FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic impairment - No dosing adjustment is necessary.
Danish: Nedsat leverfunktion - Dosisjustering er ikke nødvendig.
English: The effects on the incidence of MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.
Danish: Effekten af fondaparinux og enoxaparin på MI- og RI-incidensen var ikke statistisk forskellig.
English: In a randomised, double-blind, clinical trial in patients with a confirmed diagnosis of acute symptomatic DVT, fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50 kg, ≤ 100 kg) or 10 mg (body weight >100 kg) SC once daily was compared to enoxaparin sodium 1 mg/kg SC twice daily.
Danish: I et randomiseret dobbeltblindt klinisk studie med patienter med den bekræftede diagnose akut symptomatisk DVT blev fondaparinux 5 mg (legemsvægt < 50 kg), 7,5 mg (legemsvægt ≥ 50 kg, ≤ 100 kg) eller 10 mg (legemsvægt > 100 kg) administreret subkutant en gang daglig sammenlignet med enoxaparinnatrium 1 mg/kg subkutant to gange daglig.
English: In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥75 years, and/or with body weight <50 kg and/or with renal impairment with creatinine clearance ranging between 20 to 50 ml/min.
Danish: Hos patienter, der gennemgår en større ortopædisk operation, skal tidspunktet for første injektion af fondaparinux overholdes nøje hos de af patienterne, der er ≥75 år og/eller har en legemsvægt <50 kg og/eller med nedsat nyrefunktion med kreatininclearance i intervallet 20-50 ml/min.
English: Immune system disorders Rare: allergic reaction Metabolism and nutrition disorders
Danish: Sjælden: allergiske reaktioner Metabolisme og ernæring Sjælden: hypokaliæmi Nervesystemet
English: If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient's potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
Danish: Hvis en patient skal have foretaget perkutan koronarintervention (PCI), skal ufraktioneret heparin (UFH) administreres under PCI i henhold til lokale retningslinier under hensyntagen til patientens potentielle risiko for blødninger, inklusive tiden fra den sidste fondaparinuxdosis (se pkt.
English: At Day 9 the incidence of major bleeding on fondaparinux and enoxaparin was 2.1% and 4.1%, respectively (hazard ratio 0.52, 95% CI, 0.44;0.61, p < 0.001).
Danish: På dag 9 var incidensen af svær blødning for fondaparinux og enoxaparin hhv. 2,1 % og 4.1 % (hazard rate 0,52; 95 % CI 0,44-0,61; p < 0,001).
English: • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums)
Danish: • blødninger (f.eks. fra operationsstedet, fra allerede eksisterende mavesår, næseblod, tandkød)
English: If a patient is to undergo non-primary PCI, unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient's potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
Danish: Hvis en patient skal have foretaget en ikke-primær PCI, skal der administreres ufraktioneret heparin (UFH) i henhold til lokale retningslinier under hensyntagen til patientens potentielle risiko for blødninger, inklusive tiden fra den sidste fondaparinuxdosis (se pkt.
English: The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection.
Danish: Den anbefalede dosis fondaparinux er 2,5 mg én gang daglig, der indgives som subkutan injektion.
English: The safety of fondaparinux 2.5 mg has been evaluated in 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days, in 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week, 1407 patients undergoing abdominal surgery treated up to 9 days, and in 425 medical patients who are at risk for thromboembolic complications treated up to 14 days.
Danish: Sikkerheden ved administration af fondaparinux 2,5 mg er evalueret efter op til 9 dages behandling hos 3.595 patienter, der fik foretaget en større ortopædisk operation i underekstremiteterne, hos 327 patienter, der blev opereret for hoftefraktur og blev behandlet i 4 uger efter indgrebet., hos 1407 patienter, der blev behandlet i op til 9 dage i forbindelse med abdominal kirurgi, samt hos 425 medicinske patienter med risiko for tromboemboliske komplikationer, der blev behandlet i op til 14 dage.
