FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients who proceed to CABG surgery on pump, the intravenous infusion of bivalirudin should be continued until 1 hour prior to surgery after which the infusion should be discontinued and the patient treated with unfractionated heparin (UFH).
Danish: Patienter, der fortsætter til en koronararterie-graft-bypass (CABG) med brug af pumpe, skal fortsat have intravenøs infusion med bivalirudin op til 1 time før operation, hvorefter infusionen afbrydes, og patienten behandles med ufraktioneret heparin (UFH).
English: Approximately 23.3% of patients receiving bivalirudin experienced at least one adverse event and 2.1% experienced an adverse reaction.
Danish: Cirka 23,3 % af de patienter som fik bivalirudin oplevede mindst én uønsket hændelse og 2,1 % oplevede en lægemiddelrelateret bivirkning.
English: Co-administration with platelet inhibitors or anti-coagulants
Danish: Samtidig administration med trombocythæmmere eller antikoagulantia
English: If you need to have a coronary artery bypass graft operation, treatment with bivalirudin will either be stopped one hour before the operation or an additional dose of 0.5 mg/kg body weight will be given by injection followed by an infusion of 1.75 mg/kg body weight per hour for the duration of surgery.
Danish: Hvis du skal have en koronararterie-graft-operation, vil behandlingen med bivalirudin enten blive standset en time inden operationen, eller du vil modtage en ekstra dosis på 0,5 mg/kg legemsvægt som indsprøjtning efterfulgt af infusion med 1,75 mg/kg legemsvægt/time under hele operationen.
English: The HORIZONS Trial (Patients with STEMI undergoing primary PCI)
Danish: HORIZONS-studiet (patienter med STEMI, der fik foretaget primær PCI)
English: All of these bivalirudintreated patients received concomitant acetylsalicylic acid, all but 1 received clopidogrel and 15 also received a GP IIb/IIIa inhibitor.
Danish: Alle disse bivalirudinbehandlede patienter fik samtidig acetylsalicylsyre, og alle undtagen 1 fik clopidogrel, mens 15 også fik en GP IIb/IIIa-inhibitor.
English: Angiox 250 mg powder for concentrate bivalirudin
Danish: Angiox 250 mg pulver til koncentrat bivalirudin
English: ACUITY trial; bleeding events up to day 30 for the population of patients who received acetylsalicylic acid and clopidogrel as per protocol*
Danish: Blødningshændelser op til dag 30 for den population af patienter, som fik acetylsalicylsyre og clopidogrel ifølge protokol*
English: For patients who proceed to coronary artery bypass graft (CABG) surgery off pump, the intravenous infusion of bivalirudin should be continued until the time of surgery.
Danish: Patienter, der fortsætter til en koronararterie-graft-bypass (CABG) uden brug af pumpe, skal fortsat have intravenøs infusion af bivalirudin op til operationstidspunktet.
English: Uncommon side effects (may affect up to 1 in 100 people): • nausea (feeling sick) and/or vomiting (being sick)
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) • kvalme og/eller opkastning
English: • Angiox is contraindicated in patients with severe renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min) and in dialysis-dependent patients.
Danish: • Angiox er kontraindiceret til patienter med svær nyreinsufficiens (glomerulær filtrationsrate (GFR) < 30 ml/min) og til dialyseafhængige patienter.
English: Patients who are to be medically managed may continue the infusion of 0.25 mg/kg/h for up to 72 hours.
Danish: Patienter, der skal have medicinsk behandling, kan fortsætte med infusion af 0,25 mg/kg legemsvægt/time i op til 72 timer.
English: + GP IIb/IIIa inhibitor (%)
Danish: + GP IIb/IIIainhibitor (%)
English: The majority of these patients received concomitant acetylsalicylic acid and clopidogrel, and 10 out of 20 patients also received a GP IIb/IIIa inhibitor.
Danish: De fleste af disse patienter fik samtidig acetylsalicylsyre og clopidogrel, og 10 ud af 20 patienter fik også en GP IIb/IIIa-inhibitor.
