FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 2: Summary of dosing for reversal of apixaban
Danish: Tabel 2: Oversigt over dosering til revertering af apixaban
English: Dose-dependent increases in coagulation markers F1+2, TAT, and D-dimers after administration of andexanet alfa were observed, but these markers were not measured in patients enrolled in the ANNEXA-4 study, and their relevance in bleeding patients is not known.
Danish: Der blev observeret dosisafhængige stigninger i koagulationsmarkørerne F1+2, TAT og D-dimerer efter administration af andexanet alfa, men disse markører blev ikke målt hos patienter, der deltog i ANNEXA-4 studiet, og deres relevans hos blødende patienter er ikke kendt.
English: What you need to know before you receive Ondexxya Do not use Ondexxya:
Danish: Det skal du vide, før du får Ondexxya Brug ikke Ondexxya:
English: The volume of distribution at steady state (Vdss) and volume of distribution (Vd) at sub-therapeutic levels decreased with dose, consistent with the saturation of a high-affinity compartment, likely to reflect binding to endothelial cell bound TFPI, the only endogenous molecule known to bind andexanet alfa.
Danish: Fordelingsvolumenet ved steady-state (Vdss) og fordelingsvolumenet (Vd) ved subterapeutiske niveauer faldt med dosis svarende til mætningen af et højaffinitetsrum, hvilket sandsynligvis afspejler binding til endotelcellebundet TFPI, som er det eneste endogene molekyle, man ved, binder andexanet alfa.
English: 345 andexanet alfa-treated healthy subjects were tested for antibodies cross reacting with andexanet alfa and antibodies to factor X and FXa.
Danish: 345 andexanet alfa-behandlede raske forsøgspersoner blev testet for antistoffer, der krydsreagerede med andexanet alfa, og antistoffer mod faktor X og FXa.
English: Most patients had previously received either apixaban (194/352; 55.1%) or rivaroxaban (128/352; 36.4%), and experienced either an ICH (230/352; 65.3%) or a gastrointestinal (GI) bleed (94/352; 26.7%).
Danish: De fleste patienter havde tidligere fået enten apixaban (194/352, 55,1 %) eller rivaroxaban (128/352, 36,4 %) og oplevede enten en ICH (230/352, 65,3 %) eller en gastrointestinal (GI) blødning (94/352, 26,7 %).
English: In clinical trials of patients with life-threatening bleeding, fever and stroke may affect up to 1 in 10 people; transient ischaemic attack (TIA), heart attack, and blood clots in the legs or lungs may affect up to 1 in 100 people (uncommon side effects).
Danish: I kliniske studier med patienter med livstruende blødning kan feber og apopleksi forekomme hos op til 1 ud af 10 personer, og transitorisk iskæmisk attak (TIA), hjerteantald og blodpropper i ben eller lunger kan forekomme hos op til 1 ud af 100 personer (ikke almindelige bivirkninger).
English: Restarting antithrombotic therapy
Danish: Genstart på antitrombotisk terapi
English: In order to further confirm the efficacy and safety, the MAH should submit an updated PK/PD model using all previously incorporated data (from studies 11-501, 12-502, 14503, 14-504, and 14-506) as well as newly incorporated data from study 16-512 (PKPD study of Generation 2 andexanet versus Generation 1), study 16-508 (PK-PD study of andexanet in individuals of Japanese ethnicity), and study 14-505 (ANNEXA-4).
Danish: Indehaveren af markedsføringstilladelsen skal til yderligere bekræftelse af virkningen og sikkerheden indsende en opdateret PK/PD-model, der anvender alle tidligere inkorporerede data (fra studierne 11-501, 12-502, 14-503, 14-504 og 14-506) samt ny-inkorporerede data fra studie 16-512 (PK-PD-studie af Generation 2-andexanet versus Generation 1), studie 16-508 (PK-PD-studie af andexanet hos personer af japansk etnicitet) og studie 14-505 (ANNEXA-4).
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate.
Danish: For at reducere denne risiko bør genoptagelse af antikoagulant behandling overvejes, så snart det er medicinsk passende.
