FrancophonIA/ELRC3.0 huggingface dataset:
English: As Kyprolis is administered in combination with other medicinal products, the summary of product characteristics of these other medicinal products must be consulted prior to initiation of treatment with Kyprolis.
Danish: Da Kyprolis administreres i kombination med andre lægemidler, skal man være opmærksom på disse andre lægemidlers produktresuméer, inden behandling med Kyprolis iværksættes.
English: If the diagnosis is suspected, stop Kyprolis and evaluate patients for possible TTP/HUS.
Danish: Ved mistanke om denne diagnose stoppes behandlingen med Kyprolis, og patienten evalueres for eventuel TTP/HUS.
English: Treatment with Kyprolis combined with lenalidomide and dexamethasone for longer than 18 cycles should be based on an individual benefit/risk assessment, as the data on the tolerability and toxicity of carfilzomib beyond 18 cycles are limited (see section 5.1).
Danish: Behandling med Kyprolis kombineret med lenalidomid og dexamethason i mere end 18 cyklusser skal baseres på en individuel vurdering af fordele kontra risici, da der er begrænsede data vedrørende carfilzomibs tolerabilitet og toksicitet efter 18 cyklusser (se pkt.
English: Thromboprophylaxis is recommended in patients being treated with Kyprolis in combination with dexamethasone or with lenalidomide and dexamethasone, and should be based on an assessment of the patient's underlying risks and clinical status.
Danish: Tromboseprofylakse anbefales til patienter, der behandles med Kyprolis i kombination med dexamethason eller med lenalidomid og dexamethason, og skal baseres på en vurdering af patientens underliggende risici og kliniske status.
English: • Febrile neutropenia
Danish: • Febril neutropeni
English: The dose is calculated using the patient's baseline body surface area (BSA).
Danish: Dosis beregnes ved hjælp af patientens legemsoverfladeareal (BSA) ved baseline.
English: Deep vein thrombosis Hypotension Flushing
Danish: Dyb venetrombose Hypotension Flushing
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning hos patienter, der er på en natriumreduceret diæt.
English: • A blockage in the flow of bile from the liver (cholestasis), which can cause itchy skin, yellow skin, very dark urine and very pale stools
Danish: • Blokering af galdestrømmen fra leveren (kolestase), hvilket kan give hudkløe, gullig hud, meget mørk urin og meget lys afføring
English: Carfilzomib was rapidly and extensively metabolised.
Danish: Carfilzomib metaboliseres hurtigt og i vid udstrækning.
English: The intravenous administration line should be flushed with normal sodium chloride solution or 5% glucose solution for injection immediately before and after Kyprolis administration.
Danish: Infusionsslangen skal skylles med en isotonisk natriumchloridinjektionsvæske eller 5 % glucoseinjektionsvæske umiddelbart inden og efter administration af Kyprolis.
English: The conditions of the Pregnancy Prevention Programme for lenalidomide must be fulfilled for all patients unless there is reliable evidence that the patient does not have child bearing potential.
Danish: Alle patienter skal opfylde betingelserne i graviditetsforebyggelsesprogrammet for lenalidomid, medmindre det er påviseligt, at patienten ikke er fertil.
English: Caution should be observed when carfilzomib is combined with substrates of P-gp (e.g. digoxin, colchicine).
Danish: Der skal udvises forsigtighed, hvis carfilzomib kombineres med substrater for P-gp (fx digoxin, colchicin).
English: • High blood pressure (hypertension)
Danish: • Højt blodtryk (hypertension)
English: Doses of ≥ 15 mg/m2 consistently induced an (≥ 80%) inhibition of the CT-L activity of the proteasome.
Danish: Carfilzomibdoser ≥ 15 mg/m2 medførte konsekvent en (≥ 80 %) hæmning af proteasomets CT-L-aktivitet.
English: • Absolute neutrophil count < 0.5 x 109/L (see section 4.4)
Danish: • Absolut neutrofiltal < 0,5 x 109/l (se pkt.
English: Thus, there are limited data for Kyprolis in combination with lenalidomide and dexamethasone in patients with creatinine clearance (CrCL < 50 mL/min).
