FrancophonIA/ELRC3.0 huggingface dataset:
English: Insert the full length of the needle at right angles into the skin fold (picture E).
Danish: Indfør kanylen i hele dens længde vinkelret på hudfolden (fig. E).
English: The efficacy and safety of fondaparinux have not been formally studied in patients with HIT type II.
Danish: Sikkerhed og virkning af fondaparinux er ikke undersøgt formelt hos patienter med HIT II.
English: Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human milk.
Danish: Fondaparinux udskilles i modermælk hos rotter, men om fondaparinux udskilles i modermælk hos mennesket vides ikke.
English: • Quixidar does not need to be kept in the fridge.
Danish: • Quixidar behøves ikke at blive opbevaret i køleskab.
English: • anaemia (a reduction in the number of red blood cells).
Danish: • anæmi (nedsat antal røde blodlegemer).
English: A total of 2192 patients were treated; for both groups, patients were treated for at least 5 days and up to 26 days (mean 7 days).
Danish: I begge grupper blev patienterne behandlet i mindst 5 dage og højst 26 dage (7 dage i gennemsnit).
English: In severe renal impairment (creatinine clearance <30 ml/min), plasma clearance is approximately 5 times lower than in normal renal function.
Danish: Ved svært nedsat nyrefunktion (kreatininclearance <30 ml/min) er plasmaclearance ca. 5 gange lavere end ved normal nyrefunktion.
English: The incidence of adjudicated major bleeding was 2.1% (fondaparinux) vs. 4.1% (enoxaparin) up to and including Day 9 in the Phase III UA/NSTEMI study, and the incidence of adjudicated severe hemorrhage by modified TIMI criteria was 1.1% (fondaparinux) vs. 1.4% (control [UFH/placebo]) up to and including Day 9 in the Phase III STEMI study.
Danish: Incidensen af erklæret svær blødning var 2,1 % (fondaparinux) versus 4,1 % (enoxaparin) til og med dag 9 i fase-III undersøgelsen for UA/NSTEMI, og incidensen af erklæret svær blødning ifølge modificerede TIMI-kriterier var 1,1 % (fondaparinux) versus 1,4 % (kontrol [UFH/placebo]) til og med dag 9 i fase III-undersøgelsen for STEMI.
English: Solution for injection, 2 pre-filled syringes with an automatic safety system Solution for injection, 7 pre-filled syringes with an automatic safety system Solution for injection, 10 pre-filled syringes with an automatic safety system Solution for injection, 20 pre-filled syringes with an automatic safety system
Danish: Injektionsvæske, opløsning, 2 fyldte injektionssprøjter med automatisk sikkerhedssystem Injektionsvæske, opløsning, 7 fyldte injektionssprøjter med automatisk sikkerhedssystem Injektionsvæske, opløsning, 10 fyldte injektionssprøjter med automatisk sikkerhedssystem Injektionsvæske, opløsning, 20 fyldte injektionssprøjter med automatisk sikkerhedssystem
English: Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
Danish: Behandling af akut dyb venetrombose (DVT) og behandling af akut lungeemboli (PE), undtagen hos patienter med ustabil hæmodynamik eller patienter med behov for trombolyse eller lungeembolektomi.
English: 7.5 mg once a day
Danish: 7,5 mg daglig.
English: The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days of randomisation.
Danish: Det primære sammensatte endpoint var død og reinfarkt (re-MI) senest 30 dage efter randomisering.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISTION HOLDER
Danish: • BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous or intravenous use Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Subkutan eller intravenøs anvendelse Læs indlægssedlen før brug.
English: • if you have a risk of uncontrolled bleeding (haemorrhage) including: · stomach ulcer · bleeding disorders · recent bleeding into the brain (intracranial bleeding) · recent surgery on the brain, spine or eye
Danish: • hvis du har risiko for blodtab (ukontrollerede blødninger) på grund af: · mavesår · blødersygdomme · nylig hjerneblødning (intrakraniel blødning ) · nylig operation i hjerne, ryg eller øjne
English: In vitro, fondaparinux is highly and specifically bound to antithrombin protein with a dose-dependant plasma concentration binding (98.6% to 97.0% in the concentration range from 0.5 to 2 mg/l).