English: Clinical efficacy is based upon reversal of anti-FXa-activity in healthy volunteers dosed with apixaban or rivaroxaban.
Danish: Klinisk virkning er baseret på revertering af anti-FXa-aktivitet hos raske frivillige, der blev doseret med apixaban eller rivaroxaban.
English: Submission of the final CSR by 30
Danish: Indsendelse af den endelige CSR:
English: List of possible side effects
Danish: Liste over mulige bivirkninger
English: While it is permissible to combine the bolus and infusion into a single IV bag, it is recommended that the bolus and infusion be split into two separate bags to ensure the correct administration rate.
Danish: Selvom det er tilladeligt at kombinere bolussen og infusionen i en enkelt i.v.-pose, anbefales det, at bolussen og infusionen fordeles i to separate poser for at sikre den korrekte administrationshastighed.
English: Administration using an intravenous bag 1.
Danish: Administration ved anvendelse af en intravenøs pose 1.
English: If needed, the reconstituted solution once transferred into the IV bag can be stored for an additional eight hours at room temperature.
Danish: Om nødvendigt kan den rekonstituerede opløsning, når den er overført til i.v.posen, opbevares i yderligere 8 timer ved stuetemperatur.
English: Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på hætteglasset og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Tell your doctor if you are taking, have recently taken, or might take, any other medicines.
Danish: Fortæl det altid til lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: • flushing or feeling hot
Danish: • rødmen eller varmefølelse
English: Use andexanet alfa within eight hours after reconstitution when stored at room temperature.
Danish: Anvend andexanet alfa inden for 8 timer efter rekonstitution, når det opbevares ved stuetemperatur.
English: For subjects on rivaroxaban, high-dose andexanet alfa (bolus plus infusion) resulted in increased thrombin generation above two standard deviations.
Danish: For forsøgspersoner på rivaroxaban resulterede højdosisandexanet alfa (bolus plus infusion) i en forøget trombingenerering, der var over to standardafvigelser.
English: The bolus and infusion are prepared in separate large volume syringes.
Danish: Bolussen og infusionen klargøres i separate sprøjter med stort volumen.
English: Due to the additional volume, the high dose bolus and infusion have to be further separated into additional syringes (two syringes apiece for bolus and infusion).
Danish: På grund af det ekstra volumen skal højdosis-bolussen og -infusionen fordeles yderligere i flere sprøjter (to sprøjter for hver af bolussen og infusionen).
English: In both, Study 14-503 and Study 14-504, treatment with andexanet alfa also resulted in a statistically significant increase in thrombin generation in healthy subjects anticoagulated with apixaban or rivaroxaban versus placebo (p < 0.0001).
Danish: I både studie 14-503 og studie 14-504 resulterede behandling med andexanet alfa også i en statistisk signifikant stigning i trombingenerering hos raske forsøgspersoner, der blev antikoaguleret med apixaban eller rivaroxaban versus placebo (p < 0,0001).
English: The effects of andexanet alfa can be measured through pharmacodynamic markers, including anti-FXa activity, and free fraction of available FXa inhibitor as well as through restoration of thrombin generation.
Danish: Virkningen af andexanet alfa kan måles ved hjælp af farmakodynamiske markører, herunder anti-FXaaktivitet og fri fraktion af tilgængelig FXa-inhibitor, samt ved reetablering af trombingenerering.
English: Change in anti-FXa activity (ng/mL) in healthy subjects anticoagulated with apixaban (A) and rivaroxaban (B)
Danish: Ændring i anti-FXa-aktivitet (ng/ml) hos raske forsøgspersoner, der blev antikoaguleret med apixaban (A) og rivaroxaban (B)
English: In order to further confirm the posology of Ondexxya, the MAH should submit the results of a comparative PK study with Generation 1, process 3, and Generation 2 material (study 19-514).
Danish: Indehaveren af markedsføringstilladelsen skal til yderligere bekræftelse af doseringen af Ondexxya indsende resultaterne af et komparativt PK-studie med Generation 1 proces 3 og Generation 2-materiale (studie 19-514).