Danish: Der findes således kun begrænsede data for Kyprolis i kombination med lenalidomid og dexamethason hos patienter med kreatininclearance (CrCL) < 50 ml/min.
English: Talk to your doctor or nurse before using Kyprolis if you have any of the conditions listed below.
Danish: Kontakt lægen eller sundhedspersonalet, før du bruger Kyprolis, hvis du har en eller flere af nedenstående tilstande.
English: Reduce or stop dose as appropriate (see section 4.2).
Danish: Reducér dosis eller stop behandlingen efter behov (se pkt.
English: Patients being treated with Kyprolis should be advised not to drive or operate machines in the event that they experience any of these symptoms.
Danish: Patienter, der behandles med Kyprolis, skal frarådes at føre motorkøretøj og betjene maskiner, hvis de får disse symptomer.
English: Thrombocytopenia was reported in approximately 34% of subjects in clinical studies with Kyprolis and approximately 20% of subjects had grade ≥ 3 events.
Danish: Der blev rapporteret trombocytopeni hos ca. 34 % af patienterne i kliniske studier med Kyprolis, og ca. 20 % af patienterne havde hændelser grad ≥ 3.
English: The safety and efficacy of Kyprolis were evaluated in a phase 3, randomised, open-label, multicentre study of Kyprolis plus dexamethasone (Kd) versus bortezomib plus dexamethasone (Vd).
Danish: Kyprolis' sikkerhed og effekt blev undersøgt i et randomiseret, åbent fase 3-multicenterstudie med Kyprolis plus dexamethason (Kd) vs. bortezomib plus dexamethason (Vd).
English: Carfilzomib administered to pregnant rats during the period of organogenesis was not teratogenic at doses up to 2 mg/kg/day, which is approximately half the recommended dose in humans of 27 mg/m2 based on BSA.
Danish: Carfilzomib, der blev administreret til drægtige rotter under organogenesen, var ikke teratogent ved doser på op til 2 mg/kg/dag, hvilket svarer til ca. halvdelen af den anbefalede humane dosis på 27 mg/m2 baseret på BSA.
English: It cannot be excluded that the efficacy of oral contraceptives may be reduced during carfilzomib treatment (see section 4.5).
Danish: Det kan ikke udelukkes, at effekten af orale kontraceptiva kan være nedsat under behandling med carfilzomib (se pkt.
English: In clinical studies, hypertension adverse events occurred in approximately 20% of subjects and 7.5% of subjects had grade ≥ 3 hypertension events, but hypertensive crises occurred in < 0.5% of subjects.
Danish: I kliniske studier opstod hypertension hos ca. 20 % af patienterne, og 7,5 % af patienterne havde hypertension grad ≥ 3, mens der opstod hypertensiv krise hos < 0,5 % af patienterne.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: sometimes spreading across to the neck and shoulders, sometimes with a fever
Danish: Symptomerne omfatter smerter bag brystbenet, der sommetider breder sig til hals og skuldre, og sommetider er ledsaget af feber
English: Kyprolis contains sodium
Danish: Kyprolis indeholder natrium
English: Kyprolis vials contain no antimicrobial preservatives and are intended for single use only.
Danish: Hætteglassene med Kyprolis indeholder ingen antimikrobielle konserveringsmidler og er kun beregnet til engangsbrug.
English: Adequate hydration is required before dose administration in cycle 1, especially in patients at high risk of tumour lysis syndrome or renal toxicity.
Danish: Adækvat hydrering er nødvendig inden administration af doser i cyklus 1, især hos patienter, der har stor risiko for tumorlysesyndrom eller nyretoksicitet.
English: There are limited efficacy and safety data on patients with baseline creatinine clearance < 30 mL/min.
Danish: Der er kun begrænsede data vedrørende virkning og sikkerhed hos patienter med kreatininclearance < 30 ml/min ved baseline.
English: Carfilzomib is a cytotoxic agent.
Danish: Carfilzomib er et cytotoksisk stof.
English: As lenalidomide may be used in combination with Kyprolis, particular attention to the lenalidomide pregnancy testing and prevention requirements is needed (see section 4.6).
Danish: Da lenalidomid kan blive brugt i kombination med Kyprolis, skal man være særligt opmærksom på kravene til graviditetstest og kontraception ved lenalidomid (se pkt.
