FrancophonIA/ELRC3.0 huggingface dataset:
English: A pre-planned second interim OS analysis was performed after 189 deaths in the Kd arm and 209 deaths in the Vd arm. At the time of the analysis, 80% of the targeted events were registered.
Danish: Der blev udarbejdet en planlagt anden interimanalyse af OS efter 189 dødsfald i Kd-armen og 209 dødsfald i Vd-armen.
English: DO NOT SHAKE.
Danish: MÅ IKKE OMRYSTES.
English: • If absolute neutrophil count returns to baseline grade and fever resolves, resume at the same dose level
Danish: • Genoptag med samme dosisniveau, hvis absolut neutrofiltal vender tilbage til niveauet ved baseline, og feberen svinder
English: Kyprolis must not be administered as an intravenous push or bolus.
Danish: Kyprolis må ikke administreres som en intravenøs push- eller bolus-injektion.
English: Hypokalaemia Hyperglycaemia Decreased appetite
Danish: Hypokaliæmi Hyperglykæmi Appetitløshed
English: • Swollen ankles, feet or hands, loss of appetite, passing less urine, or abnormal blood test results, which may be symptoms of kidney problems or kidney failure
Danish: • Hævede ankler, fødder eller hænder, appetitløshed, mindre urinproduktion eller unormale blodprøveresultater, hvilket kan være tegn på nyreproblemer eller nyresvigt
English: Kyprolis Dose
Danish: Kyprolis-dosis
English: Cases of Hepatitis B Virus (HBV) reactivation have been reported in patients receiving carfilzomib.
Danish: Der er rapporteret om tilfælde af reaktivering af hepatitis B-virus (HBV) hos patienter i behandling med carfilzomib.
English: Baseline hepatic function status had no marked effect on the total systemic exposure (AUClast) of carfilzomib following single or repeat-dose administration (geometric mean ratio in AUClast at the 27 mg/m2 dose in cycle 1, day 16 for mild and moderate impairment versus normal hepatic function were 144.4% and 126.1%, respectively; and at the 56 mg/m2 dose in cycle 2, day 1 were 144.7% and 121.1%).
Danish: Status for leverfunktion ved baseline havde ingen udtalt indvirkning på den samlede systemiske eksponering (AUClast) af carfilzomib efter administration af enkeltdoser eller gentagne doser (geometrisk gennemsnitsratio for AUClast ved dosen på 27 mg/m2 i cyklus 1, dag 16, var for let og moderat nedsat leverfunktion vs. normal leverfunktion henholdsvis 144,4 % og 126,1 % og ved dosen på 56 mg/m2 i cyklus 2, dag 1, henholdsvis 144,7 % og 121,1 %).
English: Liver enzymes and bilirubin should be assessed at treatment initiation and monitored monthly during treatment with carfilzomib, regardless of baseline values, and appropriate dose modifications based on toxicity should be made (see table 3).
Danish: Leverenzymer og bilirubin skal vurderes ved behandlingsstart med carfilzomib og monitoreres månedligt under behandlingen uanset værdierne ved baseline, og dosis justeres på passende vis på baggrund af toksicitet (se tabel 3).
English: Do not administer as an intravenous push or bolus.
Danish: Må ikke administreres som en intravenøs push- eller bolus-injektion.
English: Discard any unused portion left in the vial.
Danish: Eventuelle ubrugte portioner i hætteglasset skal kasseres.
English: The incidence of hypertension adverse events was similar between those with or without a prior medical history of hypertension.
Danish: Forekomsten af hypertensive hændelser var den samme hos patienter med hypertension i anamnesen som uden.
English: Other non-haematologic toxicity
Danish: Anden ikke-hæmatologisk toksicitet
English: Kyprolis monotherapy in patients with relapsed and refractory multiple myeloma
Danish: Monoterapi med Kyprolis til patienter med recidiveret og refraktær myelomatose
English: • Infusion reaction
Danish: • Infusionsreaktion
English: • Stop dose
Danish: • Stop dosering
English: • Fever, chills or shaking, joint pain, muscle pain, facial flushing, or swelling of the face, lips, tongue and/or throat which may cause difficulty breathing or swallowing (angioedema), weakness, shortness of breath, low blood pressure, fainting, chest tightness, or chest pain can occur as a reaction to the infusion
Danish: • Feber, kulderystelser eller rysten, ledsmerter, muskelsmerter, rødme eller hævelse i ansigtet, læberne, tungen og/eller svælget, som kan gøre det svært at trække vejret eller synke (angioødem), svækkelse, stakåndethed, lavt blodtryk, besvimelse, trykken for brystet eller brystsmerter kan opstå som en reaktion på infusionen
English: The safety and efficacy of Kyprolis in paediatric patients have not been established.