English: The 30-day mortality rates were 16.2% (37/229) in patients presenting with ICH, 12.8% (12/94) with GI bleeding, and 17.9% (5/28) with other types of bleeding.
Danish: 30 dages-dødelighedsraterne var 16,2 % (37/229) hos patienter med ICH, 12,8 % (12/94) med GI-blødning og 17,9 % (5/28) med andre typer af blødning.
English: The primary endpoint for both Study 14-503 (apixaban) and Study 14-504 (rivaroxaban) was the percent change in anti-FXa activity from baseline to post-infusion nadir.
Danish: Det primære endepunkt for både studie 14-503 (apixaban) og studie 14-504 (rivaroxaban) var den procentvise ændring i anti-FXa-aktivitet fra baseline til postinfusions-lavpunktet.
English: To prevent the inadvertent transfer of air, be careful to hold the syringe needle up, and do not set the syringe down between multiple withdrawals from vials.
Danish: Vær omhyggelig med at holde sprøjtekanylen opad for at forhindre utilsigtet overførsel af luft, og undlad at sætte sprøjten ned mellem flere udtrækninger fra hætteglas.
English: • Alcohol swabs.
Danish: • Spritservietter.
English: Change from baseline in free FXa inhibitor concentration at nadir The mean unbound concentrations of apixaban and rivaroxaban were < 3.5 ng/mL and 4 ng/mL, respectively, after bolus andexanet alfa administration and were maintained throughout the continuous infusion.
Danish: Ændring fra baseline i koncentrationen af fri FXa-inhibitor ved lavpunktet De gennemsnitlige ubundne koncentrationer af apixaban og rivaroxaban var henholdsvis < 3,5 ng/ml og 4 ng/ml efter bolus-administration af andexanet alfa, og de blev opretholdt gennem den kontinuerlige infusion.
English: • Calculated number of vials (see section 4.2).
Danish: • Beregnet antal hætteglas (se pkt.
English: In the healthy subject trials, elevations > 2 x ULN in D-dimer and prothrombin fragments F1+2 were frequently observed.
Danish: I studierne med raske forsøgspersoner blev der hyppigt observeret forhøjelser > 2 x ULN af D-dimer og protrombinfragmenter F1+2.
English: High dose
Danish: Høj dosis
English: 400 mg at a target rate of 30 mg/min
Danish: 400 mg ved en målhastighed på 30 mg/min
English: Dosage recommendations have been defined from the effects of andexanet alfa in healthy volunteers administered a direct FXa inhibitor and from the ability to reverse the levels of anti-FXa activity.
Danish: Doseringsanbefalingerne er blevet defineret ud fra virkningen af andexanet alfa hos raske frivillige, der fik administreret en direkte FXa-inhibitor, og ud fra evnen til at revertere niveauerne af anti-FXaaktivitet.
English: It is unknown if andexanet alfa is excreted in human milk.
Danish: Det er ukendt, om andexanet alfa udskilles i human mælk.
English: Table 3: Summary of dosing for reversal of rivaroxaban
Danish: Tabel 3: Oversigt over dosering til revertering af rivaroxaban
English: In the clinical trials in healthy subjects administered an FXa inhibitor and then receiving andexanet alfa, no serious or severe adverse reactions were reported.
Danish: I de kliniske studier med raske forsøgspersoner, der fik administreret en FXa-inhibitor og herefter fik andexanet alfa, blev der ikke rapporteret nogen alvorlige eller svære bivirkninger.
English: From a microbiological point of view, once opened, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal præparatet bruges straks efter åbning.
English: Andexanet alfa is not recommended during pregnancy or in women of childbearing potential not using contraception.
Danish: Andexanet alfa bør ikke anvendes under graviditet eller til kvinder i den fertile alder, som ikke anvender sikker kontraception.
English: Pack size of four vials.
Danish: Pakningsstørrelse med 4 hætteglas.
English: Andexanet alfa reverses the anticoagulant effect of direct factor Xa (FXa) inhibitor products (apixaban, rivaroxaban) only.
Danish: Andexanet alfa reverterer udelukkende den antikoagulative virkning af direkte faktor Xa (FXa)inhibitorprodukter (apixaban, rivaroxaban).
