FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: 30 day Composite MACE
Danish: Sammensat, 30 dage MACE
English: The educational materials will be used in all member states for both initial training and re-education in the event of reports of bolus only dosing without subsequent infusion.
Danish: Informationsmaterialet vil blive benyttet i alle medlemslande til både indledende uddannelse og genuddannelse ved indberetninger om behandling med bolusdosis alene uden efterfølgende infusion.
English: Angiox should not be used during pregnancy unless the clinical condition of the woman requires treatment with bivalirudin.
Danish: Angiox bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand nødvendiggør behandling med bivalirudin.
English: In the case of shock, the current medical standards for shock treatment should be applied.
Danish: I tilfælde af chok skal gældende standard for shockbehandling initieres.
English: Pharmacodynamic models indicated that this effect is due to a higher baseline ACT in neonates and infants than in older children.
Danish: Farmakodynamiske modeller indikerede, at denne virkning skyldes en højere ACT ved baseline hos nyfødte og spædbørn end hos større børn.
English: Ischaemic Components All cause death
Danish: Iskæmiske komponenter Alle dødsårsager
English: This dosing pattern was associated with increased in-hospital ischaemic events (MACE).
Danish: Dette doseringsmønster var forbundet med øgede iskæmiske episoder på hospitalet (MACE).
English: There are no or limited data from the use of bivalirudin in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af bivalirudin til gravide kvinder.
English: Approximately 66% of patients were pre-treated with unfractionated heparin.
Danish: Omtrent 66 % af patienterne var tidligere blevet behandlet med ufraktioneret heparin.
English: Comparison of the single and repeated dose studies revealed that toxicity was related primarily to duration of exposure.
Danish: Sammenligning af enkeltdosis- og flerdosisundersøgelser viste, at toksiciteten primært var relateret til varigheden af behandlingen.
English: HORIZONS 30-day study results (intent-to-treat population)
Danish: HORIZONS 30-dages forsøgsresultater (intent-to-treat-population)
English: Elimination follows a first order process with a terminal half-life of 25  12 minutes in patients with normal renal function.
Danish: Eliminationen følger en 1. ordens- proces med en terminal halveringstid på 25 ± 12 minutter hos patienter med normal nyrefunktion.
English: The steady-state volume of distribution is 0.1 l/kg.
Danish: Steady state distributionsvolumen er 0,1 l/kg.
English: The most frequent event was a haematoma <5 cm at puncture site.
Danish: Den hyppigste hændelse var et hæmatom på <5 cm ved punkturstedet.
English: There was no statistically significant difference in the rates of stent thrombosis between treatment arms at 30 days (p=0.3257) and 1 year (p=0.7754).
Danish: Der var ingen statistisk signifikant forskel i hyppigheden af stenttrombose mellem behandlingsarmene efter 30 dage (p=0,3257) og 1 år (p=0,7754).
English: • Bleeding and bruising at the puncture site (after PCI treatment) may be painful.
Danish: • Blødning eller blå mærker på punktursted (efter PCI-behandling) kan være smertefulde.
English: Clinical trials in a small number of patients have provided limited information about the use of Angiox in patients with HIT/HITTS.
Danish: Kliniske studier med et lille antal patienter har givet begrænset viden om brug af Angiox hos patienter med HIT/HITTS.
English: No dose adjustment is needed.
Danish: Justering af dosis er ikke nødvendig.
English: The ACT vs concentration data suggest a trend for a lower concentration response curve for adults as compared to older children (6 years to < 16 years) and younger children (2 years to <6 years), and for older children compared to infants (31 days to <24 months) and neonates (birth to 30 days).
Danish: ACT versus koncentration tyder på en tendens til en lavere koncentration-responskurve for voksne sammenlignet med større børn (6 år til <16 år) og mindre børn (2 år til <6 år), og for større børn sammenlignet med spædbørn (31 dage til <24 måneder) og nyfødte (fødsel til 30 dage).
English: Approximately 77% of patients had recurrent ischaemia, approximately 70% had dynamic ECG changes or elevated cardiac biomarkers, approximately 28% had diabetes and approximately 99% of patients underwent angiography within 72 hours.
Danish: Cirka 77 % af patienterne havde tilbagevendende iskæmi, cirka 70 % havde dynamiske EKG-forandringer eller forhøjede kardiale biomarkører, cirka 28 % havde diabetes og cirka 99 % af alle patienter undergik en angiografi inden for 72 timer.
English: Throughout your treatment, the doctor will check you for any signs of bleeding.
