KRd-armen sammenlignet med patienterne i Rd-armen (se tabel 6 og figur 2).
English: The highest non-severely toxic dose of 0.5 mg/kg in monkeys resulted in interstitial inflammation in the kidney along with slight glomerulopathy and slight heart inflammation.
Danish: Den højeste ikke-alvorligt toksiske dosis på 0,5 mg/kg til aber medførte interstitiel inflammation i nyrerne sammen med let glomerulopati og let kardiel inflammation.
English: • Blood clots in the veins (deep vein thrombosis)
Danish: • Blodpropper i venerne (dyb venetrombose)
English: Platelet counts should be monitored frequently during treatment with Kyprolis.
Danish: Trombocyttallet skal kontrolleres hyppigt under behandling med Kyprolis.
English: Kyprolis will be given as an infusion into a vein.
Danish: Kyprolis vil blive givet som infusion i en vene.
English: While taking Kyprolis, and for 30 days after stopping treatment you should use a suitable method of contraception to ensure you do not become pregnant.
Danish: Mens du får Kyprolis og i 30 dage efter behandlingens ophør, skal du bruge en egnet præventionsform for at sikre, at du ikke bliver gravid.
English: Dexamethasone (mg)
Danish: Dexamethason (mg)
English: For potential dose-related effects, see section 4.8.
Danish: For potentielle dosisrelaterede virkninger, se pkt.
English: Combination dosing with lenalidomide and dexamethasone did not affect proteasome inhibition.
Danish: Kombinationsbehandling med lenalidomid og dexamethason påvirkede ikke proteasomhæmningen.
English: Progressive Multifocal Leukoencephalopathy
Danish: Progressiv multifokal leukoencefalopati
English: a. Infusion time is 30 minutes and remains consistent throughout the regimen
Danish: a. Infusionstiden er 30 minutter og forbliver den samme under hele behandlingen
English: Increased blood creatinine
Danish: Forhøjet blodkreatinin
English: Kyprolis is a medicine that contains the active substance carfilzomib.
Danish: Kyprolis er et lægemiddel, som indeholder det aktive stof carfilzomib.
English: Carfilzomib is a tetrapeptide epoxyketone proteasome inhibitor that selectively and irreversibly binds to the N terminal threonine containing active sites of the 20S proteasome, the proteolytic core particle within the 26S proteasome, and displays little to no activity against other protease classes.
Danish: Carfilzomib er en tetrapeptid-epoxyketonproteasom-hæmmer, der binder selektivt og irreversibelt til de N-terminale treonin-holdige aktive steder på 20S-proteasomet, den proteolytiske kernepartikel i 26S-proteasomet, og udviser kun lidt eller slet ingen aktivitet mod andre proteaseklasser.
English: Since dialysis clearance of Kyprolis concentrations has not been studied, the medicinal product should be administered after the dialysis procedure.
Danish: Da clearance af Kyprolis ved dialyse ikke er undersøgt, skal lægemidlet administreres efter dialyse.
English: Carfilzomib does not inhibit human UGT2B7 but inhibits human UGT1A1 with an IC50 of 5.5 µM.
Danish: Carfilzomib hæmmer ikke human UGT2B7, men hæmmer human UGT1A1 med en IC50 på 5,5 µM.
English: At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion.
Danish: Når som helst under eller efter din behandling skal du straks fortælle det til lægen eller sygeplejersken, hvis du oplever sløret syn, synstab eller dobbeltsyn, talebesvær, svækkelse i en arm eller et ben, en ændring i den måde, du går på, eller problemer med balanceevnen, vedvarende følelsesløshed, nedsat følesans eller tab af følesans, hukommelsestab eller forvirring.
English: • Liver problems, including a history of hepatitis, fatty liver, or if you have ever been told your liver is not working properly
Danish: • Leverproblemer, herunder tidligere tilfælde af hepatitis, fedtlever, eller hvis du nogensinde har fået at vide, at din lever ikke fungerer godt nok
English: Kyprolis is to be administered by intravenous infusion.
Danish: Kyprolis skal administreres ved intravenøs infusion.
English: Recommended hydration includes both oral fluids (30 mL/kg/day for 48 hours before day 1 of cycle 1) and intravenous fluids (250 mL to 500 mL of appropriate intravenous fluid before each dose in cycle 1).
Danish: Den anbefalede hydrering omfatter både orale væsker (30 ml/kg/dag i 48 timer inden dag 1 i cyklus 1) og intravenøse væsker (250-500 ml passende intravenøs væske før hver dosis i cyklus 1).
English: Clostridium difficile colitis Cytomegalovirus infection Hepatitis B virus reactivation
Danish: Clostridium difficile-colitis Cytomegalovirusinfektion Reaktivering af hepatitis B-virus
English: Proteasome inhibition was maintained for ≥ 48 hours following the first dose of carfilzomib for each week of dosing.