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 én gang daglig, som indgives postoperativt som subkutan injektion.
English: No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
Danish: Dosisjustering er ikke påkrævet for patienter med mildt nedsat nyrefunktion (kreatininclearance > 50 ml/min.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/005-008
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/02/207/005-008
English: Glaxo Wellcome Production 1, rue de l'Abbaye F-76960 Notre Dame de Bondeville France
Danish: Glaxo Wellcome Production 1, rue de l'Abbaye 76960 Notre Dame de Bondeville Frankrig
English: In the predefined stratum comparing fondaparinux to UFH (patients treated with primary PCI (58.5%), fibrin-specific lytics (13%), non-fibrin-specific lytics (2.6%) and no reperfusion (25.9%)), the effects of fondaparinux and UFH on the incidence of death/re-MI at Day 30 were not statistically different: respectively, 8.3% vs 8.7% (hazard ratio 0.94, 95% CI, 0.79, 1.11 p = 0.460).
Danish: I det prædefinerede stratum, som sammenlignede fondaparinux med UFH (patienter behandlet med primær PCI (58,5 %), fibrinselektivt fibrinolytika (13 %), ikke-fibrinselektivt fibrinolytika (2,6 %) og ingen reperfusion (25,9 %)), var effekten af fondaparinux og UFH på incidensen af død/re-MI på dag 30 ikke statistisk forskellig; hhv. 8,3 % versus 8,7 % (hazard rate 0,94; 95 % CI 0,79-1,11; p = 0,460).
English: Inject ALL of the contents of the syringe by pressing down on the plunger as far as it goes.
Danish: Tøm sprøjten HELT ved at trykke stemplet helt i bund.
English: Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.
Danish: Nedsat leverfunktion - Farmakokinetikken af fondaparinux er ikke evalueret hos patienter med nedsat leverfunktion.
English: Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Danish: Perorale antikoagulantia (warfarin), trombocytfunktionshæmmende midler (acetylsalicylsyre), NSAIDs (piroxicam) og digoxin har ingen interaktion med fondaparinux farmakokinetik.
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: In those patients who underwent non-primary PCI <6 hours after the last dose of fondaparinux, the median dose of UFH was 5000 IU and the incidence of major bleeding was 4.1%
Danish: Hos patienter, som fik foretaget en ikke-primær PCI mindre end 6 timer efter sidste fondaparinuxdosis, var den mediane dosis UFH-dosis 5000 IE, og incidensen af svær blødning var 4,1 % (2/49).
English: Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Danish: Der blev observeret større blødninger hos 3,4 % af patienterne i fondaparinuxgruppen over for 2,4 % i dalteparingruppen.
English: Manufacturer: Glaxo Wellcome Production, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Danish: Fremstiller: Glaxo Wellcome Production, 1, rue de l'Abbaye, F-76960 Notre Dame de Bondeville, Frankrig
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 én gang daglig som subkutan injektion.
English: Picture B
Danish: Figur B
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 (see section 5.1).
Danish: Forebyggelse af venøse tromboemboliske komplikationer (VTE) hos patienter, som gennemgår abdominalkirurgi, med høj risiko for tromboemboliske komplikationer, fx ved abdominalcancer (se pkt.5.1).
English: • if you notice any particles in the solution, or if the solution is discoloured
Danish: • hvis du bemærker, at opløsningen indeholder partikler eller er misfarvet
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 i forbindelse med anden samtidig trombocytfunktionshæmmende behandling (aspirin, thienopyridin).
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: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children.
Danish: ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN Opbevares utilgængeligt for børn.
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 for patienter med en kreatininclearance på 20 - 50 ml/min.
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 rate 0,87; 95 % CI 0,77-0,98; p = 0,02).
English: Picture G
Danish: Figur G
English: It is supplied in a pre-filled, single-use syringe fitted with an automatic safety system to help prevent needle stick injuries after use.
Danish: Det leveres i en fyldt engangssprøjte forsynet med et automatisk sikkerhedssystem til forebyggelse af nålestik efter brug.