Danish: Under behandlingen vil din læge undersøge dig for tegn på blødning.
English: There is no known antidote to bivalirudin but its effect wears off quickly (T½ is 25 ± 12 minutes).
Danish: Der er ingen kendt antidot til bivalirudin, men virkengen aftager hurtigt (T½ er 25 ± 12 minutter).
English: Angiox is contraindicated in patients with:
Danish: Angiox er kontraindiceret hos patienter med:
English: In order to ensure the correct use of Angiox and to avoid medication errors, the MAH shall ensure that all prescribers who are expected to prescribe/use Angiox are provided with training on dosing and administration.
Danish: For at sikre korrekt anvendelse af Angiox og for at undgå medicineringsfejl skal indehaveren af markedsføringstilladelsen sikre, at alle, som forventes at ordinere/bruge Angiox, oplæres i dosering og administration.
English: 3, representing a ≥50% decrease in platelets from baseline.
Danish: 3, hvilket udgjorde et fald på ≥50 % i trombocyttal i forhold til baseline.
English: An increase in the activated clotting time (ACT) may be used as an indication that a patient has received bivalirudin.
Danish: Stigning i aktiveret koagulationstid (ACT) kan benyttes som tegn på, at en patient har fået bivalirudin.
English: Toxicity in animals upon repeated or continuous exposure (1 day to 4 weeks at exposure levels of up to 10 times the clinical steady state plasma concentration) was limited to exaggerated pharmacological effects.
Danish: Toksicitet hos dyr udsat for gentagen eller kontinuerlig eksponering (fra 1 dag til 4 ugers behandlingsniveau med op til 10 gange klinisk steady state plasmakoncentration) var begrænset til overdreven farmakologisk virkning.
English: The corresponding clearance is about 3.4  0.5 ml/min/kg.
Danish: Den relaterede clearance er cirka 3,4 ± 0,5 ml/min/kg.
English: Following angiographic assessment, patients were triaged to either medical management (33%), PCI (56%) or CABG (11%).
Danish: Efter angiografi blev patienterne enten henvist til medicinsk behandling (33 %), PCI (56 %) eller CABG (11 %).
English: • In the ImproveR registry bolus dosing (without subsequent infusion) was observed in EU clinical practice.
Danish: • I ImproveR-registeret blev bolusdosering (uden efterfølgende infusion) observeret i klinisk praksis i EU.
English: • if you have been treated before with medicines similar to Angiox (e.g. lepirudin).
Danish: • hvis du tidligere er blevet behandlet med medicin, der ligner Angiox (f.eks. lepirudin).
English: Relative Risk [95% CI]
Danish: Relativ risiko [95 % CI]
English: • active bleeding or increased risk of bleeding because of haemostasis disorders and/or irreversible coagulation disorders
Danish: • aktiv blødning eller øget blødningsrisiko på grund af hæmostaseforstyrrelser og/eller irreversible koagulationsforstyrrelser
English: Clearance is reduced by approximately 20% in patients with moderate or severe renal impairment, and 80% in dialysis-dependent patients (Table 8).
Danish: Clearance er reduceret med cirka 20 % hos patienter med moderat eller svært nedsat nyrefunktion, og med 80 % hos dialyseafhængige patienter (Se Tabel 8).
English: After being treated with Angiox for a cardiac event, you should stay in the hospital for at least 24 hours and you should be monitored for any symptoms or signs similar to the ones that remind you of your cardiac event and resulted in your hospitalisation.
Danish: Når du er blevet behandlet med Angiox efter en hjertehændelse, skal du blive på hospitalet i mindst 24 timer, og du skal overvåges for symptomer eller tegn, der ligner dem, du havde i forbindelse med din hjertehændelse, og som medførte, at du blev indlagt på hospitalet.
English: The MAH shall agree on the dosing card together with a communication plan, with the National Competent Authority in each Member State prior to distribution in the Member State.
Danish: Indehaveren af markedsføringstilladelsen skal blive enig om doseringskortet samt en kommunikationsplan med medlemsstatens relevante myndighed, før det distribueres i medlemsstaten.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8C unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den rekonstituerede/fortyndede opløsning ikke anvendes straks, er opbevaringstid og -forhold før anvendelse brugerens eget ansvar og bør normalt ikke overskride 24 timer ved 2 til 8 °C, medmindre rekonstitution/fortynding er blevet foretaget under kontrollerede og validerede aseptiske forhold..