English: ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for the overall population (ITT)
Danish: ACUITY-studiet: 30-dages endepunktsdata og 1 årsdata og forskelle mellem det sammensatte iskæmiske endepunkt og dens bestanddele overfor den samlede
English: Driving and using machines the effects of this medicine are known to be short-term.
Danish: Virkningen af medicinen er kortvarig.
English: Promethazine HCl
Danish: Promethazinhydrochlorid
English: Angiox is a powder for concentrate for solution for injection or infusion (powder for concentrate).
Danish: Angiox er et pulver til koncentrat til injektions- eller infusionsvæske, opløsning (pulver til koncentrat).
English: Healthcare professionals should refer to the Summary of Product Characteristics for full prescribing information.
Danish: Sundhedspersonalet skal se de fuldstændige oplysninger om ordinering i produktresuméet.
English: Withdraw 5 ml from the vial, and further dilute in a total volume of 5% 50 ml of glucose solution for injection, or sodium chloride 9 mg/ml (0.9%) solution for injection to give a final bivalirudin concentration of 5 mg/ml.
Danish: Udtræk de 5 ml opløsning fra hætteglasset, og fortynd i et totalt volumen på 5 % 50 ml glucoseopløsning til injektion eller en 9 mg/ml natriumchloridopløsning til injektion (0,9 %), således at den endelige koncentration af bivalirudin bliver 5 mg/ml.
English: Adverse events were more frequent in females and in patients more than 65 years of age in both the bivalirudin and the heparin-treated comparator groups compared to male or younger patients.
Danish: Bivirkninger var hyppigere hos kvinder og hos patienter over 65 år i forhold til hos mænd og hos yngre patienter, såvel i gruppen behandlet med bivalirudin som i sammenligningsgruppen behandlet med heparin.
English: • a known hypersensitivity to the active substance or to any of the excipients listed in section 6.1,
Danish: • en kendt overfølsomhed over for bivalirudin eller over for et eller flere af hjælpestofferne anført i pkt.
English: Major (non
Danish: Major blødning (ikke
English: In ACUITY, bleeding data were collected separately from adverse reactions.
Danish: I ACUITY blev blødningsdata indsamlet adskilt fra bivirkningsdata.
English: Do not administer intramuscularly.
Danish: Må ikke gives intramuskulært.
English: If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered and the ACT re-checked 5 minutes after the administration of the second bolus dose.
Danish: Hvis ACT-værdien er lavere end 225 sekunder, skal der indgives en ny bolusdosis på 0,3 mg/kg, og 5 minutter efter denne bolusdosis skal ACT måles igen.
English: Withdraw 5 ml from the vial, and further dilute in a total volume of 50 ml of glucose 5% solution for injection, or sodium chloride 9 mg/ml (0.9%) solution for injection to give a final bivalirudin concentration of 5 mg/ml.
Danish: Udtræk de 5 ml opløsning fra hætteglasset og fortynd i et totalt volumen på 50 ml ved tilsætning i enten en 5 % glucoseopløsning til injektion eller en 9 mg/ml natriumchloridopløsning til injektion (0,9 %), således at den endelige koncentration af bivalirudin bliver 5 mg/ml.
English: Swelling or pain in the groin or the arm, back pain, bruising, headache, coughing blood, pink or red urine, sweating, feeling faint or sick or dizzy due to low blood pressure may be signs of internal bleeding.
Danish: Hævelse eller smerter i lysken eller armen, rygsmerter, blå mærker, hovedpine, hoste blod op, lyserød eller rød urin,
English: There is no known antidote to bivalirudin, however, bivalirudin is haemo-dialysable.
Danish: Der er ingen kendt antidot til bivalirudin, men bivalirudin kan fjernes ved hæmodialyse.
English: Angiox should be initially reconstituted to give a solution of 50 mg/ml bivalirudin.
Danish: Angiox skal først rekonstitueres til en opløsning på 50 mg bivalirudin/ml.