Danish: In vitro bindes fondaparinux med høj affinitet og specifikt til antitrombinprotein med en dosisafhængig plasmakoncentrationsbinding (98,697,0 % i koncentrationsintervallet fra 0,5 til 2 mg/l).
English: • This medicine has been prescribed for you personally.
Danish: • Lægen har ordineret Quixidar til dig personligt.
English: Syringe AFTER USE
Danish: Kanyle EFTER BRUG
English: Fondaparinux also provided a significant reduction in the rate of symptomatic VTE (DVT, and / or PE) [1 (0.3%) vs 9 (2.7%) patients, respectively] including two fatal PE reported in the placebo group.
Danish: Fondaparinux medførte også en signifikant reduktion af forekomsten af symptomatiske, venøse tromboemboliske komplikationer (dyb venetrombose og/eller lungeemboli) [henholdsvis 1 patient (0,3 %) kontra 9 patienter (2,7 %)], herunder to fatale tilfælde af lungeemboli rapporteret i placebogruppen.
English: The majority (70/80) of the recorded VTE events were venographically detected non-symptomatic cases of DVT.
Danish: Størstedelen (70/80) af de rapporterede venøse tromboemboliske komplikationer var ikke symptomatiske tilfælde, der blev påvist ved flebografi som dybe venetromboser.
English: Fondaparinux is contra-indicated in severe renal impairment (creatinine clearance <30 ml/min) and should be used with caution in patients with moderate renal impairment (creatinine clearance 30-50 ml/min).
Danish: Fondaparinux er kontraindiceret ved svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) og bør anvendes med forsigtighed til patienter med moderat nedsat nyrefunktion (kreatininclearance 30-50 ml/min).
English: In a pooled analysis of these studies, the recommended dose regimen of fondaparinux versus enoxaparin was associated with a significant decrease (54% - 95% CI, 44 %; 63%) in the rate of VTE evaluated up to day 11 after surgery, irrespective of the type of surgery performed.
Danish: En analyse af de samlede data fra disse studier fandt, at det anbefalede dosisregime af fondaparinux vs. enoxaparin medfører et signifikant fald (54 % - med 95 % konfidensinterval, 44-63 %) i forekomsten af tromboemboliske komplikationer vurderet frem til dag 11 efter indgrebet, uanset den udførte type kirurgi.
English: Clinical experience is limited in patients with body weight <50 kg. Fondaparinux should be used with caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2).
Danish: Der er begrænsede kliniske erfaringer hos patienter, der vejer < 50 kg. Fondaparinux bør anvendes med forsigtighed til denne patientgruppe og i en døgndosis på 5 mg (se pkt.
English: Clinical trials have shown a low but increased risk of guiding catheter thrombus in patients treated with fondaparinux for anticoagulation during PCI compared to control.
Danish: Sammenlignet med en kontrolgruppe har kliniske undersøgelser vist en lav, men forøget risiko for ledekateter-trombose hos patienter, der gennemgår PCI og behandles med fondaparinux som antikoagulans.
English: 5 mg once a day
Danish: 5 mg daglig.
English: Undesirable effects in patients undergoing major orthopaedic surgery of lower limbs and/or abdominal surgery
Danish: Bivirkninger hos patienter i større ortopædisk operation i underekstremiteterne og eller abdominal kirurgi
English: In those patients who underwent non-primary PCI 6-24 hours after the last dose of fondaparinux, the median dose of UFH was 8000 IU and the incidence of major bleeding was 2% (2/98).
Danish: Hos patienter, som fik foretaget ikke-primær PCI 6-24 timer efter sidste fondaparinuxdosis, var den mediane UFH-dosis 8000 IE, og incidensen af svær blødning var 2 % (2/98).
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 effekten af fondaparinux til behandling af dyb venetrombose (DVT) og lungeemboli (PE).
English: LIST OF EXCIPIENTS Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også: natriumchlorid, vand til injektionsvæsker, saltsyre, natriumhydroxid.