Danish: Kyprolis' sikkerhed og virkning hos børn er ikke klarlagt.
English: Cases of haemorrhage (e.g. gastrointestinal, pulmonary and intracranial haemorrhage) have been reported in patients treated with Kyprolis, often associated with thrombocytopenia.
Danish: Der er indberettet tilfælde af blødning (fx gastrointestinal, pulmonal og intrakraniel blødning) hos patienter, der blev behandlet med Kyprolis - ofte forbundet med trombocytopeni.
English: PRES, formerly termed reversible posterior leukoencephalopathy syndrome (RPLS), is a rare, neurological disorder, which can present with seizure, headache, lethargy, confusion, blindness, altered consciousness, and other visual and neurological disturbances, along with hypertension, and the diagnosis is confirmed by neuro-radiological imaging.
Danish: er en sjælden neurologisk lidelse, der kan manifestere sig med krampeanfald, hovedpine, letargi, konfusion, blindhed, ændret bevidsthedsniveau og andre visuelle og neurologiske forstyrrelser sammen med hypertension.
English: Concomitant medicinal products
Danish: Samtidige behandlinger
English: The pharmacokinetics of carfilzomib was studied in two dedicated renal impairment studies.
Danish: Carfilzomibs farmakokinetik blev undersøgt i to specifikke studier med patienter med nedsat nyrefunktion.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det (de) aktive stof(fer) eller over for et eller flere af hjælpestofferne anført i pkt.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution, se pkt.
English: Pharmacokinetic data were collected from patients following administration of a 27 mg/m2 dose as a 30 minute infusion on cycle 1, day 16 and the 56 mg/m2 dose on cycle 2, day 1.
Danish: Der blev indsamlet farmakokinetiske data fra patienterne efter administration af en dosis på 27 mg/m2 som en 30-minutters infusion i cyklus 1, dag 16, og dosen på 56 mg/m2 i cyklus 2, dag 1.
English: A 30 minute infusion resulted in a similar half-life and AUC, but 2- to 3-fold lower Cmax compared to that observed with a 2 to 10 minute infusion of the same dose.
Danish: For samme dosis medførte 30 minutters infusionstid samme halveringstid og AUC som en infusionstid på 2-10 minutter, men en 2-3 gange lavere Cmax.
English: • Very high blood pressure, severe chest pain, severe headache, confusion, blurred vision, nausea and vomiting, or severe anxiety, which may be signs of a condition known as hypertensive crisis
Danish: • Meget højt blodtryk, kraftige brystsmerter, kraftig hovedpine, forvirring, sløret syn, kvalme og opkastning eller svær angst, hvilket kan være tegn på en tilstand, der kaldes for hypertensiv krise
English: Based on its pharmacological properties, a risk to the suckling child cannot be excluded.
Danish: En risiko for det diende barn kan ikke udelukkes ud fra stoffets farmakologiske egenskaber.
English: Patients in the Kyprolis, lenalidomide, and dexamethasone (KRd) arm demonstrated improved progression-free survival (PFS) compared with those in the lenalidomide and dexamethasone (Rd) arm, (HR = 0.69, with 1-sided p value < 0.0001) which represents a 45% improvement in PFS or a 31% reduction in the risk of event as determined using standard objective International Myeloma Working Group (IMWG)/European Blood and Marrow Transplantation (EBMT) response criteria by an Independent Review Committee (IRC).
Danish: Patienter i armen med Kyprolis, lenalidomid og dexamethason (KRd) udviste forbedret progressionsfri overlevelse (PFS) sammenlignet med patienter i armen med lenalidomid og dexamethason (Rd) (HR = 0,69 med en 1-sidet p-værdi på < 0,0001), hvilket udgør en forbedring af PFS på 45 % eller en risikoreduktion på 31 %, fastlagt af en uafhængig kontrolkomité (IRC) med anvendelse af IMWG's/EBMT's objektive standardkriterier for respons.
