FrancophonIA/ELRC3.0 huggingface dataset:
English: The 30-day results based on quadruple and triple endpoints from a randomized, double-blind trial of over 6,000 patients undergoing PCI (REPLACE-2) are shown in Table 5.
Danish: Resultaterne dag 30 baseret på firdobbelte og tredobbelte endepunkter fra en randomiseret, dobbeltblind undersøgelse med over 6000 patienter, som fik foretaget PCI (REPLACE-2), er vist i Tabel 5.
English: INR increased d
Danish: Forhøjet INR
English: ACUITY scale major bleeding
Danish: ACUITY-skala major blødning
English: Unplanned revasc.
Danish: Uplanlagt revask.
English: What Angiox contains
Danish: Angiox indeholder
English: See section 6.2 for the summary of compatible and incompatible concentrations of these compounds.
Danish: 6.2, der indeholder en oversigt over forligelige og uforligelige koncentrationer af disse stoffer.
English: Protocol defined major bleeding
Danish: Protokoldefineret major blødning
English: o while you are in hospital: tell the doctor or nurse immediatelyo after you've left hospital: contact your doctor directly or go immediately to the Emergency
Danish: o mens du er indlagt på hospital: fortæl det til en læge eller sygeplejerske med det samme o efter du har forladt hospitalet: kontakt din læge med det samme, eller søg omgående skadestue eller hospital
English: TIMI major bleeding was defined as intracranial bleeding or a decrease in haemoglobin concentration ≥5 g/dl.
Danish: TIMI major blødning blev defineret som intrakraniel blødning eller et fald i hæmoglobinkoncentrationen på ≥5 g/dl.
English: If, after this, you then need percutaneous coronary intervention (PCI) treatment, the dosage will be increased to:
Danish: Hvis du efter dette skal gennemgå en særlig behandling, som kaldes perkutan koronar intervention (PCI), vil dosis blive øget til:
English: From the knowledge of their mechanism of action, combined use of anti-coagulant medicinal products (heparin, warfarin, thrombolytics or antiplatelet agents) can be expected to increase the risk of bleeding.
Danish: På baggrund af kendskab til virkningsmekanismen kan kombineret brug af antikoagulantia (heparin, warfarin, trombolytika eller trombocythæmmende stoffer) forventes at øge risikoen for blødning.
English: Reconstituted and diluted product should be thoroughly mixed prior to administration.
Danish: Rekonstitueret og fortyndet produkt skal blandes grundigt inden indgivelse.
English: Angiox is a white to off-white powder in a glass vial.
Danish: Angiox er et hvidt til råhvidt pulver i et hætteglas.
English: Antithrombotics are medicines which prevent the formation of blood clots (thrombosis).
Danish: Antitrombotiske lægemidler forhindrer dannelsen af blodpropper (tromber).
English: Detailed information on this medicinal product is available on the web site of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu,.
English: Gum bleeding (uncommon, may affect up to 1 in 100 people) is usually not serious.
Danish: Blødende gummer (ikke almindelig, kan forekomme hos op til 1 ud af 100 personer) er normalt ikke alvorligt.
English: Mannitol, sodium hydroxide 2%
Danish: Mannitol, natriumhydroxid 2 %
English: If you are breast-feeding, the doctor will decide whether Angiox should be used.
Danish: Hvis du ammer, vil din læge vurdere, om Angiox må anvendes.
English: Heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia-thrombosis syndrome (HIT/HITTS)
Danish: HeparinInduceret Trombocytopeni (HIT) og HeparinInduceret TrombocytopeniTromboseSyndrom (HIT/HITTS)
English: OUTER CARTON (pack of 10 vials)
Danish: YDRE PAKNING/KARTON (indeholder 10 hætteglas)
English: Patients in Arms A and B were also randomised to receive a GP IIb/IIIa inhibitor either upfront at the time of randomization (prior to angiography) or at the time of PCI.
Danish: Patienter i arm A og B blev også randomiseret til behandling med GP IIb/IIIa-inhibitor enten på randomiseringstidspunktet (før angiografi) eller ved PCI.