English: If your partner becomes pregnant whilst you are taking Kyprolis or within 90 days after stopping treatment, notify your doctor or nurse immediately.
Danish: Hvis din partner bliver gravid, mens du får Kyprolis eller inden for 90 dage efter behandlingens ophør, skal du straks informere lægen eller sundhedspersonalet om det.
English: Do not mix Kyprolis with or administer as an infusion with other medicinal products.
Danish: Kyprolis må ikke blandes med andre lægemidler eller administreres som infusion med andre lægemidler.
English: If tolerated, patients received 56 mg/m2 starting in cycle 2.
Danish: Hvis dette blev tolereret, startede patienterne med 56 mg/m2 i cyklus 2.
English: In clinical studies with Kyprolis, cardiac toxicity and dyspnoea typically occurred early in the course of Kyprolis therapy (see section 4.4).
Danish: I kliniske studier med Kyprolis opstod kardiel toksicitet og dyspnø typisk i det tidlige behandlingsforløb (se pkt.
English: • Kidney problems, including kidney failure or if you have ever received dialysis
Danish: • Nyreproblemer, herunder nyresvigt, eller hvis du nogensinde har været i dialyse
English: Kyprolis, as a single agent, was administered intravenously over 2 to 10 minutes at doses up to 20 mg/m2.
Danish: Kyprolis som enkeltstof blev administreret intravenøst over 2-10 minutter i doser på op til 20 mg/m2.
English: Dyspnoea was reported in approximately 30% of subjects in clinical studies with Kyprolis.
Danish: Der blev rapporteret dyspnø hos ca. 30 % af patienterne i kliniske studier med Kyprolis.
English: In clinical studies with Kyprolis, cardiac failure was reported in approximately 7% of subjects (5% of subjects had grade ≥ 3 events), myocardial infarction was reported in approximately 2% of subjects (1.5% of subjects had grade ≥ 3 events) and myocardial ischaemia was reported in approximately 1% of subjects (< 1% of subjects had grade ≥ 3 events).
Danish: I kliniske studier med Kyprolis blev hjerteinsufficiens rapporteret hos ca. 7 % af patienterne (5 % af patienterne havde hændelser grad ≥ 3), myokardieinfarkt blev rapporteret hos ca. 2 % af patienterne (1,5 % af patienterne havde hændelser grad ≥ 3), og myokardieiskæmi blev rapporteret hos ca. 1 % af patienterne (< 1 % af patienterne havde hændelser grad ≥ 3).
English: Very common side effects (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (kan optræde hos flere end 1 ud af 10 personer)
English: At the higher dose of 56 mg/m2, there was not only a greater inhibition of CT-L subunits (≥ 90%) compared to those at 15 to 20 mg/m2, but also a greater inhibition of other proteasome subunits (LMP7, MECL1, and LMP2).
Danish: Ved den høje dosis på 56 mg/m2 var der ikke blot en øget hæmning af CT-L-delenheder (≥ 90 %) sammenlignet med doser på 15 til 20 mg/m2, men også en øget hæmning af andre proteasom-delenheder (LMP7, MECL1 og LMP2).
English: • Lung problems, including a history of shortness of breath at rest or with activity (dyspnoea)
Danish: • Lungeproblemer, herunder tidligere tilfælde af stakåndethed i hvile eller i forbindelse med aktivitet (dyspnø)
English: In the first study the M14 metabolite, a peptide fragment and the most abundant circulating metabolite, increased 2- and 3-fold in patients with moderate and severe renal impairment, respectively, and 7-fold in patients requiring dialysis (based on AUClast).
Danish: I det første studie steg eksponeringen for M14-metabolitten - et peptidfragment og den væsentligste cirkulerende metabolit, 2 og 3 gange hos patienter med henholdsvis moderat og svært nedsat nyrefunktion og 7 gange hos patienter med behov for dialyse (baseret på AUClast).
English: Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Danish: Det er kendt, at thalidomid er teratogent hos mennesker og forårsager alvorlige, livstruende medfødte misdannelser.
English: In animals, carfilzomib inhibited proteasome activity in blood and tissue and delayed tumour growth in models of multiple myeloma.
