FrancophonIA/ELRC3.0 huggingface dataset:
English: For treatment of superficial-vein thrombosis - Fondaparinux should be used with caution in patients who are being treated concomitantly with other medicinal products that increase the risk of haemorrhage.
Icelandic: - Gæta skal varúðar við notkun fondaparinux hjá sjúklingum sem eru samhliða í meðferð með öðrum lyfjum sem auka hættu á blæðingum.
English: The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
Icelandic: Tíðni bláæðasegareks með einkennum þ.á m. lungnasegareks var ekki marktækt mismunandi milli meðferðarhópanna.
English: Elimination
Icelandic: Útbrot
English: Where the instruction for a syringe is different this is clearly stated.
Icelandic: Skýrt er tekið fram þar sem munur er á leiðbeiningum fyrir sprauturnar.
English: Arixtra is a medicine that helps prevent blood clots from forming in the blood vessels (an antithrombotic agent).
Icelandic: Arixtra er lyf sem stuðlar að því að koma í veg fyrir að blóðtappar myndist í æðum
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa.
Icelandic: Segavarnarvirkni fondaparinux er afleiðing sértækrar hömlunar andtrombín III á storkuþætti Xa.
English: By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by antithrombin.
Icelandic: Með því að bindast andtrombíni sértækt eflir fondaparinux (um 300 falt) eðlilega hlutleysingu andtrombíns á storkuþætti Xa.
English: Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Icelandic: Arixtra 7,5 mg/0,6 ml stungulyf, lausn, áfyllt sprauta.
English: The needle shield of the pre-filled syringe may contain dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.
Icelandic: Nálarhlífin á áfylltu sprautunni getur innihaldið þurrt náttúrulegt latexgúmmí sem hugsanlega getur valdið ofnæmisviðbrögðum hjá einstaklingum sem eru viðkvæmir fyrir latexi.
English: Therefore, fondaparinux is not recommended for the treatment of superficial-vein thrombosis in these patients (see section 4.2).
Icelandic: Notkun fondaparinux er því ekki ráðlögð við meðferð gegn blóðsega í grunnlægum bláæðum hjá þessum sjúklingum (sjá kafla 4.2).
English: However, rare spontaneous reports of HIT in patients treated with fondaparinux have been received.
Icelandic: Eftir markaðssetningu lyfsins hefur þó verið tilkynnt um blóðflagnafæð af völdum heparíns í mjög sjaldgæfum tilvikum hjá sjúklingum sem hafa fengið meðferð með fondaparinux.
English: Haemorrhage
Icelandic: Lyfhrif
English: Hepatobiliary disorders Uncommon: abnormal liver function, hepatic enzymes increased
Icelandic: Óeðlileg lifrarstarfsemi, hækkun lifrarensíma
English: Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%).
Icelandic: Cmax (mg/l)0,39 (31%), Tmax (klst.) - 2.8 (18%) og Cmin (mg/l) - 0,14 (56%).
English: Rare: allergic reaction (including very rare reports of angioedema, anaphylactoid/anaphylactic reaction)
Icelandic: Ofnæmisviðbrögð (m.a. hefur örsjaldan verið greint frá ofsabjúgi, óþols/bráðaofnæmisviðbrögðum).
English: Incidence
Icelandic: Mæði
English: Each pre-filled syringe contains 5 mg of fondaparinux sodium in 0.4 ml solution for injection.
Icelandic: Hver áfyllt sprauta inniheldur 5 mg af fondaparinuxnatríum í 0,4 ml af stungulyfi, lausn.
English: Hepatic impairment
Icelandic: Lág líkamsþyngd
English: Renal impairment Fondaparinux is known to be mainly excreted by the kidney.
Icelandic: Skert nýrnastarfsemi Vitað er að fondaparinux er aðallega útskilið um nýru.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Icelandic: VIRK(T) EFNI
English: The needle shield of the pre-filled syringe contains dry natural latex rubber that has the potential to cause allergic reactions in latex sensitive individuals.