English: Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
Danish: Glaxo Group Ltd Greenford Middlesex UB6 0NN Storbritannien
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).
Danish: Behandling af ustabil angina eller non-ST segment elevations myokardieinfarkt (UA/NSTEMI) hos patienter, hvor en omgående (< 120 minutter) invasiv behandling (PCI) ikke er indiceret (se pkt.
English: The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) and 11.1% (2/18) respectively, and in patients receiving the recommended regimen of unfractionated heparin in the treatment of PE were 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.7% (3/28), respectively.
Danish: De tilsvarende incidenser hos patienter, der får den anbefalede behandling for DVT med enoxaparin var 2,3 % (13/559), 4,6 % (17/368), 9,7 % (14/145) henholdsvis 11,1 % (2/18), mens indicensen hos patienter, der fik den anbefalede behandling med ufraktioneret heparin mod lungeemboli var henholdsvis 6,9 % (36/523), 3,1 % (11/352), 11,1 % (18/162) og 10,7 % (3/28).
English: Parts of the safety syringe
Danish: Sikkerhedssprøjtens forskellige dele:
English: Quixidar is used to:
Danish: Quixidar indeholder:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: · stomach ulcer
Danish: · mavesår.
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: Ved behandling af UA/NSTEMI og STEMI bør fondaparinux anvendes med forsigtighed til patienter, som samtidig behandles med andre stoffer, som øger risikoen for blødninger (f.eks. GP-IIb/IIIahæmmere eller fibrinolytika).
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: Behandling af ustabil angina eller non-ST segment elevations myokardieinfarkt (UA/NSTEMI) OASIS 5 var en dobbeltblindet, randomiseret, noninferioritetsundersøgelse af fondaparinux 2,5 mg subkutant én gang daglig versus enoxaparin 1 mg/kg subkutant to gange daglig til ca. 20.000 patienter med UA/NSTEMI.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Subkutan anvendelse Læs indlægssedlen før brug.
English: Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE with normal renal function, mild renal impairment, moderate renal impairment and severe renal impairment were 3.0 % (34/1132), 4.4 % (32/733), 6.6% (21/318), and 14.5 % (8/55) respectively.
Danish: Incidensen for blødninger hos patienter, der får den anbefalede behandling for dyb venetrombose eller lungeemboli med normal nyrefunktion eller mild, moderat eller svær nedsættelse af nyrefunktionen var henholdsvis 3,0 % (34/1132), 4,4 % (32/733), 6,6 % (21/318) og 14,5 % (8/55).
English: • Treatment of UA/NSTEMI and STEMI - For the treatment of UA/NSTEMI and STEMI, there are limited clinical data available on the use of fondaparinux 2.5mg once daily in patients with creatinine clearance between 20 and 30 ml/min.
Danish: • Behandling af UA/NSTEMI og STEMI - Der findes kun en begrænset mængde kliniske data vedrørende behandling af UA/NSTEMI og STEMI med 2,5 mg fondaparinux daglig til patienter med kreatininclearance mellem 20 og 30 ml/min.
English: Excipient(s): Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially sodium free.
Danish: Hjælpestof(fer): Indeholder under 1 mmol natrium (23 mg) pr. dosis og er derfor for praktiske formål natriumfri..
English: Marketing Authorization Holder: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom
Danish: Indehaver af markedsføringstilladelsen: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Storbritannien
English: • feeling sick or being sick (nausea or vomiting)
Danish: • sygdomsfølelse (kvalme eller opkastning)
English: In this study, the incidence of total VTE was 4.6% (47/1027) with fondaparinux, versus 6.1%: (62/1021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
Danish: I dette forsøg var forekomsten af VTE i alt 4,6 % (47/1027) med fondaparinux over for 6,1 % (62/1021) med dalteparin: odds risikoreduktion 25,8 % med 95% konfidensinterval -49,7 %-9,5 %.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 March 2002
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Incidences in non-primary PCI in UA/NSTEMI were 1.0% vs 0.3% (fondaparinux vs. enoxaparin) and in primary PCI in STEMI were 1.2% vs 0% (fondaparinux vs. control).