Danish: Hos dyr hæmmede carfilzomib proteasom-aktiviteten i blod og væv og forsinkede tumorvæksten i myelomatosemodeller.
English: Study eligibility criteria allowed a small subset of patients with myeloma refractory to bortezomib (n = 118) or lenalidomide (n = 57) to be enrolled.
Danish: Studiets kriterier for egnethed tillod, at en lille delgruppe af patienter med myelom, som var refraktært over for bortezomib (n = 118) eller lenalidomid (n = 57), kunne deltage.
English: The study did not meet its primary efficacy endpoint of demonstrating superiority of Kyprolis monotherapy over the active control arm in overall survival (HR = 0.975 [95% CI: 0.760-1.249]).
Danish: Studiet nåede ikke det primære effektendemål: påvisning af Kyprolis' superioritet som monoterapi i forhold til den aktive kontrolarm for så vidt angår samlet overlevelse (HR = 0,975 [95 % CI: 0,760-1,249]).
English: The upper bound of one-sided 95% confidence interval (CI) for predicted effect on QTcF at Cmax was 4.8 msec. With Bazett's correction (QTcB interval), the upper bound of one-sided 95% confidence interval (CI) for predicted effect on QTcB at Cmax was 5.9 msec.
Danish: Den øvre grænse for 1-sidet 95 % konfidensinterval (CI) for forventet virkning på QTcF ved Cmax var 4,8 ms. Med Bazetts korrektion (QTcB-interval) var den øvre grænse for 1-sidet 95 % konfidensinterval for forventet virkning på QTcB ved Cmax 5,9 ms.
English: The Cmax and AUC following a 2 to 10 minute intravenous infusion of 27 mg/m2 was 4,232 ng/mL and 379 ng•hr/mL, respectively.
Danish: Cmax og AUC efter en 2-10 minutters intravenøs infusion af 27 mg/m2 var henholdsvis 4.232 ng/ml og 379 ng•t/ml.
English: 25 mg daily Cycles 13 on
Danish: 25 mg dagligt Cyklus 13 og fremefter
English: 95% CI of ORR 1-sided p-valueb
Danish: 95 % CI af ORR 1-sidet p-værdib
English: Study eligibility criteria allowed patients previously treated with carfilzomib (n = 3) or bortezomib (n = 502) to be enrolled as long as patients had at least a partial response (PR) to prior proteasome inhibitor therapy, were not removed from proteasome inhibitor therapy due to toxicity, and had at least a 6-month proteasome inhibitor treatment-free interval from last dose.
Danish: Studiets kriterier for egnethed tillod, at patienter, som tidligere var blevet behandlet med carfilzomib (n = 3) eller bortezomib (n = 502), kunne deltage, så længe de som et minimum havde partiel respons (PR) på tidligere behandling med en proteasomhæmmer; ikke var taget ud af behandling med en proteasomhæmmer på grund af toksicitet og som et minimum havde haft et 6-måneders interval uden behandling med en proteasomhæmmer siden sidste dosis.
English: Kyprolis can cause elevations of serum transaminases (see section 4.8).
Danish: Kyprolis kan medføre stigning i serum-aminotransferaser (se pkt.
English: Carfilzomib is primarily metabolised via peptidase and epoxide hydrolase activities, and as a result, the pharmacokinetic profile of carfilzomib is unlikely to be affected by concomitant administration of cytochrome P450 inhibitors and inducers.
Danish: Carfilzomib metaboliseres primært gennem peptidase- og epoxidhydrolase-aktivitet, og carfilzomibs farmakokinetiske profil vil derfor sandsynligvis ikke blive påvirket af samtidig administration af cytochrom P450-hæmmere og -induktorer.
English: Subjects had received 1 to 3 prior lines of therapy (median of 2), including prior treatment with bortezomib (66%), thalidomide (44%) and lenalidomide (20%).
Danish: Patienterne havde fået 1 til 3 tidligere behandlingsforløb (median 2), herunder tidligere behandling med bortezomib (66 %), thalidomid (44 %) og lenalidomid (20 %).