Icelandic: Nálarhlífin á áfylltu sprautunni inniheldur þurrt náttúrulegt latexgúmmí sem hugsanlega getur valdið ofnæmisviðbrögðum hjá einstaklingum sem eru viðkvæmir fyrir latexi.
English: For prevention of VTE- Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Icelandic: Til þess að fyrirbyggja bláæðasegarek, skal ekki gefa lyf sem geta aukið blæðingarhættu samtímis fondaparinux.
English: STEP BY STEP GUIDE TO USING ARIXTRA
Icelandic: NOTKUNARLEIÐBEININGAR, SKREF FYRIR SKREF Leiðbeiningar um notkun
English: • leg pain or stomach pain
Icelandic: Verkir í fótleggjum eða magaverkir
English: • 5 mg fondaparinux sodium in 0.4 ml solution for injection
Icelandic: 5 mg af fondaparinux natríum í 0,4 ml af stungulyfi, lausn.
English: Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Icelandic: Hver áfyllt sprauta (0,5 ml) inniheldur 2,5 mg af fondaparinuxnatríum.
English: Fondaparinux should be used with caution in elderly patients (see section 4.2).
Icelandic: Fondaparinux skal notað með varúð hjá öldruðum sjúklingum (sjá kafla 4.2 ).
English: In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
Icelandic: Tíðni alvarlegra blæðinga hjá sjúklingum sem í upphafi gengust ekki undir meðferð til að opna fyrir blóðflæðið, var 1,2% fyrir fondaparinux á móti 1,5% fyrir viðmiðunarhóp.
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).
Icelandic: Skammtinn skal lækka niður í 1,5 mg einu sinni á dag hjá sjúklingum með kreatínínúthreinsun á bilinu 20 til 50 ml/mín.
English: • chest pain
Icelandic: HEITI LYFS
English: The solution is a clear and colourless to slightly yellow liquid.
Icelandic: Lausnin er tær og litlaus eða gulleitur vökvi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Icelandic: Ein áfyllt sprauta (0,8 ml) inniheldur 10 mg fondaparinux natríum.
English: Treatment of patients with acute symptomatic spontaneous superficial-vein thrombosis without concomitant Deep-Vein Thrombosis (DVT)
Icelandic: Meðferð hjá sjúklingum með bráðan sjálfsprottinn blóðsega í grunnlægum bláæðum sem veldur einkennum án samhliða blóðsega í djúpum bláæðum (DVT)
English: • 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
Icelandic: 7,5 mg af fondaparinux natríum í 0,6 ml af stungulyfi, lausn.
English: Store below 25°C.
Icelandic: Geymið við lægri hita en 25°C. Má ekki frjósa.
English: Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Icelandic: Arixtra 1,5 mg/0,3 ml stungulyf, lausn, áfyllt sprauta.
English: Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk for thromboembolic complications due to restricted mobility during acute illness In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once daily or placebo for 6 to 14 days.
Icelandic: Í slembiraðaðri tvíblindri klínískri rannsókn fengu 839 sjúklingar meðferð með fondaparinux 2,5 mg einu sinni á dag eða lyfleysu í 6 til 14 daga.
English: Therefore adjunctive UFH should be used during non-primary PCI according to standard practice (see posology in section 4.2).
Icelandic: Því skal nota viðbótarmeðferð með ósundurgreindu heparíni meðan á kransæðavíkkun sem ekki er bráð stendur, samkvæmt hefðbundnu verklagi (sjá skammta í kafla 4.2).
English: • syringe with yellow plunger and a manual safety system.
Icelandic: • sprauta með gulum stimpli og handvirku öryggiskerfi.
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.
Icelandic: Samsvarandi tíðni hjá sjúklingum sem fengu ráðlagða skammta af enoxaparíni við meðferð á segamyndun í djúpum bláæðum var 2,5% (< 65 ára), 3,6% (65-75 ára) og 8,3% (> 75 ára), á meðan tíðnin hjá sjúklingum sem fengu ráðlagða skammta af ósundurgreindu heparíni í meðferð á lungnasegareki var 5,5% (< 65 ára), 6,6% (65-75 ára) og 7,4% (> 75 ára).
