FrancophonIA/ELRC3.0 huggingface dataset:
English: TIMI scale major bleeding *clopidogrel pre-angiography or pre-PCI
Danish: TIMI-skala major blødning *clopidogrel præangiografi eller præ-PCI
English: Prolonged post PCI infusions of bivalirudin at recommended doses have not been associated with an increased rate of bleeding (see section 4.2).
Danish: Langvarig infusion af bivalirudin i de anbefalede doser efter PCI er ikke blevet forbundet med en øget blødningsfrekvens (se pkt.
English: The HORIZONS trial was a prospective, dual arm, single blind, randomised, multi-centre trial to establish the safety and efficacy of bivalirudin in patients with STEMI undergoing a primary PCI strategy with stent implantation with either a slow release paclitaxel-eluding stent (TAXUS™) or an otherwise identical uncoated bare metal stent (Express2™).
Danish: HORIZONS-studiet var et prospektivt, enkeltblindt, randomiseret, multicenterforsøg med to arme udført med henblik på at klarlægge bivalirudins sikkerhed og virkning hos patienter med STEMI, der får foretaget en primær PCI-med stentimplantation med enten en langsomt afgivende paclitaxelafgivende stent (TAXUS™) eller en i øvrigt identisk stent i bart metal uden overfladebehandling (Express2™).
English: In the HORIZONS study both major and minor bleeding occurred commonly (1/100 and <1/10).
Danish: I HORIZONS-studiet var både major og minor blødning almindelig (1/100 til <1/10).
English: Bleeding is more likely to occur when Angiox is used in combination with other anticoagulant or antithrombotic medicines (see section 2 ‘Taking other medicines').
Danish: Der er større sandsynlighed for, at blødning sker, når Angiox bruges sammen med andre antikoagulanter eller antitrombotiske lægemidler (se pkt.
English: Normal renal function (≥ 90ml/min) Mild renal impairment (60-89 ml/min) Moderate renal impairment (30-59 ml/min) Severe renal impairment (10-29 ml/min) Dialysis dependent patients (off-dialysis)
Danish: Normal nyrefunktion (≥ 90 ml/min) Let nedsat nyrefunktion (60 - 89 ml/min) Moderat nedsat nyrefunktion (30 - 59 ml/min) Svært nedsat nyrefunktion (10 - 29 ml/min) Dialyseafhængige patienter (der ikke er i dialyse)
English: For patients starting with percutaneous coronary intervention (PCI) the recommended dose is:
Danish: For patienter, der starter med perkutan koronar intervention (PCI), er den anbefalede startdosis:
English: • Do not use bivalirudin without first diluting it.
Danish: • Bivalirudin må ikke anvendes uden at være fortyndet.
English: The incidence of major bleeding is shown in Table 6.
Danish: Forekomsten af major blødning fremgår af Tabel 6.
English: Interaction studies have been conducted with platelet inhibitors, including acetylsalicylic acid, ticlopidine, clopidogrel, abciximab, eptifibatide, or tirofiban.
Danish: Interaktionsundersøgelser har været udført med blodplade-inhibitorer, herunder acetylsalicylsyre, ticlopidin, clopidogrel, abciximab, eptifibatid eller tirofiban.
English: Patients should be carefully monitored following primary PCI for signs and symptoms consistent with myocardial ischaemia.
Danish: Patienterne skal monitoreres omhyggeligt efter primær PCI for tegn og symptomer på myokardieiskæmi.
English: The REPLACE-2 Trial (Patients undergoing PCI)
Danish: REPLACE-2-studiet (patienter, der får foretaget PCI)
English: Occasionally, reactions can be more severe with throat itching, throat tightening, swelling of the eyes, face, tongue or lips, high pitched whistling during inhaling (stridor), difficulty breathing or exhaling (wheezes).
Danish: Reaktionerne kan blive alvorligere med kløe i halsen, strammende fornemmelse omkring halsen, hævelse af øjne, ansigt, tunge eller læber, pibende vejrtrækning (stridor) eller åndedrætsbesvær (hiven efter
English: The infusion may be followed by an infusion at a lower dose of 0.25 mg/kg body weight
Danish: Infusionen kan efterfølges af infusion af en lavere dosis på 0,25 mg/kg legemsvægt i
English: Angiox contains bivalirudin, a direct and specific thrombin inhibitor that binds both to the catalytic site and the anion-binding exosite of fluid-phase and clot-bound thrombin.