Danish: Proteasomhæmning blev opretholdt i ≥ 48 timer efter den første dosis carfilzomib i hver behandlingsuge.
English: No clinical trial was conducted with a dose of 56 mg/m2.
Danish: Der er ikke udført kliniske studier med en dosis på 56 mg/m2.
English: What you need to know before you use Kyprolis
Danish: Det skal du vide, før du begynder at bruge Kyprolis
English: PX-171-003A1 was a single-arm phase 2 study (N = 266; exposure to ≥ 2 prior therapies required), which met its primary efficacy endpoint of IRC-assessed ORR (22.9%).
Danish: PX-171-003A1 var et fase 2-studie med en enkelt behandlingsarm (N = 266; eksponering for ≥ 2 tidligere behandlinger påkrævet), der opfyldte det primære effektendemål: IRC-vurderet ORR (22,9 %).
English: This means that Kyprolis will be given to you on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle.
Danish: Det betyder, at du vil få Kyprolis på dag 1, 2, 8, 9, 15 og 16 i hver 28-dages cyklus.
English: Death due to cardiac arrest has occurred within a day of Kyprolis administration and fatal outcomes have been reported with cardiac failure and myocardial infarction.
Danish: Død som følge af hjertestop er forekommet inden for en dag efter administration af Kyprolis, og der er indberettet dødelige tilfælde af hjerteinsufficiens og myokardieinfarkt.
English: A number of cases of Hepatitis B reactivation have been identified in relation to carfilzomib treatment.
Danish: Der er identificeret et antal tilfælde af reaktivering af hepatitis B i forbindelse med behandling med carfilzomib.
English: Your doctor or nurse will check if you are getting enough fluids.
Danish: Lægen eller sundhedspersonalet vil kontrollere, at du får tilstrækkelig med væske.
English: These included 1 well-documented serious case of hepatitis B reactivation with a likely association with carfilzomib and no substantial confounders, and 1 case of hepatitis B reactivation suggestive of a causal association which developed with the addition of carfilzomib to an ongoing regimen of lenalidomide plus dexamethasone, as well as 20 other serious cases which had, at minimum, a plausible temporal association with carfilzomib.
Danish: Disse omfattede 1 veldokumenteret alvorligt tilfælde af reaktivering af hepatitis B med en sandsynlig sammenhæng med carfilzomib og ingen væsentlige konfoundere, 1 tilfælde af reaktivering af hepatitis B, der tydede på en kausal sammenhæng, som udvikledes ved tillæg af carfilzomib til en igangværende behandling med lenalidomid plus dexamethason, samt 20 andre alvorlige tilfælde, der som minimum havde en plausibel tidsmæssig sammenhæng med carfilzomib.
English: If PML is confirmed, carfilzomib must be discontinued.
Danish: Hvis PML bekræftes, skal behandling med carfilzomib seponeres.
English: PX-171-011 evaluated Kyprolis monotherapy versus a control arm (corticosteroids and cyclophosphamide).
Danish: I PX-171-011 blev monoterapi med Kyprolis sammenlignet med en kontrolarm (kortikosteroider og cyclophosphamid).
English: Hepatitis B Virus (HBV) Reactivation
Danish: Reaktivering af hepatitis B-virus (HBV)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Kyprolis in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Kyprolis i alle undergrupper af den pædiatriske population med myelomatose (se pkt.
English: Kyprolis powder for solution for infusion must not be mixed with sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Kyprolis pulver til infusionsvæske, opløsning, må ikke blandes med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske.
English: The reconstituted solution contains carfilzomib at a concentration of 2 mg/mL.
Danish: Den rekonstituerede infusionsvæske indeholder carfilzomib i en koncentration på 2 mg/ml.
English: • Low red blood cell count (anaemia) which may cause tiredness and fatigue
Danish: • Lavt antal røde blodlegemer (anæmi), som kan medføre træthed og udmattelse
English: Patients randomised to the Vd arm could receive bortezomib either by the intravenous (n = 108) or subcutaneous (n = 357) route.
Danish: Patienter, der var randomiseret til Vd-armen, kunne få bortezomib enten som intravenøs (n = 108) eller subkutan (n = 357) administration.