English: • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums)
Icelandic: Blæðing (t.d. úr skurðsári, sári sem fyrir er í maga, blóðnasir, marblettir)
English: Fondaparinux should not be prescribed to pregnant women unless clearly necessary.
Icelandic: Fondaparinux á ekki að nota á meðgöngu nema brýna nauðsyn beri til.
English: Aspen Pharma Trading Limited Tél.
Icelandic: Aspen France Tél.:
English: Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Icelandic: Lyf sem hindra samloðun blóðflagna (asetýlsalisýlsýra), bólgueyðandi gigtarlyf (píroxícam) og dígoxín höfðu ekki milliverkanir við lyfjahvörf fondaparinux.
English: • pain and swelling at injection site
Icelandic: Verkur og þroti á stungustað
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; these adverse reactions should be interpreted within the surgical and medical context.
Icelandic: ≥ 1/1.000 til < 1/100 ; mjög sjaldgæfar: ≥ 1/10.000 til < 1/1.000; koma örsjaldan fyrir: < 1/10.000) og líffæraflokki eftir minnkandi alvarleika; þessar aukaverkanir skal túlka m.t.t. skurðaðgerðar og lyfjameðferðar.
English: There are no adequate data from the use of fondaparinux in pregnant women.
Icelandic: Ekki liggja fyrir neinar fullnægjandi rannsóknaniðurstöður um notkun fondaparinux á meðgöngu.
English: A total of 2,192 patients were treated; for both groups, patients were treated for at least 5 days and up to 26 days (mean 7 days).
Icelandic: 2.192 sjúklingar meðferð; það gilti um báða hópa að sjúklingar voru meðhöndlaðir í a.m.k.
English: The incidences of adjudicated guiding catheter thrombus were 0.1% (1/1002) and 0.5% (5/1024), in patients randomised to “standard dose” and “low dose” UFH respectively during PCI.
Icelandic: Tíðni blóðsega vegna leiðandi leggs var 0,1% (1/1.002) hjá sjúklingum sem slembiraðað var á „hefðbundinn skammt“ af ósundurgreindu heparíni og 0,5% hjá sjúklingum sem slembiraðað var á „lágan skammt“ af ósundurgreindu heparíni meðan á kransæðavíkkun stóð.
English: Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Icelandic: Arixtra 2,5 mg/0,5 ml stungulyf, lausn, áfyllt sprauta.
English: Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Icelandic: Ein áfyllt sprauta (0,3 ml) inniheldur 1,5 mg fondaparinux natríum.
English: • breathlessness
Icelandic: A. ÁLETRANIR
English: Prevention of VTE following Surgery
Icelandic: SÉRSTAKAR VARÚÐARRÁÐSTAFANIR VIÐ FÖRGUN LYFJALEIFA
English: Aspen Pharma Trading Limited Tel: 017776395/+44 (0) 1748 828 391
Icelandic: Tel: 00385 17776395
English: Immune system disorders
Icelandic: Sprauta með sjálfvirku kerfi
English: • syringe with a blue plunger and an automatic safety system
Icelandic: sprauta með bláum stimpli og sjálfvirku
English: Aspen Pharma Trading Limited Teл.
Icelandic: Aspen Pharmacare España S.L.
English: NAME OF THE MEDICINAL PRODUCT Arixtra 1.5 mg/0.3 ml solution for injection fondaparinux sodium
Icelandic: Arixtra 1,5 mg/0,3 ml stungulyf fondaparinux
English: NAME OF THE MEDICINAL PRODUCT Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Icelandic: Arixtra 10 mg/0,8 ml stungulyf fondaparinux
English: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture surgery treated for up to 24 days following an initial prophylaxis of 1 week In a randomised double-blind clinical trial, 737 patients were treated with fondaparinux 2.5 mg once daily for 7 +/- 1 days following hip fracture surgery.
Icelandic: Í slembiraðaðri tvíblindri klíniskri rannsókn voru 7.37 sjúklingar meðhöndlaðir með fondaparinux 2,5 mg einu sinni á dag í 7 +/- 1 dag eftir mjaðmarbrotsaðgerð.