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Data fra dyreforsøg er utilstrækkelige hvad angår virkningen på graviditet, embryonal/føtal udvikling, fødsel og postnatal udvikling (se pkt.
English: Your warfarin blood test result (INR test) may be affected by Angiox.
Danish: Resultatet af din warfarinblodprøve (INR-prøve) kan påvirkes af Angiox.
English: • Allergic reactions,- are uncommon (may affect up to 1 in 100 people) and usually not serious but can become severe under some circumstances, and in rare cases may be fatal due to low blood pressure (shock).
Danish: • Allergiske reaktioner er ikke almindelige (kan forekomme hos op til 1 ud af 100 personer) og normalt ikke alvorlige, men kan blive alvorlige under visse omstændigheder og kan i sjældne tilfælde medføre døden på grund af lavt blodtryk (shock).
English: High risk patient characteristics of the ACUITY population that mandated angiography within 72 hours were balanced across the three treatment arms.
Danish: Højrisiko-patienter i ACUITY-populationen, som havde brug for en angiografi inden for 72 timer, blev ligeligt fordelt ud på de tre behandlingsarme.
English: In the event of major bleeding, treatment with bivalirudin should be immediately discontinued.
Danish: I tilfælde af alvorlig blødning skal behandling med bivalirudin afbrydes straks.
English: It is unknown whether bivalirudin is excreted in human milk.
Danish: Det vides ikke, om bivalirudin udskilles i human mælk.
English: Other frequently reported adverse events were decreased pedal pulse, catheter site haemorrhage, abnormal pulse, and nausea (8.2%, 7.3%, 6.4% and 5.5%, respectively).
Danish: Andre hyppigt rapporterede bivirkninger var nedsat fodpuls, blødning ved kateterstedet, unormal puls og kvalme (henholdsvis 8,2 %, 7,3 %, 6,4 % og 5,5 %).
English: Pulmonary haemorrhage Dyspnoea a
Danish: Pulmonal blødning Dyspnø a
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction.
Danish: De prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og reproduktionstoksicitet.
English: In all clinical studies bleeding data were collected separately from adverse reactions and are summarised in Table 6 together with the bleeding definitions used for each study.
Danish: I alle kliniske forsøg blev blødningsdata indsamlet separat fra andre bivirkninger, og disse er opsummeret i Tabel 6 sammen med de blødningsdefinitioner, der anvendes i hvert forsøg.
English: Rarely this may require surgery to repair the blood vessel in the groin (fistula, pseudoaneurysm) (may affect up to 1 in 1,000 people).
Danish: Det kan i sjældne tilfælde kræve operation for at reparere blodåren i lysken (fistel, pseudoaneurysme) (kan forekomme hos op til 1 ud af 1.000 personer).
English: Pharmacokinetics have been evaluated in elderly patients as part of a renal pharmacokinetic study.
Danish: Farmakokinetik er undersøgt hos ældre som en del af en nyrefarmakokinetik-undersøgelse.
English: All 5 events were associated with additional cardiac procedures employing heparin anticoagulation (n=3) or with infections (n=2).
Danish: Alle 5 hændelser var forbundet med yderligere kardiale procedurer, hvor heparin blev anvendt som antikoagulans (n=3), eller med infektioner (n=2).
English: Do not use Angiox
Danish: Brug ikke Angiox:
English: As Angiox is a hospital only medicine, storage of Angiox is the responsibility of healthcare professionals.
Danish: Eftersom Angiox kun gives på hospitalet, er opbevaring af Angiox sundhedspersonalets ansvar.
English: Thrombotic (9/110, 8.2%) and major bleeding events (2/110, 1.8%) were observed in the study.
Danish: Der blev observeret trombotiske (9/110; 8,2 %) og større blødningshændelser (2/110; 1,8 %) i undersøgelsen.
English: Caution should be exercised in patients previously treated with lepirudin who had developed lepirudin antibodies.
Danish: Forsigtighed bør udvises hos patienter som tidligere har været behandlet med lepirudin og som har dannet antistoffer mod lepirudin.
English: The intravenous infusion may continue at this dose for up to 4 hours after the PCI and for STEMI patients (those with a severe type of heart attack) it should continue at this dose for up to 4 hours.
Danish: Den intravenøse infusion kan fortsætte med denne dosis i op til 4 timer efter PCI'en, og hos STEMIpatienter (patienter, der har en alvorlig type hjerteanfald) bør den fortsætte med denne dosis i op til 4 timer.