Danish: Angiox indeholder bivalirudin, som er en direkte og specifik trombininhibitor, som bindes både til det katalytiske site og det anionbindende exosite for både det frie trombin i opløsning og det fibrinbundne trombin i tromben.
English: Angiox is available in packs of 10 vials.
Danish: Angiox fås i pakninger med 10 hætteglas.
English: The advantage of bivalirudin over UFH/enoxaparin plus GP IIb/IIIa inhibitor in terms of bleeding events was only observed in the bivalirudin monotherapy arm.
Danish: Fordelen ved bivalirudin i forhold til UFH/enoxaparin plus GP IIb/IIIa-inhibitor for blødningshændelser blev kun observeret i monoterapiarmen med bivalirudin.
English: Intravenous infusion lines should be primed with bivalirudin to ensure continuity of drug infusion after delivery of the bolus.
Danish: Intravenøse infusionsslanger skal primes med bivalirudin for at sikre kontinuitet i lægemiddelinfusionen efter administration af bolusdosis.
English: Angiox contains sodium
Danish: Angiox indeholder natrium
English: The approved adult weight-based intravenous bolus dose of 0.75 mg/kg followed by an infusion of 1.75 mg/kg/hour was studied and pharmacokinetic/pharmacodynamic analysis found a response similar to that of adults, although weight-normalized clearance (ml/min/kg) of bivalirudin was higher in neonates than in older children and decreased with increasing age.
Danish: Den godkendte, vægtbaserede intravenøse bolusdosis til voksne på 0,75 mg/kg efterfulgt af infusion af 1,75 mg/kg/time blev undersøgt, og en farmakokinetisk/farmakodynamisk analyse fandt, at responset svarede til det, der sås hos voksne, selv om bivalirudins vægtnormaliserede clearance (ml/min/kg) var højere hos nyfødte end hos større børn og faldt i takt med stigende alder.
English: (GFR) < 30 ml/min) and in dialysis-dependent patients.
Danish: (GFR) < 30 ml/min) og til dialyseafhængige patienter.
English: Mannitol Sodium hydroxide 2% (for pH adjustment)
Danish: Mannitol Natriumhydroxid 2 % (til justering af pH).
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of chest, wheezing, hypotension and anaphylaxis.
Danish: Patienten bør informeres om de tidlige tegn på overfølsomhedsreaktioner som omfatter nældefeber, generaliseret urticaria, trykken for brystet, hvæsende vejrtrækning, hypotension og anafylaksi.
English: The bolus dose should be administered by a rapid intravenous push to ensure that the entire bolus reaches the patient before the start of the procedure.
Danish: Bolusdosis skal indgives hurtigt intravenøst for at sikre, at hele bolusdosis når patienten, før proceduren starter.
English: Arm C bival alone (N=4,612)
Danish: Arm C Bival alene (N=4.612)
English: The infusion dose should be initiated immediately after the bolus dose is administered, ensuring delivery to the patient prior to the procedure, and continued uninterrupted for the duration of the procedure.
Danish: Infusionen skal initieres straks efter administration af bolusdosis for at sikre dosering af patienten før proceduren og kontinuerligt uden afbrydelser under hele proceduren.
English: The primary analysis and results for ACUITY at 30-days and 1 year for the overall (ITT) population and for the patients that received acetylsalicylic acid and clopidogrel as per protocol (pre-angiography or pre-PCI) are shown in Tables 3 and 4.
Danish: De primære analyser og resultater af ACUITY ved 30 dage og 1 år er vist i Tabel 3 og 4 for den samlede population (ITT) og for patienter, der fik acetylsalicylsyre og clopidogrel som foreskrevet i protokollen (før angiografi eller før PCI).
English: The slide deck will contain the following key information:
Danish: Diassættet indeholder følgende vigtige oplysninger:
English: Serious adverse reactions were reported more frequently in the heparin plus GP IIb/IIIa group than the bivalirudin treated group.