English: Five patients had a post-baseline nadir platelet count of <150,000 cells/mm
Danish: 5 patienter havde et trombocyttal efter baseline med en nadirværdi på <150.000 celler/mm
English: The most common, (may affect up to 1 in 10 people) serious side effect of treatment with Angiox, is major bleeding which could occur anywhere inside the body (e.g. stomach, digestive system (including vomiting blood or passing blood with the stools), abdomen, lungs, groin, bladder, heart, eye, ear, nose or brain).
Danish: De hyppigste (kan forekomme hos op til 1 ud af 10 personer) alvorlige bivirkninger ved behandling med Angiox er større blødning, der kan forekomme overalt inde i kroppen (f.eks. mave, fordøjelse (herunder opkastning af blod eller blod i afføringen), abdomen, lunger, lyske, blære, hjerte, øjne, ører, næse eller hjerne).
English: The pharmacokinetics of bivalirudin have not been studied in patients with hepatic impairment but are not expected to be altered because bivalirudin is not metabolized by liver enzymes such as cytochrome P-450 isozymes.
Danish: Bivalirudins farmakokinetik er ikke undersøgt hos patienter med nedsat leverfunktion, men forventes at være uændret, idet bivalirudin ikke metaboliseres af leverenzymer som cytokrom P-450 isoenzymer.
English: Angiox is used to treat patients:
Danish: Angiox anvendes til patienter:
English: In healthy volunteers and patients, bivalirudin exhibits dose- and concentration-dependent anticoagulant activity as evidenced as prolongation of the ACT, aPTT, PT, INR and TT. Intravenous administration of bivalirudin produces measurable anticoagulation within minutes.
Danish: Hos raske frivillige og patienter udviser bivalirudin en dosis- og koncentrationsafhængig antikoagulationsaktivitet påvist ved forlængelse af ACT, aPTT, PT, INR og TT. Intravenøs administration af bivalirudin viser målbar antikoagulation inden for minutter.
English: In clinical studies bivalirudin has been shown to provide adequate anticoagulation during PCI procedures.
Danish: I kliniske undersøgelser har bivalirudin vist sig at give tilstrækkelig antikoagulation under PCIprocedurer.
English: This medicine contains less than 23 mg of sodium per vial, which means that it is essentially “sodiumfree”.
Danish: Lægemidlet indeholder mindre end 23 mg natrium pr. hætteglas, dvs. det er i det væsentlige ”natriumfri”.
English: Angiox should be administered with acetylsalicylic acid and clopidogrel.
Danish: Angiox bør administreres sammen med acetylsalicylsyre og clopidogrel.
English: The following data is based on a clinical study of bivalirudin in 6,000 patients undergoing PCI, half of whom were treated with bivalirudin (REPLACE-2).
Danish: Følgende data er baseret på en klinisk undersøgelse med bivalirudin med 6.000 patienter, som fik foretaget PCI, hvoraf halvdelen blev behandlet med bivalirudin (REPLACE-2).
English: Talk to your doctor before using Angiox.
Danish: Kontakt lægen, før du bruger Angiox,
English: • In patients receiving warfarin, INR is increased by administration of bivalirudin.
Danish: • Hos patienter, som får warfarin, øges INR ved administration af bivalirudin.
English: Bivalirudin inhibits each of these thrombin effects.
Danish: Bivalirudin hæmmer alle disse trombinvirkninger.
English: A total of 17 deaths occurred after subacute stent thrombosis, 3 in the bivalirudin arm and 14 in the UFH plus GP IIb/IIIa arm.
Danish: I alt forekom der 17 dødsfald efter subakut stenttrombose, 3 i bivalirudinarmen og 14 i UFH plus GP IIb/IIIa-armen.
English: Patients must be observed carefully for symptoms and signs of bleeding during treatment particularly if bivalirudin is combined with another anticoagulant (see section 4.5).
Danish: Patienten skal observeres omhyggeligt for symptomer og tegn på blødning under behandlingen, navnlig hvis bivalirudin kombineres med et andet antikoagulantium (se pkt.