Danish: Incidensen i forbindelse med ikke-primær PCI var for UA/NSTEMI 1 % versus 0,3 % (fondaparinux versus enoxaparin), og ved primær PCI hos STEMI-patienter var incidensen 1,2 % versus 0 % (fondaparinux versus kontrolgruppe).
English: There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/min).
Danish: Der er ingen erfaringer med den undergruppe af patienter, som både har høj legemsvægt (> 100 kg) og moderat nedsat nyrefunktion (kreatininclearance 30-50 ml/min).
English: • Do not inject Quixidar into muscle.
Danish: • Quixidar må ikke gives som injektion i en muskel.
English: Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) vs 34 patients (10.5%), respectively].
Danish: Fondaparinux nedsatte den generelle forekomst af tromboemboliske komplikationer signifikant sammenlignet med placebo [hhv. 18 patienter (5,6 % og 34 patienter (10,5 %)].
English: • the solution is clear and colourless to slightly yellow and doesn't contain particles
Danish: • at opløsningen er klar og farveløs eller svag gul, samt ikke indeholder partikler.
English: - hypersensitivity to the active substance or to any of the excipients - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 20 ml/min.
Danish: - overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne - aktiv klinisk betydende blødning - akut bakteriel endokardit - alvorlig nedsat nyrefunktion defineret ved en kreatininclearance < 20ml/min
English: Do not inject a double dose to make up for a forgotten dose.
Danish: • Tag den manglende dosis så snart du kommer i tanke om den. Du må ikke indsprøjte en dobbeltdosis som erstatning for en glemt dosis.
English: Treatment of ST segment elevation myocardial infarction (STEMI) OASIS 6 was a double blind, randomised study assessing the safety and efficacy of fondaparinux 2.5 mg once daily, versus usual care (placebo (47%) or UFH (53%)) in approximately 12000 patients with STEMI.
Danish: OASIS 6 var en dobbeltblindet, randomiseret undersøgelse til vurdering af sikkerhed og effekt ved administration af fondaparinux 2,5 mg subkutant én gang daglig versus sædvanlig behandling (placebo (47 %) eller UFH (53 %)) blandt ca. 12.000 patienter med STEMI.
English: Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Danish: Endvidere nedsatte fondaparinux signifikant forekomsten af fatal PE ifølge bedømmelse [hhv. 0 patienter (0,0 %) og 5 patienter (1,2 %)].
English: Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below.
Danish: Fondaparinux bør anvendes med forsigtighed til patienter med øget blødningstendens, herunder patienter med medfødt eller erhvervet blødersygdom (fx trombocyttal<50.000/mm3), aktiv gastrointestinal ulceration og nylig intrakraniel blødning samt kort tid efter hjerne-, ryg- eller øjenkirurgi og til særlige patientgrupper, se nedenfor.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity.
Danish: Der er ikke observeret nogen speciel fare for mennesker i ikke kliniske data baseret på traditionelle studier af sikkerhedsfarmakologi.
English: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom Manufacturer:
Danish: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Storbritannien Fremstiller:
English: Take special care with Quixidar:
Danish: Vær ekstra forsigtig med at bruge Quixidar:
English: • pain and swelling at injection site
Danish: • smerte og hævelser ved indstikstedet
English: This stops a clotting factor Xa (“ten-A”) from working in the blood, and so prevents unwanted blood clots (thromboses) from forming in the blood vessels.
Danish: Dette forhindrer koagulationsfaktor Xa (”ti-A”) i at fungere i blodet, og forebygger derved dannelsen af uønskede blodpropper (trombose) i blodkarrene.
English: In the pivotal UA/NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.
Danish: I det tilgrundlæggende UA/NSTEMI-studie blev fondaparinuxbehandlingen ikke genoptaget før tidligst 2 timer efter fjernelsen af sheath.
English: Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Danish: Fondaparinux giver ikke krydsreaktion med sera fra patienter med heparin-induceret trombocytopeni.
English: Contact your doctor or pharmacist before stopping.
Danish: Kontakt din læge eller apotek ved ophør med behandling tidligere end planlagt.
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 %) kontra 77 patienter (35 %)].