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 en kreatininclearance < 50ml/min har øget risiko for blødning og VTE, hvorfor der skal udvises forsigtighed ved behandling (se pkt.
English: The Quixidar pre-filled syringe has been designed with an automatic needle protection system to prevent needle stick injuries following injection.
Danish: De fyldte Quixidar injektionssprøjter er forsynet med et system til beskyttelse af kanylen, som beskytter mod skader pga. nålestik efter injektionen.
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 endpoint blandt 5,8 % af patienterne sammenlignet med 5,7 % blandt de patienter der blev behandlet med enoxaparin (hazard rate 1,01; 95 % CI 0,90-1,13; ensidet- noninferioritets-p-værdi = 0,003).
English: Fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50kg, ≤ 100 kg) or 10 mg (body weight >100 kg) SC once daily was compared to unfractionated heparin IV bolus (5000 IU) followed by a continuous IV infusion adjusted to maintain 1.5-2.5 times aPTT control value.. A total of 2184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22 days (mean 7 days).
Danish: Fondaparinux 5 mg (legemsvægt < 50 kg), 7,5 mg (legemsvægt ≥ 50kg, ≤ 100 kg) eller 10 mg (legemsvægt > 100 kg) administreret subkutant en gang daglig blev sammenlignet med ufraktioneret heparin som intravenøs bolusinjektion (5000 IE) efterfulgt af en kontinuerlig intravenøs infusion justeret, så der opretholdtes en kontrolværdi på 1,5-2,5 gange aPTT.
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 fatale, hos 8 patienter (2,4 %) i behandling med 2,5mg fondaparinux, mens det blev set hos 2 patienter (0,6 %) i placebogruppen.
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: However, the use of fondaparinux should be considered with caution because of an increased risk of bleeding due to a deficiency of coagulation factors in patients with severe hepatic impairment (see section 4.2).
Danish: Man skal dog overveje brugen af fondaparinux nøje på grund af den øgede blødningstendens, som skyldes reducerede koagulationsfaktorer hos patienter med alvorligt nedsat leverfunktion (se pkt.
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: • reduction in potassium in your blood
Danish: • nedsat indhold af kalium i blodet
English: • The other ingredients are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH.
Danish: • De øvrige indholdsstoffer er natriumchlorid, vand til injektionsvæsker og saltsyre og/eller natriumhydroxid til pH-justering.
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 alvorligt nedsat nyrefunktion (kreatininclearance <30 ml/min) (se pkt.
English: Quixidar
Danish: Hæmoragi
English: In patients treated with primary PCI, the incidence of death/re-MI at Day 30 was not statistically different between the two groups [6.0% in fondaparinux group vs 4.8% in the control group; hazard ratio 1.26, 95% CI, 0.96, 1.66)].
Danish: For patienter, som var blevet behandlet med primær PCI, var der ikke signifikant forskel i incidensen af død/re-MI efter 30 dage mellem de to grupper (hhv. 6,0 % i fondaparineuxgruppen versus 4,8 % i kontrolgruppen (hazard rate 1,26; 95 % CI 0,96-1,66)).
English: How long should Quixidar be taken for
Danish: Hvor længe skal du bruge Quixidar
English: → Tell your doctor if you think any of these applies to you.
Danish: • hvis du har en meget alvorlig nyresygdom → Fortæl det til lægen, hvis du mener, at noget af dette passer på dig.
English: HOW TO STORE QUIXIDAR
Danish: SÅDAN OPBEVARER DU QUIXIDAR
English: Gently pinch the skin that has been cleaned to make a fold.
Danish: Efter rensning dannes en fold i huden ved at nive let.
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 %), fibrinselektivt 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 rate 0,80; 95 % CI 0,69-0,93; p =
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 dyb venetrombose eller lungeemboli, var henholdsvis 3,0 %, 4,5 % og 6,5 %.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du vil have yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant:
English: • if you have severe liver disease
Danish: • hvis du lider af en alvorlig leversygdom
English: • prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery
Danish: Quixidar anvendes til: at forebygge dannelsen af blodpropper i blodkar i benene eller lungerne efter en ortopædisk operation (f.eks. i hofte eller knæ), eller efter en operation i maven.