English: To ensure appropriate administration of bivalirudin, the completely dissolved, reconstituted and diluted product should be thoroughly mixed prior to administration (see section 6.6).
Danish: For at sikre en hensigtsmæssig administration af bivalirudin skal det helt opløste, rekonstituerede og fortyndede præparat blandes grundigt før anvendelse (se pkt.
English: The primary metabolite resulting from the cleavage of Arg3-Pro4 bond of the Nterminal sequence by thrombin is not active because of the loss of affinity to the catalytic active site of thrombin.
Danish: Den primære metabolit, som fremkommer når Arg3-Pro4-bindingen af den N-terminale sekvens fraspaltes af trombin, er ikke aktiv på grund af tabet af affinitet til det katalytiske site på trombin.
English: This is administered and supervised by a doctor experienced in caring for patients with heart disease.
Danish: Dette udføres af en læge med erfaring inden for behandling af hjertesygdomme.
English: Pharmacokinetic studies indicate that hepatic metabolism of bivalirudin is limited, therefore the safety and efficacy of bivalirudin have not been specifically studied in patients with hepatic impairment.
Danish: Farmakokinetiske undersøgelser viser, at levermetabolisme af bivalirudin er begrænset, og man har derfor ikke specifikt undersøgt virkning og sikkerhed af bivalirudin hos patienter med nedsat leverfunktion.
English: ACT values 5 minutes after bivalirudin bolus average 365 +/- 100 seconds.
Danish: 5 minutter efter bivalirudin bolus ligger ACT-værdien i gennemsnit på 365  100 sekunder.
English: Major bleeding in the HORIZONS study was also defined using the ACUITY scale.
Danish: Major blødning i HORIZONS-studiet blev defineret ved hjælp af ACUITY-skalaen.
English: Table 9 summarises compatible and incompatible concentrations of these compounds.
Danish: I Tabel 9 opsummeres kendte forligelige og uforligelige koncentrationer af disse stoffer.
English: Angiox is not intended for intramuscular use.
Danish: Angiox er ikke beregnet til intramuskulær brug.
English: Increased awareness due to high bleeding risk should be exercised in the elderly because of age-related decrease in renal function.
Danish: Der bør udvises særlig opmærksomhed på grund af høj risiko for blødning ved behandling af ældresom følge af aldersbetinget nedsat nyrefunktion.
English: The binding of bivalirudin to thrombin, and therefore its activity, is reversible as thrombin slowly cleaves the bivalirudin, Arg3-Pro4, bond, resulting in recovery of thrombin active site function.
Danish: Bindingen af bivalirudin til trombin - og dermed dets aktivitet - er reversibel, idet trombin langsomt spalter bivalirudin, Arg3-Pro4-bindingen, hvilket medfører en genetablering af trombins funktion som aktiv site.
English: Similar reductions in bleeding were observed in patients who were switched to bivalirudin from heparin-based therapies (N = 2,078).
Danish: Lignende fald i antal blødninger blev observeret hos patienter, der blev skiftet fra heparinbaseret behandling til behandling med bivalirudin (N=2.078).
English: For patients with acute coronary syndromes (ACS) who are treated medically the recommended starting dose is:
Danish: For patienter med akut koronar syndrom (AKS), som behandles medicinsk, er den anbefalede startdosis:
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlingskompl ikationer
English: Thrombin plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently crosslinked framework that stabilises the thrombus.
Danish: Trombin spiller en central rolle i den trombotiske proces ved at spalte fibrinogen til fibrinmonomerer og ved at aktivere faktor XIII til faktor XIIIa, således at fibrin danner et kovalent krydsbundet netværk, som stabiliserer tromben.
English: Use with other anticoagulant therapy
Danish: Brug sammen med andre antikoagulantia
English: Bivalirudin is metabolized by proteases, including thrombin.
Danish: Bivalirudin metaboliseres af proteaser, inklusive trombin.
English: Dose adjustments for this age group should be on the basis of renal function.