English: • Pain in limbs, hands or feet
Danish: • Smerter i arme, ben, hænder eller fødder
English: Hypertensive crises (hypertensive urgency or hypertensive emergency) have occurred following administration of Kyprolis.
Danish: Der er opstået tilfælde af hypertensiv krise (akut alvorlig hypertension [urgency] og akut hypertensiv krise [emergency]) efter administration af Kyprolis.
English: The pharmacokinetics of carfilzomib has not been studied in patients with severe hepatic impairment (bilirubin > 3 x ULN and any AST).
Danish: Carfilzomibs farmakokinetik er ikke undersøgt hos patienter med svært nedsat leverfunktion (bilirubin > 3 x ULN og vilkårlig ASAT).
English: Calculate the dose (mg/m2) and number of vials of Kyprolis required using the patient's BSA at baseline.
Danish: Beregn dosis (mg/m2) og det nødvendige antal hætteglas med Kyprolis på baggrund af patientens BSA ved baseline.
English: Patients with moderate or severe renal impairment were enrolled in Kyprolis-dexamethasone combination studies, but were excluded from Kyprolis-lenalidomide combination studies.
Danish: Patienter med moderat eller svært nedsat nyrefunktion deltog i Kyprolis-dexamethasonkombinationsstudier, men blev udelukket fra Kyprolis-lenalidomid-kombinationsstudier.
English: The dose of 2 mg/kg/dose in rats is approximately half the recommended dose in humans of 27 mg/m2 based on BSA.
Danish: Doser på 2 mg/kg/dosis til rotter er cirka det halve af den anbefalede humane dosis på 27 mg/m2 baseret på BSA.
English: In addition, due to an increased risk of venous thromboembolic events associated with carfilzomib, females should avoid the use of hormonal contraceptives that are associated with a risk of thrombosis during treatment with carfilzomib (see sections 4.4 and 4.8).
Danish: Da der er øget risiko for venøse tromboemboliske hændelser forbundet med carfilzomib, bør kvindelige patienter desuden undlade at bruge hormonelle kontraceptiva, der er forbundet med risiko for trombose, under behandling med carfilzomib (se pkt.
English: Following initial doses of carfilzomib at 20 mg/m2, the dose was increased to 27 mg/m2 in study PX-171-009 and to 56 mg/m2 in study 2011-003 (see section 5.1).
Danish: Efter initialdoser af carfilzomib på 20 mg/m2 blev dosis øget til 27 mg/m2 i studie PX-171-009 og til 56 mg/m2 i studie 2011-003 (se pkt.
English: • A side effect called tumour lysis syndrome, which can be caused by the rapid breakdown of tumour cells and may cause irregular heartbeat, kidney failure or abnormal blood test results
Danish: • En bivirkning, der kaldes for tumorlysesyndrom, som skyldes den hurtige nedbrydning af kræftceller og kan medføre uregelmæssig hjerterytme, nyresvigt eller unormale blodprøveresultater
English: An evaluation of possible effects of carfilzomib on cardiac function was performed by analysing, via central blind reading, triplicate ECG in 154 subjects with advanced malignancies, including multiple myeloma.
Danish: Carfilzomibs mulige virkninger på hjertefunktionen blev undersøgt ved en central, blindet vurdering af tre ekg-optagelser fra hver af 154 patienter med fremskredne maligniteter, herunder myelomatose.
English: Do not take Kyprolis if you are breast-feeding.
Danish: Du må ikke bruge Kyprolis, hvis du ammer.
English: Serum potassium levels should be monitored monthly, or more frequently during treatment with Kyprolis as clinically indicated and will depend on the potassium levels measured before the start of treatment, concomitant therapy used (e.g. medicinal products known to increase the risk of hypokalaemia) and associated comorbidities.
Danish: Serumkalium skal monitoreres månedligt eller oftere under behandling med Kyprolis, alt efter klinisk indikation og afhængigt af de kaliumniveauer, der er målt inden behandlingens start, samtidigt givne behandlinger (fx lægemidler, der vides at øge risikoen for hypokaliæmi) og associerede komorbiditeter.