English: Serious adverse reactions that may occur during Kyprolis treatment include: cardiac failure, myocardial infarction, cardiac arrest, myocardial ischaemia, interstitial lung disease, pneumonitis, acute respiratory distress syndrome, acute respiratory failure, pulmonary hypertension, dyspnoea, hypertension including hypertensive crises, acute kidney injury, tumour lysis syndrome, infusion related reaction, gastrointestinal haemorrhage, intracranial haemorrhage, pulmonary haemorrhage, thrombocytopenia, hepatic failure, hepatitis B virus reactivation, PRES, thrombotic microangiopathy and TTP/HUS.
Danish: Alvorlige bivirkninger, der kan opstå i forbindelse med Kyprolis-behandling, inkluderer: hjerteinsufficiens, myokardieinfarkt, hjertestop, myokardieiskæmi, interstitiel lungesygdom, pneumonitis, akut respiratory distress syndrome, akut respirationsinsufficiens, pulmonal hypertension, dyspnø, hypertension (herunder hypertensiv krise), akut nyreskade, tumorlysesyndrom, infusionsrelateret reaktion, gastrointestinal blødning, intrakraniel blødning, pulmonal blødning, trombocytopeni, leverinsufficiens, reaktivering af hepatitis B-virus, PRES, trombotisk mikroangiopati og TTP/HUS.
English: • Consider restarting the next scheduled treatment at 1 dose level reductiona a. See table 4 for dose level reductions
Danish: 1 dosisniveaureduktiona a. Se tabel 4 vedrørende dosisreduktion Tabel 4.
English: The disease status and other baseline characteristics were well-balanced between the two arms, including age (64 years, range 31-91 years), gender (56% male), ECOG performance status (48% with performance status 1), high-risk genetic mutations, consisting of the genetic subtypes t(4;14), t(14;16), or deletion 17p in ≥ 60% of plasma cells (13%), unknown-risk genetic mutations, which included subjects with results not collected or not analysed (47%), and baseline ISS stage III disease (20%).
Danish: Sygdomsstatus og andre baseline-karakteristika var afbalancerede mellem de to behandlingsarme, herunder alder (64 år, interval 31-91 år), køn (56 % mænd), ECOG-status (48 % med ECOG-status 1), genetiske højrisiko-mutationer, bestående af de genetiske undertyper t(4;14), t(14;16) eller deletion 17p i ≥ 60 % af plasmaceller (13 %), genetiske mutationer med ukendt risiko, hvilket inkluderede patienter, hvis resultater ikke var indsamlet eller analyseret (47 %), samt sygdom i ISS-stadie III ved baseline (20 %).
English: Patients with moderate or severe hepatic impairment were excluded from Kyprolis studies in combination with either lenalidomide and dexamethasone or dexamethasone alone.
Danish: Patienter med moderat eller svært nedsat leverfunktion blev udelukket fra studier af Kyprolis i kombination med lenalidomid plus dexamethason og dexamethason alene.
English: • Difficulty breathing, including shortness of breath at rest or with activity or a cough (dyspnoea), rapid breathing, feeling like you can't breathe in enough air, wheezing, or cough, which can be signs of lung toxicity
Danish: • Vejrtrækningsbesvær, for eksempel stakåndethed i hvile eller i forbindelse med aktiviteter eller hoste (dyspnø), hurtig vejrtrækning, en følelse af, at du ikke kan få luft nok, hvæsende vejrtrækning eller hoste, hvilket kan være tegn på skadelige virkninger på lungerne
English: Discard unused portions in accordance with local requirements.
Danish: Ubrugte portioner skal kasseres i overensstemmelse med lokale retningslinjer.
English: • Perforation of the digestive system
Danish: • Huller (perforation) i fordøjelsessystemet
English: The reconstituted solution is a clear, colourless or slightly yellow solution.
Danish: Infusionsvæsken er en klar, farveløs eller lys gullig opløsning.
English: When Kyprolis is combined with dexamethasone alone, dexamethasone is administered as 20 mg orally or intravenously on days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28 day cycles.