Danish: Dosisjustering i denne aldersgruppe bør foretages på basis af den enkeltes nyrefunktion.
English: All patients received acetylsalicylic acid and clopidogrel with twice as many patients (approximately 64%) receiving a 600mg loading dose of clopidogrel than a 300mg loading dose of clopidogrel.
Danish: Alle patienter fik acetylsalicylsyre og clopidogrel, og dobbelt så mange patienter (omtrent 64 %) fik en begyndelsesdosis clopidogrel på 600 mg i stedet for en begyndelsesdosis clopidogrel på 300 mg.
English: • if bleeding occurs (if this happens, treatment with Angiox will be stopped).
Danish: • hvis der opstår blødning (Angiox-behandling afbrydes, hvis dette sker).
English: Patients with renal impairment should be carefully monitored for clinical signs of bleeding during PCI, as clearance of bivalirudin is reduced in these patients (see section 5.2)
Danish: Patienter med nedsat nyrefunktion skal monitoreres omhyggeligt for kliniske tegn på blødning under PCI, eftersom clearance af bivalirudin er nedsat hos disse patienter (se pkt.
English: Check with the doctor if you are unsure.
Danish: Tal med din læge, hvis du er i tvivl.
English: In patients taking warfarin who are treated with bivalirudin, International Normalised Ratio (INR) monitoring should be considered to ensure that it returns to pre-treatment levels following discontinuation of bivalirudin treatment.
Danish: Hos patienter, som tager warfarin og behandles med bivalirudin, skal det overvejes at monitorere INR (International Normaliseret Ratio) for at sikre, at det vender tilbage til niveauerne fra før behandling efter seponering af bivalirudinbehandlingen.
English: o while you are in hospital: tell the doctor or nurseo after you've left hospital: first seek advice from your doctor.
Danish: o mens du er indlagt på hospital: fortæl det til en læge eller sygeplejerske o efter du har forladt hospitalet: søg først råd hos lægen.
English: Bivalirudin does not bind to plasma proteins (other than thrombin) or to red blood cells.
Danish: Bivalirudin binder sig ikke til plasmaproteiner (andre end trombin) eller til erytrocytter.
English: Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på glas og karton efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Hälsa Pharma GmbH, Nikolaus Dürkopp-Str. 4A, 33602 Bielefeld, GERMANY
Danish: Hälsa Pharma GmbH, Nikolaus Dürkopp-Str. 4A, 33602 Bielefeld, Tyskland
English: Very common side effects (may affect more than 1 in 10 people): • Minor bleeding
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) • mindre blødning
English: Cases of overdose of up to 10 times the recommended dose have been reported in clinical trials.
Danish: I kliniske studier er der rapporteret om overdosering ved op til 10 gange den anbefalede dosering.
English: Angiox should not be used during pregnancy, unless clearly necessary.
Danish: Angiox må kun anvendes under graviditet, hvis det er tvingende nødvendigt.
English: • Angiox is contraindicated in patients with severe renal insufficiency (glomerular filtration rate
Danish: • Angiox er kontraindiceret til patienter med svær nyreinsufficiens (glomerulær filtrationsrate
English: Such a reaction is uncommon (may affect up to 1 in 100 people).
Danish: Sådanne reaktioner er ikke almindelige (kan forekomme hos op til 1 ud af 100 personer).
English: Allergic type hypersensitivity reactions were reported uncommonly (≥1/1,000 to ≤1/100) in clinical trials.
Danish: Allergiske hypersensitivitetsreaktioner er rapporteret med hyppigheden ”ikke almindelig” (≥ 1/1.000 til ≤ 1/100) i de kliniske forsøg.
English: Thrombocytopenia was reported in 10 bivalirudin-treated patients participating in the ACUITY study (0.1%).
Danish: Trombocytopeni blev rapporteret hos 10 bivalirudin-behandlede patienter, som deltog i ACUITYundersøgelsen (0,1 %).
English: The clearance of bivalirudin is similar in patients with normal renal function and those with mild renal impairment.