English: Andexanet alfa is a specific reversal agent for FXa inhibitors.
Danish: Andexanet alfa er et specifikt reverteringsmiddel for FXa-inhibitorer.
English: The European Medicines Agency will review new information on this medicinal product at least every year, and this SmPC will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om lægemidlet, og produktresuméet vil om nødvendigt blive ajourført.
English: Total number of 200 mg vials needed
Danish: Nødvendigt samlet antal 200 mghætteglas
English: In healthy volunteers, dose-dependent increases in coagulation markers F1+2, TAT, and D-dimer after administration of andexanet alfa were observed, but no thromboembolic events were reported.
Danish: Hos raske frivillige er der observeret dosisafhængige stigninger i koagulationsmarkørerne F1+2, TAT og D-dimer efter administration af andexanet alfa, men der er ingen rapporterede tromboemboliske hændelser.
English: Reversing FXa inhibitor therapy exposes patients to the thrombotic risk of their underlying disease.
Danish: Revertering af FXa-inhibitorterapi eksponerer patienterne for den trombotiske risiko ved deres tilgrundliggende sygdom.
English: In the ANNEXA-4 study, 36 (10.3%) patients experienced a total of 42 thromboembolic events: cerebrovascular accident (CVA) (15/42; 35.7%), deep venous thrombosis (13/42; 33.1%), acute myocardial infarction (8/42; 19.0%), pulmonary embolism (5/42; 11.9%), and transient ischaemic attack (1/42; 2.4%).
Danish: I ANNEXA-4-studiet oplevede 36 (10,3 %) patienter i alt 42 tromboemboliske hændelser: cerebrovaskulært attak (CVA) (15/42, 35,7 %), dyb venetrombose (13/42, 33,1 %), akut myokardieinfarkt (8/42, 19,0 %), lungeemboli (5/42, 11,9 %) og transitorisk iskæmisk attak (1/42, 2,4 %).
English: Hyperhidrosis common
Danish: Hyperhidrose almindelig
English: The efficacy and safety of andexanet alfa have been evaluated in the following: 1) randomized, placebo-controlled, Phase II dose-ranging trials with healthy volunteers administered FXa inhibitors to establish doses required for reversal; 2) two Phase III studies, one with apixaban and the other with rivaroxaban, to confirm the efficacy of the high and low dose regimens; and 3) a global, multicentre, prospectively defined, open-label Phase IIIb/IV study (ANNEXA-4) in patients with an acute major bleeding episode requiring urgent reversal of FXa anticoagulation.
Danish: Sikkerheden og virkningen af andexanet alfa er blevet evalueret i følgende: 1) randomiserede, placebokontrollerede, dosisbestemmende fase II-studier med raske frivillige, der fik administreret FXa-inhibitorer, til fastlæggelse af hvilke doser, der er nødvendige til revertering, 2) to fase III-studier, det ene med apixaban og det andet med rivaroxaban, til bekræftelse af virkningen af høj- og lavdosisprogrammerne, og 3) et globalt, prospektivt defineret, åbent fase IIIb/IV-multicenterstudie (ANNEXA-4) med patienter med en akut større blødningsepisode, der krævede akut revertering af FXa-antikoagulation.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with andexanet alfa in one or more subsets of the paediatric population in treatment and prevention of FXa inhibitor-associated haemorrhages (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med andexanet alfa i en eller flere undergrupper af den pædiatriske population ved behandling og forebyggelse af FXa-inhibitor-forbundne blødninger (se pkt.
English: Use within eight hours after reconstitution when stored at room temperature.
Danish: Anvendes inden for 8 timer efter rekonstitution, når det opbevares ved stuetemperatur.
English: Administration using a syringe pump
Danish: Administration ved anvendelse af en sprøjtepumpe
English: After reconstitution, each mL of solution contains 10 mg of andexanet alfa.
Danish: Efter rekonstitution indeholder hver ml opløsning 10 mg andexanet alfa.
English: • Intravenous PO or PVC bag (150 mL or larger) to contain the final volume of reconstituted product (if administration is performed with an IV bag).