Danish: Når Kyprolis kombineres med dexamethason alene, administreres dexamethason som 20 mg oralt eller intravenøst på dag 1, 2, 8, 9, 15, 16, 22 og 23 i cyklusserne på 28 dage.
English: However, in phase 3 clinical studies, the incidence of adverse events of acute renal failure was higher in patients with lower baseline creatinine clearance than that among patients with higher baseline creatinine clearance.
Danish: I kliniske fase 3-studier var forekomsten af akut nyreinsufficiens dog højere hos patienter med lavere kreatininclearance ved baseline end hos patienter med højere kreatininclearance ved baseline.
English: In combination with Kyprolis, lenalidomide is administered as 25 mg orally on days 1-21 and dexamethasone is administered as 40 mg orally or intravenously on days 1, 8, 15, and 22 of the 28 day cycles.
Danish: Kyprolis administreres i kombination med lenalidomid 25 mg oralt på dag 1-21, og dexamethason administreres som 40 mg oralt eller intravenøst på dag 1, 8, 15 og 22 i 28-dages-cyklusserne.
English: ORR n (%) sCR CR VGPR PR 95% CI of ORR 1-sided p-value KRd = Kyprolis, lenalidomide and dexamethasone; Rd = lenalidomide and dexamethasone; PFS = progression-free survival; HR = hazard ratio; CI = confidence interval; OS = overall survival; ORR = overall response rate; sCR = stringent complete response; CR = complete response; VGPR = very good partial response; PR = partial response; IMWG = international myeloma working group; EBMT = European society for blood and marrow transplantation a. As determined by an Independent Review Committee using standard objective IMWG/EBMT response criteria b. Statistically significant
Danish: ORR n (%) sCR CR VGPR PR 95 % CI af ORR 1-sidet p-værdi KRd = Kyprolis, lenalidomid og dexamethason; Rd = lenalidomid og dexamethason; PFS = progressionsfri overlevelse; HR = hazard ratio; CI = konfidensinterval; OS = samlet overlevelse; ORR = samlet responsrate; sCR = stringent komplet respons; CR = komplet respons; VGPR = meget god partiel respons; PR = partiel respons; IMWG = International Myeloma Working Group; EBMT = European Society for Blood and Marrow Transplantation a. Som fastlagt af en uafhængig kontrolkomité (IRC) ved hjælp af IMWG's/EBMT's objektive standardkriterier for respons b. Statistisk signifikant
English: Kaplan-Meier curve of overall survival in relapsed multiple myeloma study 2011-003
Danish: Kaplan-Meier-kurve over data for den samlede overlevelse ved recidiveret myelomatose, studie 2011-003
English: Female patients of child bearing potential (and/or their partners) must use effective contraception measures during and for one month following treatment.
Danish: Kvindelige patienter i den fertile alder (og/eller deres partnere) skal bruge sikker kontraception under behandlingen og i 1 måned efter behandlingen.
English: • Cough which could include chest tightness or pain, nasal congestion (bronchitis)
Danish: • Hoste, som kan omfatte trykken for brystet eller brystsmerter, tilstoppet næse (bronkitis)
English: In the event of an overdose, the patient should be monitored, specifically for the adverse reactions to Kyprolis listed in section 4.8.
Danish: I tilfælde af overdosering skal patienten monitoreres, især for bivirkninger forbundet med Kyprolis (se pkt.
English: The geometric mean ratios in AUClast at the 27 mg/m2 dose cycle 1, day 16 and at the 56 mg/m2 dose cycle 2, day 1 for ESRD versus normal renal function were 139.72% and 132.75%, respectively.
Danish: De geometriske gennemsnitsratioer for AUClast ved dosen på 27 mg/m2 (cyklus 1, dag 16) og dosen på 56 mg/m2 (cyklus 2, dag 1) ved ESRD vs. normal nyrefunktion var henholdsvis 139,72 % og 132,75 %.
English: Kyprolis, as a single agent, was administered intravenously over 30 minutes at 20 mg/m2 on days 1 and 2 and at 27 mg/m2 on days 8, 9, 15 and 16 of cycle 1.
Danish: Kyprolis som enkeltstof blev administreret intravenøst i 30 minutter, 20 mg/m2 på dag 1 og 2 og 27 mg/m2 på dag 8, 9, 15 og 16 i cyklus 1.