Danish: Clearance af bivalirudin er ens hos patienter med normal nyrefunktion og hos patienter med let nedsat nyrefunktion.
English: Angiox contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.
Danish: Angiox indeholder mindre end 1 mmol natrium (23 mg) pr. hætteglas, dvs. det er i det væsentlige ”natriumfri”.
English: In vitro studies have also shown that bivalirudin prolongs the activated partial thromboplastin time (aPTT) thrombin time (TT) and pro-thrombin time (PT) of normal human plasma in a concentrationdependent manner and that bivalirudin does not induce a platelet aggregation response against sera from patients with a history of Heparin-Induced Thrombocytopenia/Thrombosis Syndrome (HIT/HITTS).
Danish: In vitro undersøgelser har også vist, at bivalirudin forlænger den aktiverede partielle tromboplastintid (aPTT), trombintiden (TT) og pro-trombintiden (PT) i normal human plasma på en koncentrationsafhængig måde og at bivalirudin ikke inducerer blodpladeaggregationsrespons mod sera fra patienter med kendt tidligere Heparin-Induceret-Trombocytopeni/Trombose Syndrom (HIT/HITTS).
English: 2Major bleeding was defined using the ACUITY bleeding scale.
Danish: 2Major blødning blev defineret ved hjælp af blødningsskalaen i ACUITY.
English: Patients should remain for at least 24 hours in a facility capable of managing ischaemic complications and should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischaemia.
Danish: Patienter skal blive mindst 24 timer på en klinik, som kan behandle iskæmiske komplikationer, og skal monitoreres omhyggeligt efter primær PCI for tegn og symptomer på myokardieiskæmi.
English: You can also report side effects directly via the national reporting system listed in Appendix V.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V.
English: A population pharmacokinetic/pharmacodynamic analysis, and an Exposure and Adverse Event Assessment Model based on the data from this study determined that in paediatric patients, use of the adult dosing with plasma levels similar to that achieved in adults was associated with lower levels of thrombotic events with no impact on bleeding events (see section 4.2).
Danish: En farmakokinetisk/farmakodynamisk populationsanalyse og en model for evaluering af eksponering og bivirkninger, som var baseret på data fra denne undersøgelse, har fastslået, at brug af voksendoser med plasmaniveauer, der ligner dem, som blev opnået hos voksne, hos børn er forbundet med færre trombotiske hændelser og ingen indvirkning på blødningshændelser (se pkt.
English: Combined use of anti-coagulant medicinal products can be expected to increase the risk of bleeding (see section 4.5).
Danish: Kombineret anvendelse af antikoagulantia kan forventes at øge blødningsrisikoen (se pkt.
English: The doctor will decide for how long you should be treated.
Danish: Lægen vil fastlægge, hvor lang tid behandlingen skal vare.
English: The following six medicinal products show dose-concentration incompatibilities with bivalirudin.
Danish: Følgende 6 lægemidler udviser koncentrationsafhængig uforligelighed med bivalirudin.
English: Angiox contains a substance called bivalirudin which is an antithrombotic medicine.
Danish: Angiox indeholder stoffet bivalirudin, som er et antitrombotisk lægemiddel.
English: Angiox is intended for intravenous use.
Danish: Angiox er beregnet til intravenøs anvendelse.
English: Thrombin also activates Factors V and VIII, promoting further thrombin generation, and activates platelets, stimulating aggregation and granule release.
Danish: Trombin aktiverer også faktor V og VIII, som fremmer yderligere trombindannelse og aktiverer trombocytterne, hvilket stimulerer aggregation og frigivelse fra granula.
English: Death
Danish: Død
English: Angiox should be administered by a physician experienced in either acute coronary care or in coronary intervention procedures.
Danish: Angiox skal administreres af læger med erfaring inden for akut koronarbehandling eller koronare interventionsprocedurer.
English: In REPLACE-2 thrombocytopenia occurred in 20 bivalirudin-treated patients (0.7%).
Danish: I REPLACE-2 forekom trombocytopeni hos 20 bivalirudinbehandlede patienter (0,7 %).