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, over for 1,2 % af dem, der fik enoxaparin.
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 rate 0,79; 95 % CI 0,68-0,93; p= 0,003).
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 rate 0,83; 95 % CI 0,71-0,97; p = 0,02).
English: Body weight 50-100 kg
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Legemsvægt 50-100 kg.
English: Quixidar is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Danish: Quixidar er et lægemiddel, som hjælper med at forhindre, at der dannes blodpropper i blodkarrene (et antitrombotisk middel).
English: • increase in the amount of non-protein nitrogen in the blood
Danish: • øget nitrogenindhold i blodet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ELLER, NÅR EN SÅDAN IKKE FINDES, PÅ DEN INDRE EMBALLAGE
English: EXPIRY DATE EXP {month/year}
Danish: UDLØBSDATO UDLØBSDATO {MM/ÅÅÅÅ}
English: • diarrhoea or constipation
Danish: • diaré eller forstoppelse
English: For step-by-step instructions please see over the page
Danish: Ensure consistent writing of placebogruppen; please check throughout the document.
English: The safety of fondaparinux 2.5 mg has been evaluated in: - 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days - 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week - 1407 patients undergoing abdominal surgery treated up to 9 days - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days - 10,057 patients undergoing treatment of UA or NSTEMI ACS - 6,036 patients undergoing treatment of STEMI ACS.
Danish: Sikkerheden ved administration af fondaparinux 2,5 mg er evalueret i: - 3.595 patienter, der fik foretaget en større ortopædisk operation i underekstremiteterne og blev behandlet i op til 9 dage - 327 patienter, der blev opereret for hoftefraktur og blev behandlet i 3 uger efter indgrebet, efter en indledende forebyggelsesperiode på 1 uge - 1407 patienter, der blev behandlet i op til 9 dage i forbindelse med abdominal kirurgi, samt hos 425 medicinske patienter med risiko for tromboemboliske komplikationer, der blev behandlet i op til 14 dage.
English: You should check with your doctor or pharmacist if you are not sure.
Danish: • Kontakt din læge eller apotek, hvis der er noget, som du er i tvivl om.
English: Prevention of Venous Thromboembolic Events (VTE) in patients 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) i forbindelse med større ortopædkirurgiske indgreb i underekstremiteterne som fx ved hoftefraktur og knæ- eller hofteledsalloplastik.
English: • Treatment of UA/NSTEMI and STEMI - fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
Danish: • Behandling af UA/NSTEMI og STEMI - Fondaparinux må ikke anvendes til patienter med kreatininclearance < 20 ml/min.
English: • if you have kidney disease
Danish: • hvis du lider af en nyresygdom
English: Uncommon: pain, oedema, Rare: reaction at injection site
Danish: Sjælden: erythematøst hududslæt, lokal reaktion ved injektionssted
English: • The active substance is 2.5 mg fondaparinux sodium in 0.5 ml solution for injection
Danish: • Det aktive stof er 2,5 mg fondaparinuxnatrium i 0,5 ml injektionsvæske
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 statelasmakoncentrationer, hvilket er forbundet med højere alder: Cmax (mg/l) - 0,50 (32 %), Cmin (mg/l)
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 en kreatininclearance under 50ml/min har øget risiko for blødning og VTE, hvorfor der skal udvises forsigtighed ved behandling (se pkt.
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: MARKETING AUTHORISATION NUMBERS EU/1/02/207/009-011, 018
Danish: EU/1/02/207/009-011, 018
English: GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900
Danish: GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com
English: What Quixidar looks like and contents of the pack Quixidar is a clear and colourless to slightly yellow solution for injection.
Danish: Quixidar er en klar og farveløs eller svag gul injektionsvæske.