English: In the pivotal STEMI clinical trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.
Danish: I det tilgrundlæggende STEMI-studie blev fondaparinuxbehandlingen ikke genoptaget før tidligst 3 timer efter fjernelsen af sheath.
English: The majority of endpoint events were diagnosed by a prescheduled venography and consisted mainly of distal DVT, but the incidence of proximal DVT was also significantly reduced.
Danish: De fleste endpoint-hændelser blev diagnosticeret ved planlagt flebografi og bestod især af distal dyb venetrombose.
English: In DVT and PE treatment, patients receiving fondaparinux 5 mg (body weight <50 kg), 7.5 mg (body weight 50-100 kg inclusive) and 10 mg (body weight >100 kg) once daily, the body weight-adjusted doses provide similar exposure across all body weight categories.
Danish: Under behandling af DVT og PE hos patienter, der fik fondaparinux 5 mg (legemsvægt < 50 kg), 7,5 mg (legemsvægt 50-100 kg begge inklusive) og 10 mg (legemsvægt > 100 kg) en gang daglig, gav doserne tilpasset legemsvægt samme eksponering i alle vægtklasser.
English: For prevention of VTE, agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Danish: For at undgå VTE bør præparater, der kan øge blødningsrisikoen, bør ikke anvendes sammen med fondaparinux.
English: The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively.
Danish: Den tilsvarende incidens hos patienter, der fik den anbefalede behandling med enoxaparin for dyb venetrombose, var henholdsvis 2,5 %, 3,6 % og 8,3 %, mens incidensen hos patienter, der fik den anbefalede behandling med ufraktioneret heparin for lungeemboli var henholdsvis 5,5 %, 6,6 % og 7,4 %.
English: Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.
Danish: Hvis du har taget for meget Quixidar Kontakt så hurtigt som muligt din læge eller apotek for hjælp, da der er øget risiko for blødninger.
English: Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4).
Danish: Risikoen for blødninger er øget ved samtidig administration af fondaparinux og andre præparater der kan øge blødningsrisikoen (se pkt.
English: In the subgroup of patients treated with fondaparinux or enoxaparin who underwent PCI, 8.8% and 8.2% of patients respectively, experience death/MI/RI within 9 days of randomisation (hazard ratio 1.08, 95% CI, 0.92;1.27).
Danish: I undergruppen af patienter der blev behandlet med fondaparinux eller enoxaparin, og som fik foretaget PCI, var incidensen af død/MI/RI hhv. 8,8 % og 8,2 % 9 dage efter randomiseirngen (hazard rate 1,08; 95 % CI 0,92-1,27).
English: STEP BY STEP GUIDE TO USING QUIXIDAR
Danish: VEJLEDNING I BRUG AF QUIXIDAR (trin for trin) Instruktion
English: • reduction or increase in the number of platelets (blood cells necessary for blood clotting)
Danish: • nedsat eller øget antal blodplader (får blodet til at størkne)
English: The fondaparinux clinical program was designed to demonstrate the efficacy of fondaparinux for the prevention of venous thromboembolic events (VTE), i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Danish: Fondaparinux kliniske forsøgsprogram var tilrettelagt med henblik på at påvise effekten af fondaparinux til forebyggelse af venøse tromboemboliske komplikationer (VTE), dvs. proksimal og distal dyb venetrombose og lungeemboli hos patienter, som skulle have foretaget større ortopædkirurgiske indgreb i underekstremiteterne som fx ved hoftefraktur og knæ- eller hofteledsalloplastik.
English: Patients with Heparin Induced Thrombocytopenia Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT) type II.
Danish: Patienter med heparin-induceret trombocytopeni Fondaparinux binder ikke til P-koagulationsfaktor 4, og det giver ikke krydsreaktion med sera fra patienter med heparin-induceret trombocytopeni type II (HIT II).
English: - hypersensitivity to the active substance or to any of the excipients - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 30 ml/min.
Danish: - overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne - aktiv klinisk betydende blødning - akut bakteriel endokardit - alvorlig nedsat nyrefunktion (kreatininclearance < 30 ml/min).