English: Uncommon side effects
Icelandic: Jákvæð áhrif fondaparinux
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 haemorrhage 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.
Icelandic: Tíðni skilgreindra meiriháttar blæðinga var 2,1% (fondaparinux) á móti 4,1% (enoxaparín) allt að og að meðtöldum degi 9 í III.
English: NAME OF THE MEDICINAL PRODUCT Arixtra 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Icelandic: Arixtra 2,5 mg/0,5 ml stungulyf fondaparinux
English: Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe.
Icelandic: Arixtra 5 mg/0,4 ml stungulyf, lausn, áfyllt sprauta.
English: • coughing
Icelandic: Algengar:
English: NAME OF THE MEDICINAL PRODUCT Arixtra 7.5 mg/0.6 ml solution for injection fondaparinux sodium
Icelandic: Arixtra 7,5 mg/0,6 ml stungulyf fondaparinux
English: Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Icelandic: Lyf sem geta aukið blæðingarhættu skal ekki gefa samtímis fondaparinux.
English: • increase in the amount of non-protein nitrogen in the blood
Icelandic: Aukning á köfnunarefni í blóði sem ekki kemur frá próteinum
English: Primary
Icelandic: Meginniðurstaða
English: Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily started 12-24 hours after surgery.
Icelandic: eftir aðgerð var borið saman við enoxaparín 40 mg einu sinni á dag gefið fyrst 12 klst.
English: Arixtra contains sodium
Icelandic: Arixtra inniheldur natríum
English: Syringe automatic system
Icelandic:  Nálarhlíf  Stimpill
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Icelandic: Ein áfyllt sprauta (0,6 ml) inniheldur 7,5 mg fondaparinux natríum.
English: Similarly, in UA/NSTEMI patients with life threatening conditions that require urgent revascularisation, the use of fondaparinux prior to and during PCI is not recommended.
Icelandic: Hjá sjúklingum með hvikula hjartaöng/hjartadrep án ST-hækkunar í lífshættu, sem þarfnast bráðrar hjáveituaðgerðar (revascularisation), er heldur ekki mælt með notkun fondaparinux fyrir kransæðavíkkun eða meðan á aðgerðinni stendur.
English: • dizziness
Icelandic: INNIHALDSLÝSING
English: Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Icelandic: Skert nýrnastarfsemi - Gæta skal varúðar við notkun fondaparinux hjá sjúklingum með miðlungsmikla skerðingu á nýrnastarfsemi (sjá kafla 4.4).
English: • increase in some chemicals (enzymes) produced by the liver.
Icelandic: Hækkun sumra efna (ensíma) sem framleidd eru í lifur.
English: Distribution
Icelandic: Trading
English: PCI and risk of guiding catheter thrombus
Icelandic: Kransæðavíkkun og hætta á blóðsega vegna leiðandi leggs (guiding catheter)
English: In subjects undergoing PCI the incidence of adjudicated guiding catheter thrombus was 1.0% vs. 0.3% in fondaparinux vs. enoxaparin subjects, respectively.
Icelandic: Hjá einstaklingum sem gengust undir kransæðavíkkun var tíðni blóðsega vegna leiðandi leggs 1% hjá þeim sem fengu fondaparinux en 0,3% hjá þeim sem fengu enoxaparin.
English: Rare: bilirubinaemia
Icelandic: B. FYLGISEÐILL
English: The syringe needle shield may contain latex that has the potential to cause allergic reactions in latex sensitive individuals.
Icelandic: Nálarhlífin á sprautunni getur innihaldið latex, sem hugsanlega getur valdið ofnæmisviðbrögðum hjá einstaklingum sem eru viðkvæmir fyrir latexi.
English: • allergic reaction (including itching, swelling, rash)
Icelandic: Ofnæmisviðbrögð (þ.m.t. kláði, þroti, útbrot)
English: Fondaparinux does not bind to platelet factor 4 and does not cross-react with sera from patients with Heparin Induced Thrombocytopenia (HIT) type II.