Danish: • Intravenøs PO- eller PVC-pose (150 ml eller større) til at indeholde det endelige volumen af rekonstitueret præparat (hvis administrationen udføres med en i.v.-pose).
English: 800 mg at a target rate of 30 mg/min
Danish: 800 mg ved en målhastighed på 30 mg/min
English: Based on data from 352 patients from the Phase IIIb/IV ANNEXA-4 study treated with an FXa inhibitor and experiencing an acute major bleeding episode, one patient experienced a serious or severe infusion-related reaction.
Danish: Baseret på data fra 352 patienter fra fase IIIb/IV ANNEXA-4-studiet, der blev behandlet med en FXainhibitor og havde en akut større blødningsepisode, opleverede én patient en alvorlig eller svær infusionsrelateret reaktion.
English: To reduce this risk, resumption of anticoagulant therapy should be considered as soon as medically appropriate after completion of treatment.
Danish: For at reducere denne risiko bør genoptagelse af antikoagulationsterapi overvejes, så snart det er medicinsk passende efter gennemført behandling.
English: Dysgeusia common
Danish: Dysgeusi almindelig
English: If a syringe driver is used for administration, multiple syringes should be used to contain the final volume of reconstituted product.
Danish: Hvis der anvendes en sprøjtepumpe til administration, skal der anvendes flere sprøjter til at indeholde det endelige volumen af rekonstitueret præparat.
English: Breast-feeding should be discontinued during treatment with andexanet alfa.
Danish: Amning skal ophøre under behandling med andexanet alfa.
English: Based on the available PK data, andexanet alfa has little to no renal clearance, and thus would not require dose adjustment for patients with renal impairment.
Danish: Baseret på de foreliggende farmakokinetikdata har andexanet alfa kun en lille eller ingen renal clearance, og en dosisjustering for patienter med nedsat nyrefunktion vil derfor ikke være nødvendig.
English: In the ANNEXA-4 study, of the patients in the safety population completing 30-day follow up (N=351), 54 patients (15.4%) died.
Danish: I ANNEXA-4-studiet var 54 patienter (15,4 %) døde ud af de patienter i sikkerhedspopulationen, der fik gennemført 30 dages-opfølgningen (N = 351).
English: Excipients: Tris base, Tris hydrochloride, L-arginine hydrochloride, sucrose, mannitol, polysorbate 80
Danish: Hjælpestoffer: Tris-base, Tris-hydrochlorid, L-argininhydrochlorid, saccharose, mannitol, polysorbat 80
English: If administration is done with a syringe driver, multiple syringes should be used to contain the final volume of reconstituted product.
Danish: Hvis administrationen udføres med en sprøjtepumpe, skal der anvendes flere sprøjter til at indeholde det endelige volumen af rekonstitueret præparat.
English: Once reconstituted, Ondexxya is for immediate use.
Danish: Når Ondexxya er rekonstitueret, skal det bruges straks.
English: Table 4 provides the list of adverse reactions from clinical studies of healthy subjects treated with andexanet alfa.
Danish: Tabel 4 viser en liste over bivirkninger fra kliniske studier med raske forsøgspersoner, der blev behandlet med andexanet alfa.
English: The 30-day mortality rates were 20.1% (44/219) in patients aged > 75 years old and 7.6% (10/132) in patients aged ≤ 75 years.
Danish: 30 dages-dødelighedsraterne var 20,1 % (44/219) hos patienter i alderen > 75 år og 7,6 % (10/132) hos patienter i alderen ≤ 75 år.
English: • The active substance is andexanet alfa.
Danish: - Aktivt stof: andexanet alfa.
English: Timing of FXa inhibitor last dose before andexanet alfa initiation
Danish: Tidsrummet fra sidste dosis FXa-inhibitor før start på andexanet alfa
English: Anti-FXa activity correlates poorly to clinical efficacy and safety, making it unsuitable for dosing guidance (see section 4.4 and 5.1)
Danish: Anti-FXa-aktiviteten korrelerer dårligt med klinisk virkning og sikkerhed, hvilket gør, at den er uegnet som vejledende ved dosering (se pkt.