Danish: Alvorlige bivirkninger blev rapporteret hyppigere i gruppen med heparin plus GP IIb/IIIa end i gruppen, der blev behandlet med bivalirudin.
English: Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience
Danish: Bivirkninger ved bivalirudin fra HORIZONS-, ACUITY- og REPLACE-2studierne samt fra erfaring efter markedsføring
English: The dose given depends on your weight and on the kind of treatment you are being given.
Danish: Din kropsvægt og typen af behandling afgør, hvor stor dosis du får.
English: Minor bleeding occurred very commonly (1/10) and major bleeding occurred commonly (1/100 and <1/10).
Danish: Minor blødning var meget almindelig ( 1/10), og major blødning var almindelig ( 1/100 og  1/10).
English: However, bivalirudin was not mutagenic or clastogenic in standard assays for such effects.
Danish: Dog har bivalirudin ikke vist hverken mutagen eller klastogen virkning i de gennemførte standardundersøgelser.
English: • For patients undergoing PCI, bivalirudin MUST be administered initially as an intravenous bolus followed immediately by an infusion.
Danish: • Til patienter, som gennemgår PCI, SKAL bivalirudin gives som en initial intravenøs bolus, der straks efterfølges af infusion.
English: Instructions for preparation
Danish: Vejledning til klargøring
English: Major bleeding occurred most frequently at the sheath puncture site.
Danish: Major blødning optrådte hyppigst på sheath-punkturstedet.
English: A total of 55.1% of patients receiving bivalirudin experienced at least one adverse event and 8.7% experienced an adverse drug reaction.
Danish: I alt 55,1 % af de patienter, som fik bivalirudin, oplevede mindst én ugunstig hændelse, og 8,7 % oplevede en bivirkning.
English: The reconstituted/diluted solution will be a clear to slightly opalescent, colourless to slightly yellow solution.
Danish: Den rekonstituerede/fortyndede opløsning vil være klar til let opaliserende og farveløs til svagt gul.
English: The other ingredients are mannitol and sodium hydroxide 2% (for pH adjustment)
Danish: Øvrige indholdsstoffer: mannitol og natriumhydroxid 2 % (til pH-justering)
English: Minor bleeding was defined as any observed bleeding event that did not meet the criteria as major.
Danish: Minor blødning blev defineret som enhver blødning, som ikke opfyldte kriterier for en major blødning.
English: Bivalirudin is rapidly distributed between plasma and extracellular fluid.
Danish: Bivalirudin fordeles hurtigt mellem blod og ekstracellulære væsker.
English: Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.
Danish: Angiox er indiceret som antikoagulans til voksne patienter, som skal have foretaget perkutan koronar intervention (PCI), herunder patienter med myokardieinfarkt med ST-elevation (STEMI), som skal have foretaget primær PCI.
English: A total of 3,602 patients were randomised to receive either bivalirudin (1,800 patients) or unfractionated heparin plus a GP IIb/IIIa inhibitor (1,802 patients).
Danish: I alt 3.602 patienter blev randomiseret til at få enten bivalirudin (1.800 patienter) eller ufraktioneret heparin plus en GP IIb/IIIa-inhibitor (1.802 patienter).
English: Per-protocol bivalirudin (N=2,994)
Danish: Per-protokol bivalirudin (N=2.994)
English: Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience are listed by system organ class in Table 1.
Danish: Bivirkninger ved bivalirudin fra HORIZONS-, ACUITY- og REPLACE-2-studierne samt fra erfaring efter markedsføring er anført efter systemorganklasse i Tabel 1.
English: WHAT YOU NEED TO KNOW BEFORE YOU USE ANGIOX
Danish: Det skal du vide, før du begynder at bruge Angiox
English: Famotidine
Danish: Famotidin
English: • Angiox must be administered as a bolus dose followed immediately by an intravenous infusion, even if a short PCI procedure is planned.
Danish: • Angiox skal administreres som bolusdosis, der straks efterfølges af intravenøs infusion, også hvis der er planlagt en kortvarig PCI-procedure.