Icelandic: Fondaparinux binst ekki blóðflagnaþætti 4 og hefur yfirleitt ekki víxlsvörun við sermi frá sjúklingum með blóðflagnafæð af völdum heparíns (HIT) af tegund II. Í mjög sjaldgæfum tilvikum hafa þó borist tilkynningar um blóðflagnafæð af völdum heparíns hjá sjúklingum sem meðhöndlaðir eru með fondaparinux.
English: The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis.
Icelandic: Þær aukaverkanir sem skráðar voru við notkun vegna bráðakransæðaheilkennis samræmast þeim aukaverkunum sem fram komu við fyrirbyggjandi meðferð gegn bláæðasegareki.
English: EU/1/02/206/024 - 2 pre-filled syringes with a manual safety system EU/1/02/206/025 - 10 pre-filled syringes with a manual safety system EU/1/02/206/026 - 20 pre-filled syringes with a manual safety system
Icelandic: öryggiskerfi EU/1/02/206/025 - 10 áfylltar sprautur með handvirku öryggiskerfi EU/1/02/206/026 - 20 áfylltar sprautur með handvirku öryggiskerfi
English: Arixtra 7.5 mg/0.6 ml solution for injection Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Icelandic: Arixtra 7,5 mg/0,6 ml stungulyf, lausn fondaparinux natríum
English: Your weight
Icelandic: Þyngd
English: In other studies or in post-marketing experience, rare cases of intracranial / intracerebral and retroperitoneal bleedings have been reported.
Icelandic: Eftir að lyfið koma á markað hefur í mjög sjaldgæfum tilvikum verið greint frá magabólgu, hægðatregðu og hækkun gallrauða í blóði.
English: NAME OF THE MEDICINAL PRODUCT Arixtra 5 mg/0.4 ml solution for injection fondaparinux sodium
Icelandic: Arixtra 5 mg/0,4 ml stungulyf fondaparinux
English: EU/1/02/206/021 - 2 pre-filled syringes with a manual safety system EU/1/02/206/022 - 10 pre-filled syringes with a manual safety system EU/1/02/206/023 - 20 pre-filled syringes with a manual safety system
Icelandic: öryggiskerfi EU/1/02/206/022 - 10 áfylltar sprautur með handvirku öryggiskerfi EU/1/02/206/023 - 20 áfylltar sprautur með handvirku öryggiskerfi
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).
Icelandic: Við meðferð á hvikulli hjartaöng/hjartadrepi án ST-hækkunar og hjartadrepi með ST-hækkun skal nota fondaparinux með varúð hjá sjúklingum sem fá samhliða meðferð með öðrum lyfjum sem auka blæðingarhættu (svo sem GPIIb/IIIa-hemlum og segaleysandi lyfjum).
English: Nervous system disorders Rare: anxiety, somnolence, vertigo, dizziness, headache, confusion
Icelandic: Kviðverkir, meltingartruflanir, magabólgur, hægðatregða, niðurgangur.
English: EU/1/02/206/031 - 2 pre-filled syringes with a manual safety system EU/1/02/206/032 - 10 pre-filled syringes with a manual safety system EU/1/02/206/035 - 20 pre-filled syringes with a manual safety system
Icelandic: öryggiskerfi EU/1/02/206/032 - 10 áfylltar sprautur með handvirku öryggiskerfi EU/1/02/206/035 - 20 áfylltar sprautur með handvirku öryggiskerfi
English: The syringe needle shield contains latex that has the potential to cause allergic reactions in latex sensitive individuals.
Icelandic: Nálarhlífin á sprautunni inniheldur latex, sem hugsanlega getur valdið ofnæmisviðbrögðum hjá einstaklingum sem eru viðkvæmir fyrir latexi.
English: EU/1/02/206/027 - 2 pre-filled syringes with a manual safety system EU/1/02/206/028 - 10 pre-filled syringes with a manual safety system EU/1/02/206/033 - 20 pre-filled syringes with a manual safety system
Icelandic: öryggiskerfi EU/1/02/206/028 - 10 áfylltar sprautur með handvirku öryggiskerfi EU/1/02/206/033 - 20 áfylltar sprautur með handvirku öryggiskerfi
English: Treatment of ST segment elevation myocardial infarction (STEMI) The recommended dose of fondaparinux is 2.5 mg once daily.