English: There are no gender effects in the pharmacokinetics of bivalirudin.
Danish: Køn Der er ingen kønsforskelle i bivalirudins farmakokinetik.
English: The bolus dose should not be changed from the posology described under ACS or PCI above.
Danish: Bolusdosis skal bibeholdes som beskrevet ovenfor ved AKS eller PCI.
English: A total of 356 (7.7%) of patients randomised to Arm C also received a GP IIb/IIIa inhibitor.
Danish: I alt 356 patienter (7,7 %) som var randomiseret til arm C blev også behandlet med en GP IIb/IIIa-inhibitor.
English: Angiox can be used in conjunction with a GP IIb/IIIa inhibitor.
Danish: Angiox kan benyttes sammen med en GPIIb/IIIa-inhibitor.
English: Major bleeding rates in clinical trials of bivalirudin 30 day endpoints for intent-to
Danish: Hyppigheden af major blødning i kliniske forsøg med bivalirudin 30-dages endepunkt for intent-to-treat-populationer.
English: Patients can be started on Angiox 30 minutes after discontinuation of unfractionated heparin given intravenously, or 8 hours after discontinuation of low molecular weight heparin given subcutaneously.
Danish: Angioxbehandlingen kan påbegyndes 30 minutter efter seponering af intravenøst administreret ufraktioneret heparin eller 8 timer efter seponering af subkutant administreret lavmolekylært heparin.
English: The pharmacokinetic properties of bivalirudin have been evaluated and found to be linear in patients undergoing Percutaneous Coronary Intervention and in patients with ACS.
Danish: De farmakokinetiske egenskaber af bivalirudin er blevet undersøgt og har vist sig at være lineære hos patienter, som skal have foretaget perkutan koronar intervention og hos patienter med AKS.
English: As a peptide, bivalirudin is expected to undergo catabolism to its constituent amino acids, with subsequent recycling of the amino acid in the body pool.
Danish: Da bivalirudin er et peptid, forventes det at blive kataboliseret til dets bestanddele af aminosyrer med efterfølgende optagelse af aminosyrerne i kroppen.
English: In STEMI patients undergoing primary PCI, standard pre-hospital adjunctive therapy should include clopidogrel and may include the early administration of UFH (See section 5.1).
Danish: Hos STEMI-patienter, der skal have foretaget primær PCI, skal supplerende standardbehandling før hospitalsindlæggelse omfatte clopidogrel og kan omfatte tidlig administration af UFH (jf. pkt.
English: • The most frequent serious and fatal adverse reactions are major haemorrhage (access site and non access-site bleeding, including intracranial haemorrhage) and hypersensitivity, including anaphylactic shock.
Danish: • De hyppigste alvorlige og letale bivirkninger er major blødning (blødning på indstiksstedet og andre steder, herunder også intrakraniel blødning) og overfølsomhed, herunder også anafylaktisk shock.
English: Hälsa Pharma GmbH Nikolaus Dürkopp-Str. 4A 33602 Bielefeld GERMANY
Danish: Hälsa Pharma GmbH Nikolaus Dürkopp-Str. 4A 33602 Bielefeld
English: Pharmacodynamic effects
Danish: Farmakodymanisk virkning
English: In REPLACE-2, bleeding data were collected separately from adverse events.
Danish: I REPLACE-2 blev blødningsdata indsamlet særskilt fra bivirkningsdata.
English: - The active substance is bivalirudin.
Danish: Aktivt stof: bivalirudin.
English: • In patients with moderate renal impairment (GFR 30-59 ml/ min) the infusion rate should be reduced to 1.4 mg/kg/h.
Danish: • Hos patienter med moderat nedsat nyrefunktion (GFR 30-59 ml/min) skal infusionshastigheden reduceres til 1,4 mg/kg/t.
English: Acute stent thrombosis
Danish: Akut stenttrombose
English: Unexplained decreases in haematocrit, haemoglobin or blood pressure may indicate haemorrhage.
Danish: Uforklarede fald i hæmatokrit, hæmoglobin eller blodtryk kan indikere blødning.