English: REPLACE-2 study results: 30-day endpoints (intent-to-treat and per-protocol populations
Danish: REPLACE-2-studieresultater: 30-dages endepunkt (intent-to-treat- og per-protokolpopulation)
English: • Reperfusion injury (no or slow reflow): impaired flow in the heart arteries after they have been reopened
Danish: • intet eller langsomt tilbageløb (reperfusionsskade): dårlig blodstrøm i hjertets blodårer, efter at de har været åbnet igen
English: Treatment-emergent positive bivalirudin antibodies are rare and have not been associated with clinical evidence of allergic or anaphylactic reactions.
Danish: Behandlingsrelaterede positive bivalirudinantistoffer er sjældne og har ikke været forbundet med kliniske tilfælde af allergiske eller anafylaktiske reaktioner.
English: If you get any of the following, (potentially less serious), side effects:
Danish: Hvis du får nogen af følgende (potentielt mindre alvorlige) bivirkninger:
English: The dosing cards will contain the following key information:
Danish: Doseringskortene indeholder følgende vigtige oplysninger:
English: The doctor will check the solution and will discard it, if it contains particles or is discoloured.
Danish: Lægen vil kontrollere opløsningen inden brug og smide den ud, hvis den indeholde partikler eller er misfarvet.
English: In Arm A of the ACUITY trial, UFH or enoxaparin was administered in accordance with the relevant guidelines for the management of ACS in patients with UA and NSTEMI.
Danish: I ACUITY-studiets arm A blev UFH eller enoxaparin administreret i henhold til relevante retningslinjer for AKS-patienter med UA og NSTEMI.
English: The arterial sheath can be removed 2 hours after discontinuation of the bivalirudin infusion without anticoagulation monitoring.
Danish: Den arterielle sheath kan fjernes 2 timer efter afsluttet bivalirudininfusion uden monitorering af antikoagulationen.
English: Thus, bivalirudin initially acts as a complete non-competitive inhibitor of thrombin, but transitions over time to become a competitive inhibitor enabling initially inhibited thrombin molecules to interact with other clotting substrates and to coagulation if required.
Danish: Dermed virker bivalirudin initialt som en komplet non-kompetitiv trombin-inhibitor, men ændrer sig over tid til at blive en kompetetiv inhibitor, som muliggør, at initialt inhiberede trombinmolekyler kan interagere med andre koagulationsubstrater og medvirke til koagulation om nødvendigt.
English: Pharmacokinetic parameters for bivalirudin in patients with normal and impaired
Danish: Farmakokinetiske parametre for bivalirudin hos patienter med normal og nedsat
English: Any unused solution should be discarded.
Danish: Ikke anvendt opløsning skal kasseres.
English: Two deaths occurred after acute stent thrombosis, 1 in each arm of the study.
Danish: Der forekom to dødsfald efter akut stenttrombose, 1 i hver arm af forsøget.
English: • subacute bacterial endocarditis
Danish: • subakut bakteriel endocarditis
English: Acute cardiac events
Danish: Akutte kardielle tilfælde
English: • with chest pain due to heart disease (acute coronary syndromes - ACS)
Danish: • med brystsmerter som skyldes en hjertesygdom (akut koronar syndrom - AKS)
English: Where insufficient ACT increase is observed, the possibility of medication error should be considered, for example inadequate mixing of Angiox or intravenous equipment failures.
Danish: Hvis stigningen i ACT er utilstrækkelig, skal det overvejes, om der er sket en medicineringsfejl, f.eks. utilstrækkelig blanding af Angiox eller fejl i det intravenøse udstyr.
English: • if you are having radiation treatment in the vessels that supply blood to the heart (treatment called beta or gamma brachytherapy).
Danish: • hvis du får strålebehandling af de blodkar, som forsyner hjertet med blod (behandlingen kaldes for beta- eller gamma-brakyterapi).
English: Although most bleeding associated with bivalirudin occurs at the site of arterial puncture in patients undergoing PCI, haemorrhage can occur at any site during therapy.
Danish: Selv om de fleste blødningstilfælde relateret til bivalirudin opstår ved arteriepunkturstedet hos patienter, som får foretaget PCI, kan blødning opstå hvor som helst under behandlingen.
English: Angiox has no or negligible influence on the ability to drive and use machines.
Danish: Angiox påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Treatment should be stopped if bleeding is observed or suspected.
Danish: Behandlingen bør stoppes ved observeret blødning eller mistanke om blødning.
English: Data from 366 patients indicates that the ACT is unaffected by concomitant treatment with a GP IIb/IIIa inhibitor.