English: - if you have, or have recently had, any bleeding from your stomach, intestines, bladder or other organs, for example, if you have noticed abnormal blood in your stools or urine (except from
Danish: - hvis du har eller for nylig har haft blødning fra mave, tarme, urinblære eller andre organer for eksempel opdaget ved blod i din urin eller afføring (ikke menstruation) - hvis dit blod har vanskeligt ved at størkne (nedsat antal blodplader) - hvis du har stærkt forhøjet blodtryk - hvis du har betændelse i hjertet - hvis du har svære nyreproblemer eller er dialysepatient.
English: The medicinal products incompatible with bivalirudin at higher concentrations are: dobutamine hydrochloride, famotidine, haloperidol lactate, labetalol hydrochloride, lorazepam and promethazine HCl.
Danish: De lægemidler, der er uforligelige med med bivalirudin i højere koncentrationer, er: Dobutaminhydrochlorid, famotidin, haloperidollactat, labetalolhydrochlorid, lorazepam og promethazin HC1.
English: For instructions for monitoring acute stent thrombosis, see section 4.4. d. Section 4.4 describes precautions for INR monitoring when bivalirudin is co-administered with warfarin.
Danish: 4.4 beskriver forsigtighedsregler for monitorering af INR, når bivalirudin administreres samtidig med warfarin.
English: - if you are allergic to bivalirudin or any of the other ingredients of this medicine (listed in section 6) or hirudins (other blood thinning medicines).
Danish: (angivet i punkt 6) eller hirudiner (andre blodfortyndende lægemidler).
English: Adverse reactions for bivalirudin are listed by system organ class in Table 1.
Danish: Bivirkninger for bivalirudin er anført efter systemorganklasse i Tabel 1.
English: In a clinical trial of 110 paediatric patients (neonates to <16 years of age) undergoing percutaneous intravascular procedures, the safety, pharmacokinetic and pharmacodynamic profile of bivalirudin was evaluated [TMC-BIV-07-01].
Danish: Bivalirudins sikkerhed og farmakokinetiske og farmakodynamiske profil blev undersøgt i en klinisk undersøgelse med 110 pædiatriske patienter (nyfødte til <16 år), som gennemgik perkutane intravaskulære procedurer [TMC-BIV-07-01].
English: Angiox is for injection, followed by infusion (drip), into a vein (never into a muscle).
Danish: Angiox gives i en blodåre (aldrig i en muskel) først som en indsprøjtning og derefter efterfulgt af infusion (drop).
English: Your doctor will decide how to treat you, including stopping the drug and monitoring for signs of ill effects.
Danish: Dette kan indbefatte afbrydelse af behandlingen og overvågning for tegn på bivirkninger.
English: • who are having surgery to treat blockages in their blood vessels (angioplasty and/or percutaneous coronary intervention - PCI).
Danish: • der skal have foretaget et kirurgisk indgreb, der skal forhindre tillukning af blodårerne (en ballonudvidelse og/eller en undersøgelse, der kaldes perkutan koronar intervention (PCI)).
English: In Arms B and C of the ACUITY trial, the recommended dose of bivalirudin was an initial postrandomisation intravenous bolus of 0.1 mg/kg followed by a continuous intravenous infusion of 0.25 mg/kg/h during angiography or as clinically warranted.
Danish: I ACUITY-studiets arm B og C var den rekommanderede bivalirudindosis en initialt postrandomiseret intravenøs bolus på 0,1 mg/kg legemsvægt efterfulgt af en kontinuerlig intravenøs infusion med 0,25 mg/kg legemsvægt/time under angiografi eller som klinisk påkrævet.
English: Angiox is contraindicated in patients with severe renal insufficiency (GFR<30 ml/min) and also in dialysis-dependent patients (see section 4.3).
Danish: Angiox er kontraindiceret hos patienter med alvorligt nedsat nyreinsufficiens (GFR<30 ml/min) samt hos dialyseafhængige patienter (se pkt.
English: Thrombocytopenia Anaemia
Danish: Trombocytopeni, anæmi
English: Brachytherapy
Danish: Brakyterapi
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN
English: Catheter thrombosis, Vascular pseudoaneurysm
Danish: rapporter med letal udgang AV-fistel Katetertrombose Vaskulær pseudoaneurisme
English: - After reconstitution (addition of 5 ml water for injections to the vial to dissolve the powder),
Danish: Efter rekonstitution (tilsætning af 5 ml vand til injektion i hætteglasset for at opløse pulveret) indeholder 1 ml 50 mg bivalirudin.