English: This increased risk of acute stent thrombosis was observed during the first 4 hours following the end of the procedure among patients who either discontinued the infusion of bivalirudin at the end of the procedure or received a continued infusion at the reduced dose of 0.25 mg/kg/h (see section 4.2).
Danish: Den øgede risiko for akut stenttrombose sås i de første 4 timer efter afslutningen af indgrebet blandt patienter, hvor bivalirudin enten blev seponeret ved afslutningen af indgrebet, eller som fik fortsat infusion med en reduceret dosis på 0,25 mg/kg/time (se pkt.
English: Patients receiving acetylsalicylic acid & clopidogrel as per protocol* Arm A UFH/enox +GP IIb/IIIa inhibitor (N=2,842)
Danish: Patienter behandlet med acetylsalicylsyre & clopidogrel per protokolgruppe Arm A UFH/enox +GP IIb/IIIainhibitor (N=2.842)
English: Bleeding definitions and outcomes from the HORIZONS trial are shown in Table 6.
Danish: Blødningsdefinitioner og resultater fra HORIZONS-studiet fremgår af Tabel 6.
English: In vitro studies have indicated that bivalirudin inhibits both soluble (free) and clot-bound thrombin.
Danish: In vitro undersøgelser har vist, at bivalirudin hæmmer både opløst (frit) og fibrinbundet trombin i tromben.
English: Single bolus doses of bivalirudin up to 7.5 mg/kg have also been reported.
Danish: Bolusdoser op til 7,5 mg/kg med bivalirudin som enkeltdosis er også rapporteret.
English: The incidence of major and minor bleeding was significantly less in patients treated with bivalirudin versus patients treated with heparin plus a GP IIb/IIIa inhibitor.
Danish: Forekomsten af major og minor blødning var signifikant mindre hos patienter, som blev behandlet med bivalirudin, i forhold til patienter, som blev behandlet med heparin plus en GP IIb/IIIa-inhibitor.
English: The mean steadystate concentration of bivalirudin following a constant intravenous infusion of 2.5 mg/kg/h is 12.4 µg/ml.
Danish: Middel steady state koncentrationen af bivalirudin ved en konstant intravenøs infusion på 2,5 mg/kg legemsvægt/time er 12,4 μg/ml.
English: Reconstituted material should then be further diluted in a total volume of 50 ml to give a solution of 5 mg/ml bivalirudin.
Danish: Rekonstitueret materiale skal derefter fortyndes yderligere til en volumen på 50 ml, så der opnås en opløsning på 5 mg bivalirudin/ml.
English: Other less frequently observed bleeding sites with greater than 0.1% (uncommon) bleeding included “other” puncture site, retroperitoneal, gastrointestinal, ear, nose or throat.
Danish: Andre mindre hyppigt observerede blødningssteder med blødning med en frekvens på over 0,1 % (ikke almindelig) omfattede: ”andre” punktursteder, retroperitonealt, mave-tarmkanal, øre, næse eller hals.
English: Medicinal products with dose concentration incompatibilities to bivalirudin.
Danish: Lægemidler med koncentrationsafhængig uforligelighed med bivalirudin.
English: The bolus dose remains 0.75 mg/kg (or 0.5 mg/kg in patients who proceed to PCI after receiving bivalirudin pre-cath lab (UA/NSTEMI)).
Danish: Bolusdosis er fortsat 0,75 mg/kg (eller 0,5 mg/kg til patienter, som fortsætter til PCI efter indgift af bivalirudin præ-kat lab (UA/NSTEMI)).
English: The safety and efficacy of a bolus dose of bivalirudin without the subsequent infusion has not been evaluated and is not recommended even if a short PCI procedure is planned.
Danish: Sikkerheden og virkningen af en bolusdosis af bivalirudin uden efterfølgende infusion er ikke evalueret og frarådes - også ved en planlagt kortvarig PCI.
English: Compatible concentrations Incompatible concentrations
Danish: Forligelig dosiskoncentration Uforligelig dosiskoncentration
English: In the elderly, if their kidney function is decreased, the dose may need to be reduced.
Danish: Hos ældre kan det være nødvendigt at reducere dosis, hvis de har nedsat nyrefunktion.