English: FXa inhibitor last dose
Danish: FXa-inhibitor Sidste dosis
English: Contents of the pack and other information What Ondexxya contains
Danish: Pakningsstørrelser og yderligere oplysninger Ondexxya indeholder:
English: • if you are allergic to hamster proteins
Danish: - his du er allergisk over for hamsterproteiner.
English: Hepatic impairment: Based on the existing data on clearance of andexanet alfa, no dose adjustment is recommended.
Danish: Nedsat leverfunktion: På baggrund af eksisterende data vedrørende clearance af andexanet alfa anbefales ingen dosisjustering.
English: Median change from baseline to nadir in anti-FXa activity was -93.4% (95% CI -94.3%, -92.4%) for apixaban, and -92.5% (95% CI -94.2%, -90.3%) for rivaroxaban.
Danish: Median ændring fra baseline til lavpunktet i antiFXa-aktivitet var -93,4 % (95 % CI -94,3 %; -92,4 %) for apixaban og -92,5 % (95 % CI -94,2 %;90,3 %) for rivaroxaban.
English: Transfer the reconstituted solution from the syringe into an appropriate IV bag.
Danish: Overfør den rekonstituerede opløsning fra sprøjten til en passende i.v.-pose.
English: • IV PO or PVC bag (150 mL or larger) to contain the final volume of reconstituted product (if administration is done with an IV bag).
Danish: • I.v.-PO- eller PVC-pose (150 ml eller større) til at indeholde det endelige volumen af rekonstitueret præparat (hvis administrationen udføres med en i.v.-pose).
English: No interaction studies with andexanet alfa have been performed.
Danish: Der er ikke udført interaktionsstudier med andexanet alfa.
English: The occurrence of thromboembolic events was generally comparable between patients > 75 years (11.0%; 24/219) and those ≤ 75 years of age (9.1%; 12/132).
Danish: Forekomsten af tromboemboliske hændelser var generelt sammenlignelig mellem patienter i alderen > 75 år (11,0 %, 24/219) og patienter ≤ 75 år (9,1 %, 12/132).
English: Push the plunger down to slowly inject the 20 mL of water for injections into the vial, directing the stream toward the inside wall of the vial to minimise foaming.
Danish: Tryk stemplet ned til langsom injektion af de 20 ml vand til injektionsvæsker i hætteglasset, idet strålen rettes mod indersidevæggen af hætteglasset for at minimere skumdannelse.
English: The safety has been evaluated in clinical trials including 247 healthy subjects administered an FXa inhibitor, as well as in 352 patients in a Phase IIIb/IV trial (ANNEXA-4), who had acute major bleeding and were under treatment with an FXa inhibitor (mostly apixaban and rivaroxaban).
Danish: Sikkerheden er blevet evalueret i kliniske studier, der indbefattede 247 raske forsøgspersoner, der fik administreret en FXa-inhibitor, samt hos 352 patienter i et fase IIIb/IV-studie (ANNEXA-4), som havde akutte større blødninger og var i behandling med en FXa-inhibitor (overvejende apixaban og rivaroxaban).
English: Tris hydrochloride L-arginine hydrochloride Sucrose
Danish: Tris-hydrochlorid L-argininhydrochlorid Saccharose Mannitol
English: From a microbiological point of view, once reconstituted, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt bør præparatet bruges straks, når det er rekonstitueret.
English: Powder for solution for infusion 4 x 1 vial of 200 mg
Danish: Pulver til infusionsvæske, opløsning 4 x 1 hætteglas à 200 mg
English: This medicine has been designed to reverse the effects of factor Xa inhibitor medicines only.
Danish: Dette lægemiddel er blevet fremstillet til udelukkende at modvirke virkningen af faktor Xa-hæmmere.
English: Discard all used syringes, needles, and vials, including any unused portion of reconstituted solution.
Danish: Bortskaf alle brugte sprøjter, kanyler og hætteglas, herunder en eventuel ikke anvendt del af den rekonstituerede opløsning.
English: Feeling hot very common
Danish: Varmefølelse meget almindelig