English: 30-day Composite ischaemia
Danish: 30-dage Sammensat iskæmi Død
English: The majority of these patients received concomitant acetylsalicylic acid and clopidogrel, and 6 out of the 10 patients also received a GP IIb/IIIa inhibitor.
Danish: Størstedelen af disse patienter var i samtidig behandling med acetylsalicylsyre og clopidogrel, og 6 ud af 10 patienter fik også en GP IIb/IIIa-hæmmer.
English: Injection site reactions (Injection site discomfort, Injection site pain, Puncture site reaction)
Danish: Reaktioner på administrationsstedet (gener ved administrationsstedet, smerter ved administrationsstedet, reaktioner ved punkturstedet)
English: Powder for concentrate for solution for injection or infusion (powder for concentrate).
Danish: Pulver til koncentrat til injektionsvæske eller infusionsvæske, opløsning (pulver til koncentrat).
English: For further information regarding the use of bivalirudin with or without a GP IIb/IIIa inhibitor, please see section 5.1.
Danish: Yderligere information om brug af bivalirudin med eller uden GPIIb/IIIa-inhibitor kan findes i pkt.
English: Additional anti-platelet therapy utilised in the study included acetylsalicylic acid and clopidogrel.
Danish: Patienter fra studiet, der fik blodfortyndende behandling, fik det i form af acetylsalicylsyre og clopidogrel.
English: • Approved dose in patients undergoing percutaneous coronary intervention (PCI): The licensed and approved dosing regimen of Angiox is an intravenous (IV) bolus injection of 0.75 mg/kg body weight followed immediately by an intravenous infusion at 1.75 mg/kg/hour for at least the duration of the PCI.
Danish: • Godkendt dosering til patienter, som skal have foretaget perkutan koronar intervention (PCI): Det autoriserede og godkendte Angiox-dosisregime er en intravenøs bolusinjektion på 0,75 mg/kg legemsvægt straks efterfulgt af intravenøs infusion af 1,75 mg/kg/time som minimum under hele PCI-proceduren.
English: Coronary artery thrombosis and coronary stent thrombosis with myocardial infarction, and catheter thrombosis have each been reported rarely.
Danish: Der er indberettet sjældne tilfælde af koronararterietrombose og koronar stenttrombose med myokardieinfarkt samt katetertrombose.
English: heparin  GP IIb/IIIa inhibitor (N=2,882)
Danish: heparin  GP IIb/IIIainhibitor (N=2.882)
English: Angiox should be administered with caution in breast-feeding mothers.
Danish: Angiox bør anvendes med forsigtighed til ammende kvinder.
English: Arm B bival +GP IIb/IIIa inhibitor (N=2,924)
Danish: Arm B bival +GP IIb/IIIainhibitor (N=2.924)
English: The following data are based on a clinical study of bivalirudin in 13,819 patients with ACS; 4,612 were randomised to bivalirudin alone, 4,604 were randomised to bivalirudin plus GP IIb/IIIa inhibitor and 4,603 were randomised to either unfractionated heparin or enoxaparin plus GP IIb/IIIa inhibitor.
Danish: 4.612 patienter blev randomiseret til behandling kun med bivalirudin; 4.604 blev randomiseret til behandling med bivalirudin og en GP IIb/IIIa-inhibitor og 4.603 blev randomiseret til behandling med enten ufraktioneret heparin eller enoxaprin og en GP IIb/IIIa-inhibitor.
English: 6%) of bivalirudin-treated patients and in 67 (3.9%) of patients treated with heparin plus a GP IIb/IIIa inhibitor.
Danish: I HORIZONS-studiet blev trombocytopeni rapporteret hos 26 (1,6 %) af de bivalirudinbehandlede patienter og hos 67 (3,9 %) af de patienter, som blev behandlet med heparin plus en GP IIb/IIIainhibitor.