English: Once the ACT value is greater than 225 seconds, no further monitoring is required provided the 1.75 mg/kg/h infusion dose is properly administered.
Danish: Når ACT-værdien er over 225 sekunder, er yderligere monitorering ikke nødvendig, forudsat at den fortsatte infusion administreres med 1,75 mg/kg/t.
English: Angiox is supplied as a lyophilised powder in 10 ml single use glass vials (Type 1) closed with a butyl rubber stopper and sealed with a crimped aluminum seal.
Danish: 10 ml engangshætteglas af type I glas lukket med en gummiprop (butyl) og en krympet aluminiumsring med forsegling.
English: If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered.
Danish: Hvis ACT-værdien efter 5 minutter er lavere end 225 sekunder, bør der indgives en ny bolusdosis på 0,3 mg/kg.
English: The incidence of both ACUITY-scale and TIMI-scale bleeding events to day 30 for the per protocol population are presented in Table 7.
Danish: Hyppigheden af blødningstilfælde ved både ACUITYskalaen og TIMI-skalaen ved dag 30 for per protokol-populationen er vist i Tabel 7.
English: The solution should be a clear to slightly opalescent, colourless to slightly yellow solution.
Danish: Opløsningen skal være klar til svagt opaliserende, farveløs til svagt gul.
English: The dose of bivalirudin used in HORIZONS was the same as that used in the REPLACE-2 study (0.75 mg/kg bolus followed by a 1.75 mg/kg body weight/hour infusion).
Danish: Den bivalirudindosis, der blev brugt i HORIZONS, var den samme, som blev anvendt i REPLACE-2studiet (bolus på 0,75 mg/kg efterfulgt af en infusion på 1,75 mg/kg legemsvægt/time).
English: Bivalirudin remains active and is not neutralised by products of the platelet release reaction.
Danish: Bivalirudin forbliver aktiv og bliver ikke neutraliseret af stoffer, der frigives ved trombocytaktivering.
English: White to off-white lyophilised powder.
Danish: Udseende: Hvidt til råhvidt pulver.
English: Approximately 30% of patients receiving bivalirudin experienced at least one adverse event and 3% experienced an adverse reaction.
Danish: Cirka 30 % af de patienter, som fik bivalirudin, oplevede mindst én uønsket hændelse, og 3 % oplevede en bivirkning.
English: Patients undergoing PCI, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI
Danish: Patienter, der skal have foretaget PCI, herunder patienter med myokardieinfarkt med ST-elevation (STEMI), der skal have foretaget primær PCI
English: The ACUITY trial was a prospective, randomised open-label, trial of bivalirudin with or without GP IIb/IIIa inhibitor (Arms B and C respectively) versus unfractionated heparin or enoxaparin with GP IIb/IIIa inhibitor (Arm A) in 13,819 high risk ACS patients.
Danish: ACUITY-studiet var et prospektivt, randomiseret open label-studie med bivalirudinbehandling med eller uden GP IIb/IIIa-inhibitor (henholdsvis arm B eller C) versus behandling med ufraktioneret heparin eller enoxaparin med GP IIb/IIIa-inhibitor (arm A).
English: Store in a refrigerator (2C-8C).
Danish: Opbevares i køleskab (2 °C - 8 °C).
English: • Anaemia (a low blood cell count)
Danish: • lavt antal blodlegemer (anæmi)
English: Dose adjustments for this age group should be on the basis of renal function, see section 4.2.
Danish: Dosisjustering i denne aldersgruppe bør foretages på basis af den enkeltes nyrefunktion, se pkt.
English: Bleeding definitions and outcomes from the REPLACE-2 trial are shown in Table 6.
Danish: Blødningsdefinitioner og -resultater fra REPLACE-2-studiet fremgår af Tabel 6.
English: Thrombosis includes coronary artery thrombosis (blood clot in the heart arteries or within a stent being felt as a heart attack which can also be fatal) and/or thrombosis in the catheter, both of which are rare (may affect up
Danish: Blodprop omfatter også blodprop i hjertets blodårer (koronararterietrombose eller i en stent, der føles som et hjerteanfald, der også kan være dødelig) eller blodprop i kateteret.