English: Additional clinical experience has been generated with Kyprolis monotherapy in patients with relapsed and refractory multiple myeloma.
Danish: Der er indsamlet yderligere klinisk erfaring med monoterapi med Kyprolis til patienter med recidiveret og refraktær myelomatose.
English: • Cytomegalovirus infection
Danish: • Cytomegalovirusinfektion
English: Intracranial haemorrhage Cerebrovascular accident
Danish: Intrakraniel blødning Cerebrovaskulær hændelse
English: Kaplan-Meier curve of progression-free survival in relapsed multiple myelomaa
Danish: Kaplan-Meier-kurve over progressionsfri overlevelse ved recidiveret myelomatosea
English: Uncommon side effects (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (kan optræde hos op til 1 ud af 100 personer)
English: • Headaches, confusion, seizures (fits), visual loss, and high blood pressure (hypertension), which may be symptoms of a neurologic condition known as posterior reversible encephalopathy syndrome (PRES).
Danish: • Hovedpine, forvirring, krampeanfald, synstab og højt blodtryk, hvilket kan være tegn på en tilstand i hjernen (neurologisk tilstand), der kaldes for posteriort reversibelt encefalopatisyndrom (PRES).
English: Thrombocytopenia Neutropenia Anaemia
Danish: Trombocytopeni Neutropeni Anæmi
English: Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and haemolytic uraemic syndrome (TTP/HUS) have been reported in patients who received Kyprolis.
Danish: Der er indberettet tilfælde af trombotisk mikroangiopati, herunder trombotisk trombocytopenisk purpura og hæmolytisk uræmisk syndrom (TTP/HUS), hos patienter, der fik Kyprolis.
English: • Bleeding, bruising, weakness, confusion, fever, nausea, vomiting and diarrhoea, and acute kidney failure, which may be signs of a blood condition known as thrombotic microangiopathy
Danish: • Blødning, blå mærker, svækkelse, forvirring, feber, kvalme, opkastning og diaré samt akut nyresvigt, hvilket kan være tegn på en blodsygdom, der kaldes for trombotisk mikroangiopati
English: • Hepatitis B infection activated again (viral inflammation of the liver)
Danish: • Reaktivering af hepatitis B-infektion (leverbetændelse, der skyldes virus)
English: A clinical trial using oral midazolam as a CYP3A probe conducted with carfilzomib at a dose of 27 mg/m2 (2-10 minute infusion) demonstrated that the pharmacokinetics of midazolam were unaffected by concomitant carfilzomib administration, indicating that carfilzomib is not expected to inhibit the metabolism of CYP3A4/5 substrates and is not a CYP3A4 inducer in human subjects.
Danish: Et kliniske studie, som blev udført med oral midazolam som CYP3A-teststof og med carfilzomib i en dosis på 27 mg/m2 (2-10-minutters infusion), viste, at midazolams farmakokinetik ikke blev påvirket af samtidig administration af carfilzomib.
English: HR (95% CI); 1-sided p-valueb Overall survival months median (95% CI)
Danish: HR (95 % CI); 1-sidet p-værdib Samlet overlevelse, måneder, median (95 % CI)
English: The PFS benefit of KRd was consistently observed in all subgroups, including patients ≥ 75 years of age (n = 96), patients with high risk (n = 100) or unknown (n = 375) risk genetic mutations, and patients with baseline creatinine clearance of 30 - < 50 mL/min (n = 56).
Danish: Fordelen ved KRd for så vidt angår PFS blev observeret konsekvent i alle delgrupper, herunder patienter ≥ 75 år (n = 96), patienter med høj risiko (n = 100) eller ukendt risiko (n = 375) for genetiske mutationer samt patienter med en kreatininclearance ved baseline på 30 - < 50 ml/min (n = 56).
English: • Stop dose If recovered to ≥ 10 x 109/L and/or bleeding is controlled continue at same dose level
Danish: • Stop dosering Fortsæt med samme dosisniveau, hvis tallet stiger til ≥ 10 x109/l, og/eller blødningen kontrolleres
English: • For subsequent drops to < 0.5 x 109/L, follow the same recommendations as above and consider 1 dose level reduction when restarting Kyprolisa
Danish: • Følg samme anbefalinger som ovenfor ved efterfølgende fald til < 0,5 x 109/l og overvej 1 dosisniveaureduktion ved genstart af Kyprolisa
English: Male patients must use effective contraception measures during and for 3 months following treatment if their partner is pregnant or of child bearing potential not using effective contraception.
