FrancophonIA/ELRC3.0 huggingface dataset:
English: At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, affect routine coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
Danish: I de doser, der anvendes til behandling, påvirker fondaparinux ikke i klinisk relevant omfang rutine koagulationstest som aktiveret partiel tromboplastintid (aPTT), aktiveret koagulationstid (ACT) eller protrombintid (PT)/International Normalised Ratio (INR) eller fibrinolytisk aktivitet eller kapillærblødningstiden.
English: An updated RMP should be submitted: • At the request of the European Medicines Agency;
Danish: En opdateret RMP skal fremsendes:
English: Patients with Heparin Induced Thrombocytopenia
Danish: Patienter med heparin-induceret trombocytopeni
English: Renal impairment - Compared with patients with normal renal function (creatinine clearance > 80 ml/min), plasma clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 80 ml/min) and on average 2 times lower in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
Danish: Nedsat nyrefunktion - Sammenlignet med patienter med normal nyrefunktion (kreatininclearance >80 ml/min) er plasmaclearance 1,2 til 1,4 gange lavere hos patienter med let nedsat nyrefunktion (kreatininclearance 50-80 ml/min) og gennemsnitligt 2 gange lavere hos patienter med moderat nedsat nyrefunktion (kreatininclearance 30-50 ml/min).
English: Patients could be recommended to self-inject the product when they are judged willing and able to do so. Physicians should provide clear instructions for self-injection.
Danish: Hvis patienten ønsker det og er i stand til det, kan patienten anbefales selv at injicere præparatet.
English: Patients undergoing major orthopaedic or abdominal surgery The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection.
Danish: Patienter, der gennemgår større ortopædisk eller abdominal operation Den anbefalede dosis fondaparinux er 2,5 mg en gang daglig, som indgives postoperativt som subkutan injektion.
English: Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 patients (1.4%) vs 77 patients (35%), respectively].
Danish: Fondaparinux medførte en signifikant reduktion af den generelle forekomst af venøse tromboemboliske komplikationer sammenlignet med placebo [henholdsvis 3 patienter (1,4 %) versus 77 patienter (35 %)].
English: After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.2).
Danish: Efter indledning med en startdosis på 10 mg om dagen bør det overvejes at reducere døgndosis til 7,5 mg ud fra farmakokinetisk modellering (se pkt.
English: The syringe needle shield contains latex.
Danish: Kanylehylsteret indeholder latex.
English: Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Danish: Trombocytfunktionshæmmere (acetylsalicylsyre), NSAIDs (piroxicam) og digoxin udviste ingen interaktion med fondaparinux farmakokinetik.
English: • if you have severe kidney disease.
Danish: • hvis du har en alvorlig nyresygdom.
English: In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and spinal/epidural anaesthesia or spinal puncture.
Danish: Ved større ortopædiske operationer er det ikke muligt ved samtidig brug af fondaparinux og spinal/epiduralanæstesi eller spinalpunktur at udelukke forekomsten af epidurale eller spinale hæmatomer, som kan føre til langvarig eller permanent paralyse.
English: In patients ≥75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4).
Danish: Fondaparinux bør gives med forsigtighed til patienter ≥75 år, da nyrefunktionen aftager med alderen (se pkt.
English: The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once daily administered by subcutaneous injection.
Danish: Den anbefalede dosis af fondaparinux (til patienter med legemsvægt ≥50 kg, ≤100 kg) er 7,5 mg en gang daglig som subkutan injektion.
English: In this subgroup, after an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.4).
Danish: Efter indledning med en dosis på 10 mg om dagen bør det hos denne undergruppe overvejes at reducere døgndosis til 7,5 mg ud fra farmakokinetisk modellering (se pkt.
English: 4.9 Overdose Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding.
Danish: Fondaparinux i doser ud over det anbefalede niveau kan øge blødningstendensen.
English: The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to demonstrate the efficacy of fondaparinux for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Danish: Fondaparinux kliniske forsøgsprogram til forebyggelse af venøse tromboemboliske komplikationer (VTE) var tilrettelagt med henblik på at påvise virkningen af fondaparinux til behandling af DVT og PE.