English: Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.
Danish: Angiox er også indiceret til behandling af voksne med ustabil angina/ myokardieinfarkt uden STelevation (UA/NSTEMI) enten i tilfælde af akut eller tidligt indgreb.
English: Acute stent thrombosis (<24 hours) has been observed in patients with STEMI undergoing primary PCI and has been managed by Target Vessel Revascularisation (TVR) (see sections 4.8 and 5.1).
Danish: Akut stenttrombose (<24 timer) er observeret hos patienter med STEMI, der skal have foretaget primær PCI, og er blevet behandlet med revaskularisering af det behandlede kar (TVR) (jf. pkt.
English: Intra-procedural thrombus formation has been observed during gamma brachytherapy procedures with Angiox.
Danish: Under behandling med Angiox er set trombedannelse under gamma-brakyterapi-procedurer.
English: C - A Risk diff. (95% CI)
Danish: C - A Forskel i risiko (95 % CI)
English: B - A Risk diff. (95% CI)
Danish: B - A Forskel i risiko (95 % CI)
English: Add 5 ml sterile water for injections to one vial of Angiox and swirl gently until completely dissolved and the solution is clear.
Danish: Tilsæt 5 ml sterilt vand til et hætteglas Angiox, og vend hætteglasset forsigtigt, indtil alt tørstof er opløst, og opløsningen syner helt klar.
English: The incidence of both ACUITY-scale and TIMI-scale bleeding events up to day 30 for the intent-totreat population is presented in Table 6.
Danish: Hyppigheden af blødningstilfælde ved både ACUITY-skalaen og TIMI-skalaen frem til dag 30 for intent-to-treat-populationen er vist i Tabel 6.
English: Reperfusion injury (no or slow reflow), Contusion a. ADRs identified in post-marketing experience b. Compartment syndrome has been reported as a complication of forearm haematoma following administration of bivalirudin via the radial access route in post-marketing experience c. Further detail regarding stent thrombosis is provided in section 4.8: The HORIZONS Trial (Patients with STEMI undergoing primary PCI).
Danish: Reperfusionsskade (intet eller langsomt reflow) Kontusion a. Bivirkninger påvist efter markedsføring b. Kompartmentsyndrom er rapporteret efter markedsføring som en komplikation ved underarmshæmatom efter administration af bivalirudin via arteria radialis c. Stenttrombose er beskrevet nærmere i pkt.
English: ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for patients that received acetylsalicylic acid and clopidogrel as per protocol*
Danish: ACUITY studiet; 30-dages endepunkt og 1 årsdata og forskelle mellem det sammensatte iskæmiske endepunkt og dets bestanddele overfor patienter der blev behandlet med acetylsalicylsyre og clopidogrel per protokolgruppe*
English: Myocardial infarction,
Danish: Myokardieinfarkt Uplanlagt revask.
English: Anaphylaxis, including anaphylactic shock with fatal outcome has been reported very rarely (≤1/10,000) in post-marketing experience (see section 4.8).
Danish: I post-marketing rapporter er anafylaksi, herunder anafylaktisk chok med dødelig udgang, rapporteret meget sjældent (<1/10.000) (se pkt.
English: Platelets, bleeding and clotting
Danish: Blodplader, blødning og størkning
English: oC.
Danish: Anv.
English: Reconstituted solution: Store in a refrigerator (2-8C).
Danish: Den rekonstituerede opløsning: Opbevares i køleskab (2 - 8 C).
English: Healthcare providers are recommended to refer to the Angiox Summary of Product Characteristics for full information on dosing.
Danish: Sundhedspersonale henvises til produktresuméet for Angiox, der indeholder alle oplysninger om dosering.
English: The analysis and results for the HORIZONS trial at 30 days for the overall (ITT) population is shown in Table 2.Results at 1 year were consistent with results at 30 days.
Danish: Analysen og resultaterne for HORIZONS-studiet efter 30 dage for den samlede (ITT) population fremgår af Tabel 2.
English: Arm C bival alone (N=2,911)
Danish: Arm C bival alene (N=2.911)