Danish: Data fra 366 patienter viser, at ACT ikke påvirkes af samtidig behandling med en GP IIb/IIIa-inhibitor.
English: Based on the short half-life of bivalirudin (25 minutes), failure to initiate an infusion following the Angiox bolus will result in a plasma concentration that is below the required level within minutes
Danish: På grund af bivalirudins korte halveringstid (25 minutter) vil manglende initiering af en infusion efter Angiox-bolus i løbet af få minutter medføre en plasmakoncentration, der er under det krævede niveau.
English: • Thrombosis (blood clot) is an uncommon side effect (may affect up to 1 in 100 people) which may result in serious or fatal complications such as heart attack.
Danish: • Blodprop (trombose) er en ikke almindelig bivirkning (kan forekomme hos op til 1 ud af 100 personer), som kan resultere i alvorlige eller dødelige komplikationer som f.eks. hjerteanfald.
English: In cases of overdose, treatment with bivalirudin should be immediately discontinued and the patient monitored closely for signs of bleeding.
Danish: I tilfælde af overdosering skal behandling med bivalirudin straks afbrydes, og patienten skal overvåges nøje for tegn på blødning.
English: Major Adverse Cardiac/Ischaemic Events (MACE) was defined as the occurrence of any of the following; death, reinfarction, stroke or ischaemic target vessel revascularisation.
Danish: Major Adverse Cardiac/Ischaemic Events (MACE) blev defineret som forekomst af ethvert af følgende: Død, reinfarkt, apopleksi eller iskæmi trods revaskularisering af det behandlede kar.
English: Educational material includes a slide deck presentation, dosing cards as described in the risk minimization measures in the RMP, and a copy of the SmPC.
Danish: Informationsmaterialet omfatter en diaspræsentation, doseringskort som beskrevet i foranstaltningerne til risikominimering i RMP samt kopi af produktresuméet.
English: The clinical utility of ACT in neonates and children should be considered with caution considering their developmental haematological state.
Danish: Den kliniske anvendelighed af ACT hos nyfødte og børn skal nøje overvejes under hensyntagen til deres hæmatologiske stade rent udviklingsmæssigt.
English: • Angina or chest pain
Danish: • angina eller brystsmerter
English: In clinical study TMC-BIV-07-01, the pharmacodynamic response as measured by ACT was consistent with adult studies.
Danish: I det kliniske studie TMC-BIV-07-01 var det farmakodynamiske respons, målt ved ACT, det samme som i undersøgelser hos voksne.
English: • Tabulated information on dosing by body weight of patient.
Danish: • Tabel med dosering efter patientens legemsvægt.
English: The systemic clearance of bivalirudin decreases with glomerular filtration rate (GFR).
Danish: Den systemiske clearance af bivalirudin falder med den glomerulære filtrationsratio (GFR).
English: Uncommonly (may affect up to 1 in 100 people) the number of blood platelets may be low which can worsen any bleeding.
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) kan antallet af blodplader være lavt, hvilket kan forværre enhver blødning.
English: *clopidogrel pre-angiography or pre-PCI
Danish: *clopidogrel præ-angiografi eller præ-PCI
English: They may begin with limited symptoms such as itching, redness of the skin, rash or small bumps on the skin.
Danish: De kan begynde med begrænsede symptomer, såsom kløe, hudrødme, udslæt eller små buler på huden.
English: The ACT increased in all patients - from neonates to older children as well as adults- with increasing bivalirudin concentrations.
Danish: ACT steg hos alle patienter - fra nyfødte til større børn samt voksnei takt med stigende koncentration af bivalirudin.
English: Undesirable effects that resulted from prolonged physiological stress in response to a non-homeostatic state of coagulation were not seen after short exposure comparable to that in clinical use, even at much higher doses.
Danish: Bivirkninger forårsaget af forlænget fysiologisk stress som resultat af en non-hæmostatisk koagulationstilstand forekom ikke efter kort tids behandling - hvilket er sammenligneligt med klinisk brug - selv ved meget højere doser.
English: Angiox should be used with caution during beta brachytherapy procedures.
Danish: Angiox bør anvendes med forsigtighed under beta-brakyterapi-procedurer.
English: Bivalirudin is intended for short-term administration and therefore no data on the long-term carcinogenic potential of bivalirudin are available.
Danish: Bivalirudin er beregnet til korttidsbehandling, og der foreligger derfor ikke data på langtidskarcinogenicitets-potentialet af bivalirudin.