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester og injektionssprøjter.
English: Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Danish: Præparater, der kan øge blødningsrisikoen, bør ikke anvendes sammen med fondaparinux.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity.
Danish: Der er ikke observeret nogen speciel fare for mennesker i prækliniske data baseret på traditionelle studier af sikkerhedsfarmakologi, toksikologi med gentagen indgift og gentoksikologi.
English: In UA/NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole anticoagulant during PCI is not recommended due to an increased risk of guiding catheter thrombus (see clinical studies section 5.1).
Danish: UA/NSTEMI- og STEMI-patienter, som skal have foretaget en ikke-primær PCI, bør ikke behandles med fondaparinux som eneste antikoagulans under PCI-proceduren,, da der er øget risiko for kateterrelateret trombose (se pkt.
English: The main sites of surgery were colonic/rectal, gastric, hepatic, cholecystectomy or other biliary.
Danish: De primære operationsområder var colon/rektum, ventrikel, lever og galdeblære.
English: Picture D
Danish: Figur D
English: • Prevention of VTE - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Danish: • Forebyggelse af VTE - Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: Of the patients in the fondaparinux group, 5.8% experienced an event by Day 9 compared to 5.7% for enoxaparin-treated patients (hazard ratio 1.01, 95% CI, 0.90, 1.13, one-sided non-inferiority p value = 0.003).
Danish: I fondaparinuxgruppen forekom det primære sammensatte endepunkt blandt 5,8 % af patienterne sammenlignet med 5,7 % blandt de patienter, der blev behandlet med enoxaparin (hazard ratio 1,01; 95 % CI, 0,90-1,13; ensidet-noninferioritets-p-værdi = 0,003).
English: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland Manufacturer:
Danish: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Irland
English: In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
Danish: For patienter som initielt ikke fik reperfusion, var incidensen for alvorlig blødning 1,2 % for fondaparinux versus 1,5 % i kontrolgruppen.
English: The efficacy findings and results on severe haemorrhage were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines).
Danish: Effektparametre og resultater af alvorlig blødning var konsistent mellem de præspecificerede undergrupper, så som ældre patienter med nedsat nyrefunktion og samtidig administration af trombocytaggregationshæmmere (aspirin, thienopyridin).
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa.
Danish: Fondaparinux antitrombotiske aktivitet skyldes antitrombin III (antitrombin)-medieret selektiv hæmning af Faktor Xa.
English: To avoid the loss of medicinal product when using the pre-filled syringe do not expel the air bubble from the syringe before the injection.
Danish: For at undgå tab af det aktive stof fra den fyldte injektionssprøjte skal luftboblen ikke presses ud før injektionen.
English: Syringe with an automatic needle protection system
Danish: Injektionssprøjte med automatisk beskyttelsessystem af nålen
English: Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
Danish: Under den indledende behandling sås større blødninger hos 1,3 % af de patienter, der fik fondaparinux sammenlignet med 1,1 % af dem, der fik ufraktioneret heparin.
English: • diarrhoea or constipation
Danish: • diarré eller forstoppelse
English: The efficacy findings and results on major bleeding were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines or GP IIb/IIIa inhibitors).
Danish: Effektparametrene og resultaterne vedrørende svær blødning var konsistent mellem de præspecificerede undergrupper, så som ældre patienter med nedsat nyrefunktion og ved samtidig administration af trombocytaggregationshæmmere (aspirin, thienopyridiner eller GP-IIb/IIIahæmmere).
English: In the predefined stratum comparing fondaparinux to placebo (i.e patients treated with nonfibrin specific lytics (77.3%), no reperfusion (22%), fibrin-specific lytics (0.3%), primary PCI (0.4%), the incidence of death/re-MI at Day 30 was significantly reduced from 14.0% on placebo to 11.3% (hazard ratio 0.80, 95% CI, 0.69, 0.93, p = 0.003).