English: Haematoma, Hypotension
Danish: Hæmatom Hypotension
English: • 0.1 mg/kg body weight as an intravenous injection, followed by an infusion (drip) into vein of 0.25 mg/kg body weight per hour for up to 72 hours.
Danish: 0,1mg/kg kropsvægt som intravenøs indsprøjtning, efterfulgt af infusion (drop) i en vene på 0,25 mg/kg kropsvægt i timen i op til 72 timer.
English: pvalue*
Danish: p-værdi*
English: The ACUITY Trial (Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI))
Danish: ACUITY-studiet (patienter med ustabil angina/myokardieinfarkt uden ST-elevation (UA/NSTEMI))
English: Powder for concentrate for solution for injection or infusion 10 vials
Danish: Pulver til koncentrat til injektionsvæske eller infusionsvæske, opløsning 10 hætteglas
English: Peritoneal haemorrhage, Retroperitoneal haematoma, Vomiting
Danish: Peritoneal blødning Retroperitonealt hæmatom Opkastning
English: Adverse drug reactions for bivalirudin are listed by system organ class in Table 1.The incidence of stent thrombosis within the first 24 hours was 1.5% in patients receiving bivalirudin versus 0.3% in patients receiving UFH plus GP IIb/IIIa inhibitor (p=0.0002).
Danish: Forekomsten af stenttrombose i løbet af de første 24 timer var 1,5 % hos patienter, som fik bivalirudin, versus 0,3 % hos patienter, som fik UFH plus GP IIb/IIIa-inhibitor (p=0,0002).
English: heparin  GP IIb/IIIa inhibitor (N=3,008)
Danish: heparin  GP IIb/IIIainhibitor (N=3.008)
English: Rash, Urticaria
Danish: Nyrer og urinveje
English: Reinfarction
Danish: Reinfarkt
English: Bival + GP IIb/IIIa inhibitor
Danish: Bivalirudin + GP IIb/IIIa-inhibitor
English: Following PCI, the reduced infusion dose of 0.25 mg/kg/h may be resumed for 4 to 12 hours as clinically necessary.
Danish: Efter PCI kan den reducerede dosis på 0,25 mg/kg legemsvægt/time fortsættes i 4-12 timer, hvor det er klinisk relevant.
English: Both minor and major bleeds were significantly less frequent with bivalirudin than the heparin plus GP IIb/IIIa inhibitor comparator group.
Danish: Både minor blødning og major blødning var signifikant mindre hyppig i bivalirudingruppen end i heparin- + GPIIb/IIIa-inhibitor-gruppen.
English: Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8C.
Danish: Den rekonstituerede opløsning kan opbevares i op til 24 timer ved 2 - 8 °C.
English: Rare side effects (may affect up to 1 in 1000 people)
Danish: Begge er sjældne (kan forekomme hos op til 1 ud af 1.000 personer).
English: Table 1.
Danish: Tabel 1:
English: Pharmacotherapeutic group: antithrombotic agents, Direct thrombin inhibitors, ATC code: B01AE06.
Danish: Farmakoterapeutisk klassifikation: Antitrombotiske midler, direkte virkende trombin-inhibitor.
English: The Medicines Company UK Ltd Tel : +421 (0 )268622610 alebo +421 (0) 268622610
Danish: Slovenská republika The Medicines Company UK Ltd Tel : +421 (0 )268622610 alebo +421 (0) 268622610
English: 2% in patients receiving bivalirudin versus 1.9% in patients receiving UFH plus GP IIb/IIIa inhibitor (p=0.1553).
Danish: Forekomsten af stenttrombose fra 24 timer til 30 dage var 1,2 % hos patienter, som fik bivalirudin, versus 1,9 % hos patienter, som fik UFH plus GP IIb/IIIa-inhibitor (p=0,1553).
English: • If you are taking blood thinners or medicines to prevent blood clots (anticoagulants or antithrombotics e.g. warfarin, dabigatran, apixaban, rivaroxaban, acetylsalicylic acid,
Danish: (antikoagulantia eller antitrombotika, f.eks. warfarin, dabigatran, apixaban, rivaroxaban,
English: Lyophilised (freeze-dried) powder: Do not store above 25C.