English: • Changes to blood tests (decreased blood levels of sodium, magnesium, protein, calcium or phosphate, increased blood levels of calcium, uric acid, potassium, bilirubin or c-reactive protein)
Danish: • Ændringer i blodprøver (reducerede niveauer af natrium, magnesium, protein, calcium eller fosfat i blodet, forhøjede niveauer af calcium, urinsyre, kalium, bilirubin eller C-reaktivt protein i blodet)
English: • Pain, swelling, irritation or discomfort where you received the injection into your vein
Danish: • Smerter, hævelse, irritation eller ubehag på det sted, hvor du har fået infusionen
English: Months from Randomisation
Danish: Måneder efter randomisering
English: • Heart problems, including a history of chest pain (angina), heart attack, irregular heartbeat, high blood pressure or if you have ever taken a medicine for your heart
Danish: • Hjerteproblemer, herunder tidligere tilfælde af brystsmerter (angina), hjerteanfald, uregelmæssig hjerterytme, forhøjet blodtryk, eller hvis du nogensinde har fået hjertemedicin
English: Kaplan-Meier plot of progression-free survival as determined by the IRC (intent-to-treat population) study 2011-003
Danish: Kaplan-Meier-kurve over den progressionsfrie overlevelse, fastlagt af IRC (intent-to-treat-population), studie 2011-003
English: The 20/56 mg/m2 dose must be administered over 30 minutes.
Danish: 20/56 mg/m2 dosen skal administreres over 30 minutter.
English: In the second study, the exposures for M14 were greater (approximately 4-fold) in subjects with ESRD than in subjects with normal renal function.
Danish: I det andet studie var eksponeringerne for M14 højere (cirka 4 gange) hos patienter med ESRD end hos patienter med normal nyrefunktion.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, haemoptysis, arm or leg swelling or pain.
Danish: Patienterne skal anmodes om at søge læge, hvis de får symptomer, som for eksempel stakåndethed, brystsmerter, hæmoptyse eller hævelser eller smerter i arme eller ben.
English: However, given that Kyprolis is administrated intravenously and is extensively metabolised, the pharmacokinetic profile of carfilzomib is unlikely to be affected by P-gp or BCRP inhibitors or inducers.
Danish: Da Kyprolis administreres intravenøst og metaboliseres i omfattende udstrækning, er det imidlertid usandsynligt, at carfilzomibs farmakokinetiske profil påvirkes af P-gp- eller BCRP-hæmmere eller -induktorer.
English: The doses on day 8 and 9 of each cycle will not be given from cycle 13 onwards if you are treated with Kyprolis in combination with lenalidomide and dexamethasone.
Danish: Fra og med cyklus 13 vil du ikke få doserne på dag 8 og 9, hvis du behandles med Kyprolis i kombination med lenalidomid og dexamethason.
English: The safety of reinitiating Kyprolis therapy in patients previously experiencing TTP/HUS is not known.
Danish: Sikkerheden ved reinitiering af Kyprolis hos patienter, der tidligere har haft TTP/HUS, kendes ikke.
English: While adequate hydration is required prior to dosing in cycle 1, all patients should be monitored for evidence of volume overload, especially patients at risk for cardiac failure.
Danish: Selvom adækvat hydrering er et krav inden dosering i cyklus 1, skal alle patienter monitoreres for tegn på volumenoverbelastning, især patienter med risiko for hjerteinsufficiens.
English: Cases of hepatic failure, including fatal cases, have been reported in < 1% of subjects in clinical studies with Kyprolis.
Danish: Der er rapporteret tilfælde af leverinsufficiens, herunder dødelige tilfælde, hos < 1 % af patienterne i kliniske studier med Kyprolis.
English: Increased alanine aminotransferase Increased aspartate aminotransferase Gammaglutamyltransferase increased
Danish: Forhøjet alaninaminotransferase Forhøjet aspartataminotransferase Forhøjet gammaglutamyltransferase Hyperbilirubinæmi
English: The 20/27 mg/m2 dose is administered over 10 minutes.
Danish: 20/27 mg/m2 dosen administreres over 10 minutter.
English: A total of 929 patients with relapsed or refractory multiple myeloma who had received 1 to 3 prior lines of therapy were enrolled and randomised (464 in the Kd arm; 465 in the Vd arm).
Danish: I alt 929 patienter med recidiveret eller refraktær myelomatose, der havde fået 1 til 3 tidligere behandlingsforløb, blev inkluderet og randomiseret (464 i Kd-armen og 465 i Vd-armen).
English: In vitro, at concentrations (3 µM) lower than those expected at therapeutic doses, carfilzomib inhibits the efflux transport of digoxin, a P-gp substrate, by 25%.
Danish: Ved koncentrationer (3 µM) lavere end dem, der forventes ved terapeutiske doser, hæmmer carfilzomib in vitro effluxtransporten af digoxin, et P-gp-substrat, med 25 %.
English: Instructions for reconstitution and preparation of Kyprolis powder for solution for infusion for intravenous administration
Danish: Instruktioner til rekonstitution og klargøring af Kyprolis pulver til infusionsvæske, opløsning, til intravenøs administration
English: Following intravenous administration of doses ≥ 15 mg/m2, carfilzomib was rapidly cleared from the systemic circulation with a half-life of ≤ 1 hour on day 1 of cycle 1.
Danish: Efter intravenøs administration af doser ≥ 15 mg/m2 blev carfilzomib hurtigt fjernet fra det systemiske kredsløb med en halveringstid på ≤ 1 time på dag 1 i cyklus 1.