Danish: I det prædefinerede stratum, som blev anvendt til at sammenligne fondaparinux med placebo (dvs. patienter, der blev behandlet med ikke-fibrinselektivt fibrinolytika (77,3), ingen reperfusion (22 %), fibrinselektive fibrinolytika (0,3 %), primær PCI (0,4 %)), var incidensen af død/re-MI efter 30 dage signifikant reduceret fra 14,0 % for placebo til 11,3 % (hazard ratio 0,80; 95 % CI, 0,69-0,93; p =
English: No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat nyrefunktion (kreatininclearance >50 ml/min).
English: In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the fondaparinux patients and in 2.0% of controls.
Danish: For patienter, som fik fibrinolyse, opstod der alvorlige blødninger blandt 1,3 % af fondaparinuxpatienter og 2,0 % af patienterne i kontrolgruppen.
English: Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, compared to 1.2% with enoxaparin.
Danish: Under den indledende behandling optrådte større blødninger hos 1,1 % af de patienter, der fik fondaparinux sammenlignet med 1,2 % af dem, der fik enoxaparin.
English: By binding selectively to ATIII, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by ATIII.
Danish: Ved selektiv binding til ATIII øger fondaparinux ATIII naturlige hæmning af Faktor Xa (ca. 300 gange).
English: • drowsiness or tiredness
Danish: • døsighed eller træthed
English: Arixtra syringe may contain latex
Danish: Arixtra injektionssprøjter kan indeholde latex
English: Syringe with a manual needle protection system showing security sleeve being pulled over needle AFTER USE
Danish: Injektionssprøjte med et manuelt sikkerhedssystem, hvor en sikkerhedsmanchet bliver trukket hen over nålen efter brug.
English: The incidence of all cause mortality at Day 30 was also significantly reduced from 8.9% for the control group to 7.8% in the fondaparinux group (hazard ratio 0.87, 95% CI, 0.77;0.98, p = 0.02).
Danish: Den samlede mortalitetsincidens efter 30 dage var ligeledes signifikant reduceret fra 8,9 % for kontrolgruppen til 7,8 % i fondaparinuxgruppen (hazard ratio 0,87; 95 % CI, 0,77-0,98; p = 0,02).
English: INFORMATION IN BRAILLE arixtra 10 mg
Danish: arixtra 10 mg
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1).
Danish: Forebyggelse af venøse tromboemboliske komplikationer (VTE) hos voksne, som gennemgår abdominalkirurgi, og som skønnes at have høj risiko for tromboemboliske komplikationer, fx patienter med abdominalcancer (se pkt.
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa.
Danish: Fondaparinux antitrombotiske aktivitet skyldes antitrombin III (ATIII)-medieret selektiv hæmning af Faktor Xa.
English: Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Danish: Forebyggelse af venøse tromboemboliske komplikationer (VTE) hos voksne i forbindelse med større ortopædkirurgiske indgreb i underekstremiteterne som fx ved hoftefraktur og knæ- eller hofteledsalloplastik.
English: Do not throw away any medicines or syringes via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Rare: allergic reaction (including very rare reports of angioedema, anaphylactoid/anaphylactic reaction)
Danish: meget sjældne tilfælde af angioødem, anafylaktoid/anafylaktisk reaktion)
English: Neutralisation of Factor Xa interrupts the blood coagulation cascade and inhibits both thrombin formation and thrombus development.
Danish: Hæmning af Faktor Xa standser koagulationsprocessen, hvorved trombinsyntese og trombedannelse reduceres.
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2.5 mg subcutaneously once daily versus enoxaparin 1 mg/kg subcutaneously twice daily in approximately 20,000 patients with UA/NSTEMI.
Danish: OASIS 5 var en dobbeltblindet, randomiseret, noninferioritetsundersøgelse af fondaparinux 2,5 mg subkutant en gang daglig versus enoxaparin 1 mg/kg subkutant to gange daglig til ca. 20.000 patienter med UA/NSTEMI.
English: Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively.
Danish: Incidensen for blødninger hos patienter i aldersgruppen <65 år, 65-75 år og >75 år, der fik den anbefalede behandling med fondaparinux for DVT eller PE, var henholdsvis 3,0 %, 4,5 % og 6,5 %.