Danish: Frysetørret pulver: Må ikke opbevares ved temperaturer over 25 °C.
English: REPLACE-2 major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than 3 g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified.
Danish: REPLACE-2 major blødning blev defineret som forekomsten af ethvert af følgende: Intrakraniel blødning, retroperitoneal blødning, blodtab førende til transfusion af mindst to enheder helblod eller pakkede erytrocytter, eller blødning, der resulterer i et hæmoglobinfald på mere end 3 g/dl, eller et fald i hæmoglobin på mere end 4 g/dl (eller 12 % af hæmatokrit) uden identificeret blødningssted.
English: MI
Danish: d
English: If the medically managed patient proceeds to PCI, an additional bolus of 0.5 mg/kg of bivalirudin should be administered before the procedure and the infusion increased to 1.75 mg/kg/h for the duration of the procedure.
Danish: Hvis den medicinske patient fortsætter til PCI, bør der inden proceduren indgives en bolus yderligere på 0,5 mg bivalirudin per kg legemsvægt, og dosis skal øges til 1,75 mg/kg legemsvægt/time under selve proceduren.
English: • 0.75 mg/kg body weight as an intravenous injection, followed immediately by an infusion (drip) into vein of 1.75 mg/kg body weight, per hour for at least the duration of the PCI.
Danish: • 0,75 mg/kg legemsvægt som indsprøjtning i en blodåre, efterfulgt umiddelbart af infusion (drop) i en blodåre af 1,75 mg/kg legemsvægt i timen mindst så længe, som PCI'en varer.
English: ACUITY major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site haemorrhage requiring radiological or surgical intervention, ≥5 cm diameter haematoma at puncture site, reduction in haemoglobin concentration of ≥4 g/dl without an overt source of bleeding, reduction in haemoglobin concentration of ≥3 g/dl with an overt source of bleeding, re-operation for bleeding, use of any blood product transfusion.
Danish: ACUITY major blødning blev defineret som ethvert af følgende: Intrakraniel, retroperitoneal, intraokulær, blødning på adgangsstedet, der kræver radiologisk eller kirurgisk indgreb, ≥5 cm diameter hæmatom på punkturstedet, reduktion i hæmoglobinkoncentrationen på ≥4 g/dl uden identificeret blødningssted, reduktion i hæmoglobinkoncentrationen på ≥3 g/dl med identificeret blødningssted, transfusion af et hvilket som helst blodprodukt.
English: • Haematoma (bruising)
Danish: • blå mærker (hæmatom)
English: Patients with unstable angina/non-ST segment elevated myocardial infarction (UA/NSTEMI)
Danish: Patienter med ustabil angina/myokardieinfarkt uden ST-elevation (UA/NSTEMI).
English: The recommended starting dose of bivalirudin for medically managed patients with acute coronary syndrome (ACS) is an intravenous bolus of 0.1 mg/kg followed by an infusion of 0.25 mg/kg/h.
Danish: Til medicinske patienter med akut koronart syndrom (AKS) er den anbefalede startdosis bivalirudin en intravenøs bolus på 0,1 mg/kg legemsvægt efterfulgt af infusion af 0,25 mg/kg legemsvægt/time.
English: The infusion of 1.75 mg/kg body weight/hour may be continued for up to 4 hours post-PCI and at a reduced dose of 0.25 mg/kg body weight/hour for an additional 4 - 12 hours as clinically necessary.
Danish: Infusionen med 1,75 mg/kg legemsvægt/time kan forlænges i op til 4 timer efter PCI og med en reduceret dosis på 0,25 mg/kg legemsvægt/time i yderligere 4-12 timer, hvis det er klinisk relevant.
English: In any case, when bivalirudin is combined with a platelet inhibitor or an anticoagulant, clinical and biological parameters of haemostasis should be regularly monitored.
Danish: I alle tilfælde bør kliniske og biologiske hæmostaseparametre måles regelmæssigt, når bivalirudin kombineres med en trombocythæmmer og et antikoagulerende lægemiddel.