Danish: Mandlige patienter skal bruge sikker kontraception under behandlingen og i 3 måneder efter behandlingen, hvis deres partner er gravid eller i den fertile alder og ikke bruger sikker kontraception.
English: This medicine contains 0.3 mmol sodium (which is 7 mg sodium) per mL of reconstituted solution.
Danish: Dette lægemiddel indeholder 0,3 mmol natrium (svarende til 7 mg natrium) pr. ml infusionsvæske.
English: This study evaluated Kyprolis at an initial dose of 20 mg/m2, which was increased to 56 mg/m2 on cycle 1, day 8, administered twice weekly for 3 out of 4 weeks as a 30 minute infusion until progression or unacceptable toxicity.
Danish: I dette studie blev Kyprolis undersøgt som en 30-minutters infusion med initialdosis på 20 mg/m2, der blev øget til 56 mg/m2 på dag 8 i cyklus 1, og administreret to gange om ugen i 3 ud af 4 uger indtil sygdomsprogression eller uacceptabel toksicitet.
English: While taking Kyprolis and for 90 days after stopping treatment, you should use a condom even if your partner is pregnant.
Danish: Du skal bruge kondom, mens du får Kyprolis og i 90 dage efter, behandlingen er stoppet, også selvom din partner er gravid.
English: If the diagnosis of TTP/HUS is excluded, Kyprolis can be restarted.
Danish: Behandling med Kyprolis kan reinitieres, hvis diagnosen TTP/HUS udelukkes.
English: • For subsequent drops to < 10 x 109/L, follow the same recommendations as above and consider 1 dose level reduction when restarting Kyprolisa
Danish: • Følg samme anbefalinger som ovenfor ved efterfølgende fald til < 10 x109/l og overvej 1 dosisniveaureduktion ved genstart af Kyprolisa
English: Patients in the KRd arm had a 21% reduction in the risk of death compared with those in the Rd arm (HR = 0.79; 95% CI: 0.67, 0.95; p value = 0.0045).
Danish: Patienterne i KRd-armen havde 21 % mindre risiko for dødsfald sammenlignet med patienterne i Rd-armen (HR = 0,79; 95 % CI: 0,67; 0,95; p-værdi = 0,0045).
English: Dyspnoea was commonly reported in patients treated with Kyprolis.
Danish: Dyspnø er indberettet som en almindelig bivirkning hos patienter, der er blevet behandlet med Kyprolis.
English: Female patients of child bearing potential treated with Kyprolis (and/or their partners) must use effective contraception measures during and for one month following treatment.
Danish: Kvindelige patienter i den fertile alder (og/eller deres partnere), der behandles med Kyprolis, skal bruge sikker kontraception under behandlingen og i 1 måned efter behandlingen.
English: • Heart attack
Danish: • Hjerteanfald
English: Kyprolis can make some conditions worse or cause serious side effects, which may be fatal, such as heart problems, lung problems, kidney problems, tumour lysis syndrome (a life-threatening condition that occurs when cancer cells break and release their content to the bloodstream), reactions to the Kyprolis infusion, unusual bruising or bleeding, (including internal bleeding), blood clots in your veins, liver problems, certain blood conditions, or a neurological condition known as PRES. See ‘Conditions you need to look out for' in section 4.
Danish: Det kan for eksempel være problemer med hjerte, lunger eller nyrer, tumorlysesyndrom (en livstruende tilstand, der opstår, når kræftcellerne går i stykker og frigiver deres indhold ud i blodet), reaktioner på infusionen af Kyprolis, usædvanlige blå mærker eller blødning (herunder indre blødning), blodpropper i venerne, leverproblemer, visse blodtilstande eller en neurologisk tilstand, der kaldes for PRES. Se ‘Tilstande, du skal holde øje med' i afsnit 4.
English: Cardiac failure, myocardial infarction and myocardial ischaemia
Danish: Hjerteinsufficiens, myokardieinfarkt og myokardieiskæmi