English: Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (See section 4.3).
Danish: Fondaparinux bør ikke anvendes til patienter med svært nedsat nyrefunktion (kreatininclearance <30 ml/min) (se pkt.
English: Treatment of Deep Venous Thrombosis
Danish: Behandling af dyb venetrombose
English: • bruising or swelling (oedema)
Danish: • blå mærker eller hævelse (ødem)
English: In patients who were revascularised with a thrombolytic, fondaparinux significantly reduced the incidence of death/re-MI at Day 30 from 13.6% for the control group to 10.9% (hazard ratio 0.79, 95%CI, 0.68;0.93, p = 0.003).
Danish: Hos patienter, som blev revaskulariseret med fibrinolytika, reducerede fondaparinux incidensen af død/re-MI signifikant efter 30 dage fra 13,6 % for kontrolgruppen til 10,9 % (hazard ratio 0,79; 95 % CI, 0,68-0,93; p= 0,003).
English: Alternate the left and right side of the lower abdominal area at each injection.
Danish: Indsprøjtningerne foretages skiftevis i venstre og højre side nederst på maven.
English: Uncommon: nausea, vomiting
Danish: Ikke almindelig: kvalme, opkastning
English: For treatment of UA/NSTEMI and STEMI-Fondaparinux should be used with caution in patients who are being treated concomitantly with other agents that increase the risk of haemorrhage (such as GPIIb/IIIa inhibitors or thrombolytics).
Danish: • Til behandling af UA/NSTEMI og STEMI - Fondaparinux bør anvendes med forsigtighed til patienter, der er i samtidig behandling med andre præparater, der øger risikoen for blødninger (fx GP-IIb/IIIa-hæmmere eller fibrinolytika).
English: Where the instruction for a syringe is different this is clearly stated.
Danish: Det vil tydeligt fremgå af vejledningen, hvor instruktionen for de to injektionssprøjter er forskellige.
English: Prevention of VTE and Treatment of UA/NSTEMI and STEMI - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Danish: • Forebyggelse af VTE og behandling af UA/NSTEMI og STEMI - Dosisjustering er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: • Prophylaxis of VTE - Patients with creatinine clearance <50 ml/min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
Danish: • Forebyggelse af VTE - Patienter med kreatininclearance <50 ml/min har øget risiko for blødning og VTE, hvorfor der skal udvises forsigtighed ved behandling (se pkt.
English: Do not administer intramuscularly.
Danish: Anvend ikke intramuskulær injektion.
English: • after the expiry date shown on the label and carton
Danish: • efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: INFORMATION IN BRAILLE arixtra 7.5 mg
Danish: arixtra 7,5 mg
English: The mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients with VTE receiving the fondaparinux proposed dose regimen once daily are: Cmax (mg/l) - 1.41 (23 %), Tmax (h) - 2.4 (8%) and Cmin (mg/l) -0.52 (45 %).
Danish: Gennemsnitlige (CV %) farmakokinetiske parametre ved steady state for fondaparinux hos patienter med VTE, der fik det foreslåede behandlingsregime en gang daglig, vurderes til: Cmax (mg/l) -1,41 (23 %), Tmax (h) 2,4 (8 %) og Cmin (mg/l) -0,52 (45 %).
English: Arixtra syringe contains latex
Danish: Arixtra injektionssprøjter indeholder latex
English: What Arixtra looks like and contents of the pack Arixtra is a clear and colourless to slightly yellow solution for injection.
Danish: Arixtra er en klar og farveløs til svag gul injektionsvæske.
English: The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.4 and 5.2).
Danish: Dosis bør reduceres til 1,5 mg daglig hos patienter med kreatininclearance på 20-50 ml/min (se pkt.
English: Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Danish: Nedsat leverfunktion - Dosisjustering er ikke nødvendig for patienter med let eller moderat nedsat leverfunktion.
English: In hip fracture patients, associated with their increased age, fondaparinux steady state plasma concentrations are: Cmax (mg/l) - 0.50 (32%), Cmin (mg/l) - 0.19 (58%).