Icelandic: Ráðlagður skammtur af fondaparinux er 2,5 mg einu sinni á dag.
English: Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage (see section 4.4).
Icelandic: Gæta skal varúðar við notkun fondaparinux hjá sjúklingum sem eru í aukinni hættu gagnvart blæðingum (sjá kafla 4.4).
English: Tel: 316300212/+44 (0)1423 852 876 aspenmedinfo@professionalinformation.co.uk
Icelandic: Limited Tel.: 0048 221253376 aspenmedinfo@professionalinformation.co.uk
English: Patients eligible for fondaparinux 2.5 mg treatment should have acute, symptomatic, isolated, spontaneous superficial-vein thrombosis of the lower limbs, at least 5 cm long and documented by ultrasonographic investigation or other objective methods.
Icelandic: 2,5 mg hentar sjúklingum sem hafa bráðan, einangraðan, sjálfsprottinn blóðsega í grunnlægri bláæð í fótlegg sem veldur einkennum, a.m.k.
English: Presence of superficial-vein thrombosis greater than 3 cm from the sapheno-femoral junction should be confirmed and concomitant DVT should be excluded by compression ultrasound or objective methods prior to initiating treatment with fondaparinux.
Icelandic: Áður en meðferð með fondaparinux er hafin skal staðfesta að um blóðsega í grunnlægri bláæð meira en 3 cm frá mótum innanlæris- og lærisbláæða sé að ræða og útiloka samhliða blóðsega í djúpum bláæðum með ómskoðun (compression ultrasound) eða hlutlægum aðferðum.
English: • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
Icelandic: Virka innihaldsefnið er 1,5 mg af fondaparinux natríum í 0,3 ml af stungulyfi, lausn.
English: Aspen Pharma Trading Limited Tel.: 008001211566/+44 (0)1423 852 859 aspenmedinfo@professionalinformation.co.uk
Icelandic: Limited Tél/Tel: 0035 227861279 aspenmedinfo@professionalinformation.co.uk
English: EU/1/02/206/001 - 2 pre-filled syringes with an automatic safety system EU/1/02/206/002 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/003 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/004 - 20 pre-filled syringes with an automatic safety system
Icelandic: öryggiskerfi EU/1/02/206/003 - 10 áfylltar sprautur með sjálfvirku öryggiskerfi EU/1/02/206/004 - 20 áfylltar sprautur með sjálfvirku
English: EU/1/02/206/005- 2 pre-filled syringes with an automatic safety system EU/1/02/206/006 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/007 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/008 - 20 pre-filled syringes with an automatic safety system
Icelandic: öryggiskerfi EU/1/02/206/007 - 10 áfylltar sprautur með sjálfvirku öryggiskerfi EU/1/02/206/008 - 20 áfylltar sprautur með sjálfvirku
English: • syringe with a magenta plunger and an automatic safety system
Icelandic: • sprauta með fjólubláum stimpli og sjálfvirku öryggiskerfi.
English: Secondary
Icelandic: Frásog
English: • Treatment of superficial-vein thrombosis - There are no clinical data available for the use of fondaparinux for the treatment of superficial-vein thrombosis in patients with severe hepatic impairment.
Icelandic: - Engar klínískar upplýsingar liggja fyrir varðandi notkun fondaparinux við meðferð blóðsega í grunnlægum bláæðum hjá sjúklingum með alvarlega skerðingu á lifrarstarfsemi.
English: Package leaflet: Information for the user Arixtra 5 mg/0.4 ml solution for injection.
Icelandic: Upplýsingar fyrir notanda lyfsins Arixtra 2,5 mg/0,5 ml stungulyf, lausn
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Icelandic: Ein áfyllt sprauta (0,4 ml) inniheldur 5 mg fondaparinux natríum.