English: Lung infection Influenza Herpes zoster* Urinary tract infection Bronchitis Gastroenteritis Viral infection Nasopharyngitis Rhinitis
Danish: Lungeinfektion Influenza Herpes zoster* Urinvejsinfektion Bronkitis Gastroenteritis Virusinfektion Nasofaryngitis Rhinitis
English: Reconstitution and preparation for intravenous administration Kyprolis vials contain no antimicrobial preservatives and are intended for single use only.
Danish: Rekonstitution og klargøring til intravenøs administration Hætteglassene med Kyprolis indeholder ingen antimikrobielle konserveringsmidler og er kun beregnet til engangsbrug.
English: Stop Kyprolis until TLS is resolved (see section 4.2).
Danish: Stop behandling med Kyprolis, indtil TLS er svundet (se pkt.
English: Acute respiratory distress syndrome (ARDS), acute respiratory failure, and acute diffuse infiltrative pulmonary disease such as pneumonitis and interstitial lung disease have occurred in patients receiving Kyprolis.
Danish: Der er opstået akut lungesvigt (ARDS), akut respirationsinsufficiens og akut diffus infiltrativ lungesygdom såsom pneumonitis og interstitiel lungesygdom hos patienter, der fik Kyprolis.
English: Carfilzomib had antiproliferative and proapoptotic activities in preclinical models in haematologic tumours.
Danish: Carfilzomib har udvist antiproliferativ og proapoptotisk aktivitet i prækliniske modeller i hæmatologiske tumorer.
English: • Leg or arm pain or swelling (which could be a symptom of blood clots in the deep veins of the leg or arm), chest pain or shortness of breath (which may be a symptom of blood clots in the lungs)
Danish: • Smerter eller hævelser på ben eller arme (som kan være et symptom på blodpropper i de dybe vener i benet eller armen), brystsmerter eller stakåndethed (som kan være et symptom på blodpropper i lungerne)
English: Based on high number of cases, plausible mechanism and seriousness of the risk, hepatitis B reactivation is proposed to be added as an adverse drug reaction in the SmPC and PL. A relevant warning should also be included.
Danish: På baggrund af det store antal tilfælde, den plausible mekanisme og risikoens alvorsgrad, foreslås det at tilføje hepatitis B som en bivirkning i produktresuméet og indlægssedlen.
English: The most common adverse reactions (occurring in > 20% of subjects) were: anaemia, fatigue, thrombocytopenia, nausea, diarrhoea, pyrexia, dyspnoea, respiratory tract infection, cough and neutropenia.
Danish: De hyppigste bivirkninger (forekom hos > 20 % af patienterne) var: anæmi, træthed, trombocytopeni, nausea, diaré, pyreksi, dyspnø, luftvejsinfektion, hoste og neutropeni.
English: Carfilzomib was not mutagenic in the in vitro bacterial reverse mutation (Ames) test and was not clastogenic in the in vivo mouse bone marrow micronucleus assay.
Danish: Carfilzomib var ikke mutagent i en in vitro bakteriel tilbagemutationstest (Ames' test) og var ikke klastogent i en in vivo mikronukleusanalyse i knoglemarv fra mus.
English: Anxiety Confusional state
Danish: Angst Konfusionstilstand
English: As Kyprolis is administered in combination with other medicinal products, refer to their summaries of product characteristics for additional contraindications.
Danish: Kyprolis administreres i kombination med andre lægemidler, og der henvises til de andre lægemidlers produktresuméer for information om yderligere kontraindikationer.
English: Each vial contains 10 mg, 30 mg or 60 mg of carfilzomib.
Danish: Hvert hætteglas indeholder 10 mg, 30 mg eller 60 mg carfilzomib.
English: Patients with New York Heart Association (NYHA) Class III and IV heart failure, recent myocardial infarction, and conduction abnormalities uncontrolled by medicinal products were not eligible for the clinical trials.
Danish: Patienter med hjerteinsufficiens NYHA- (New York Heart Association) klasse III og IV, nyligt myokardieinfarkt og ledningsforstyrrelser, der ikke kontrolleres med lægemidler, kunne ikke deltage i de kliniske studier.
English: If the hypertension cannot be controlled, the Kyprolis dose should be reduced.
Danish: Dosis af Kyprolis bør reduceres, hvis hypertensionen ikke kan kontrolleres.