Danish: Hos patienter med hoftefrakturer ses følgende steady stateplasmakoncentrationer, hvilket er forbundet med højere alder: Cmax (mg/l) -0,50 (32 %), Cmin (mg/l)
English: • if you have severe liver disease
Danish: • hvis du har en alvorlig nyresygdom
English: This unlocks the sleeve.
Danish: Herved vil hætten blive løsnet.
English: Major bleedings, all at surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg compared to 2 (0.6%) with placebo.
Danish: Der blev observeret større blødninger ved operationsstedet, heraf ingen letale, hos 8 patienter (2,4 %) i behandling med 2,5 mg fondaparinux, mens det blev set hos 2 patienter (0,6 %) i behandling med placebo.
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery
Danish: Forebyggelse af tromboemboliske komplikationer (VTE) hos patienter, der gennemgår abdominalkirurgi, med høj risiko for tromboemboliske komplikatoner, fx ved abdominalcancer
English: By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by antithrombin.
Danish: Ved selektiv binding til antitrombin TIII øger fondaparinux antitrombin TIII naturlige hæmning af Faktor Xa (ca. 300 gange).
English: The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/min (see sections 4.2 and 5.2).
Danish: Dosis bør reduceres til 1,5 mg daglig hos patienter med kreatininclearance 20-50 ml/min (se pkt.
English: The adverse reactions reported by the investigator as at least possibly related to fondaparinux are presented within each frequency grouping (very common ≥ 1/10; common: ≥1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to <1/1,000; very rare <1/10,000) and system organ class by decreasing order of seriousness.
Danish: De bivirkninger, der er rapporteret af investigator, og som i hvert fald muligvis kan tilskrives fondaparinux, er anført efter hyppigheden af hændelsen (meget almindelig ≥1/10; almindelig ≥1/100<1/10; ikke almindelig ≥1/1.000 - <1/100; sjælden ≥1/10.000 - <1/1.000; meget sjælden <1/10.000) og inden for hver organklasse efter aftagende sværhedsgrad.
English: Syringe with a manual needle protection system
Danish: Injektionssprøjte med manuelt beskyttelsessystem af nålen
English: Fondaparinux should be used with caution in patients with a history of HIT.
Danish: Fondaparinux bør anvendes med forsigtighed til patienter med HIT i anamnesen.
English: By Day 30, the incidence of all cause mortality was significantly reduced from 3.5% on enoxaparin to 2.9% on fondaparinux (hazard ratio 0.83, 95% CI, 0.71;0.97, p = 0.02).
Danish: På dag 30 reducerede fondaparinux signifikant den samlede mortalitetsincidens fra 3,5 % for enoxaparin til 2,9 % (hazard ratio 0,83; 95 % CI, 0,71-0,97; p = 0,02).
English: Breast-feeding is not recommended during treatment with fondaparinux.
Danish: Amning frarådes under behandling med fondaparinux.
English: Patients with creatinine clearance <50 ml/min are at increased risk of bleeding and VTE and should be treated with caution (see sections 4.2, 4.3 and 5.2).
Danish: Patienter med kreatininclearance under 50 ml/min har øget risiko for blødning og VTE, hvorfor der skal udvises forsigtighed ved behandling (se pkt.
English: The pharmacokinetics of fondaparinux has not been studied in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Danish: Fondaparinux' farmakokinetik er ikke undersøgt hos patienter med svært nedsat leverfunktion (se pkt.
English: 1: Odds ratio: Low Dose/Standard Dose Note: MI - myocardial infarction.
Danish: 1: Odds ratio: Lavdosis/standarddosis
English: When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
Danish: Samtidig behandling med vitamin K-antagonister bør gives efter behov i henhold til oplysningerne i pkt.
English: The Arixtra pre-filled syringes have been designed with a needle protection system to prevent needle stick injuries following injection.
Danish: De fyldte Arixtra injektionssprøjter er forsynet med et system til beskyttelse af kanylen, som beskytter mod skader pga. nålestik efter injektionen.