natgillin/translations-raw huggingface dataset:
Forekomsten af symptomatiske tromboemboliske komplikationer
The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
lg inklusive lungeemboli var ikke signifikant forskellig i behandlingsgrupperne.
ra In studies versus enoxaparin 40 mg once daily started 12 hours before surgery, major bleeding was
sa I studier, hvor fondaparinux blev sammenlignet med enoxaparin 40 mg en gang daglig med første administration 12 timer før indgrebet, blev der observeret større blødninger hos 2, 8% af de patienter, der fik fondaparinux i den anbefalede dosering, mens der blev set 2, 6% i enoxaparingruppen.
e observed in 2.8% of fondaparinux patients treated with the recommended dose, compared to 2.6% with enoxaparin.
til Forebyggelse af tromboemboliske komplikationer hos patienter opereret for hoftefraktur med
ng
et efterfølgende profylakse givet 7 dage plus op til 24 dage I et randomiseret, dobbeltblindt klinisk forsøg blev 737 patienter behandlet med fondaparinux 2, 5 mg en gang daglig i 7 ± 1 dag efter operation for hoftefraktur.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture lo 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.
Efter denne periode blev 656 patienter
At the end of this period, 656 patients were no
er randomiseret til behandling med fondaparinux 2, 5 mg en gang daglig eller placebo i yderligere 21 ± 2 dage.
randomised to receive fondaparinux 2.5 mg once daily or placebo for an additional 21 +/ - 2 days.
to tromboemboliske komplikationer sammenlignet med placebo [henholdsvis 3 patienter (1, 4%) kontra 77 patienter (35%)].
Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 patients (1.4%) vs 77 patients (35%), respectively].
Størstedelen (70/ 80) af de rapporterede venøse tromboemboliske komplikationer
The majority (70/ 80) of the recorded VTE events ct
au var ikke symptomatiske tilfælde, der blev påvist ved flebografi som dybe venetromboser.
were venographically detected non-symptomatic cases of DVT.
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 e placebogruppen.
Fondaparinux also provided a significant reduction in the rate of symptomatic VTE (DVT, and / or PE) [1 (0.3%) vs 9 (2.7%) du
Der blev rapporteret større blødninger ved operationsstedet, heraf ingen fatale, hos 8 er patienter (2, 4%) i behandling med 2, 5mg fondaparinux, mens det blev set hos 2 patienter (0, 6%) i placebogruppen. ng
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. ro
Forebyggelse af tromboemboliske komplikationer (VTE) hos patienter, der gennemgår abdominalkirurgi, med høj risiko for tromboemboliske komplikatoner, fx ved abdominalcancer læ
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery lP
I et dobbeltblindt klinisk forsøg blev 2927 patienter randomiseret til at få fondaparinux 2, 5 mg en gang daglig eller dalteparin 5000 IE en gang daglig, dog 2500 IE præoperativt og 2500 IE postoperativt første gang, i 7 + 2 dage.
The main sites of surgery were colonic/ rectal, gastric, hepatic, cholecystectomy or other biliary.
De primære operationsområder var colon/ rektum, ventrikel, lever og e
Sixty-nine percent of the patients underwent surgery for cancer. ici
Patienter, der blev opereret urologisk (ud over nyrerne), gynækologisk, laparoskopisk eller i kar, var ikke med i forsøget. ikk
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study. ed
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%.
In this study, the incidence of total VTE was 4.6% (47/ 1027) with fondaparinux, versus 6.1%:
Forskellen i den totale forekomst af VTE i de to grupper, som ikke var statistisk signifikant, skyldtes er
M
hovedsageligt en reduktion i asymptomatisk distal DVT.
The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due to a reduction of asymptomatic distal DVT.
I den store subgruppe af patienter, som gennemgik cancerkirurgi (69% af et
In the large subgroup of patients undergoing cancer surgery (69% of the patient population), the VTE rate was 4.7% in the fondaparinux group, versus 7.7% in the dalteparin group.
Der blev observeret større blødninger hos 3, 4% af patienterne i fondaparinuxgruppen over for hos 2, 4% i dalteparingruppen. m
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Forsøget omfattede akut syge patienter i aldersgruppen ≥60 år, som forventedes at skulle holde sengen i mindst 4 dage, og som var indlagt på grund af kronisk Læ
7 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.
hjerteinsufficiens (NYHA- klasse III/ IV) og/ eller akut respirationssygdom og/ eller akut infektiøs eller inflammatorisk sygdom.
This study included acutely ill medical patients, aged ≥ 60 years, expected to require bed rest for at least four days, and hospitalized for congestive heart failure NYHA class III/ IV and/ or acute respiratory illness and/ or acute infectious or inflammatory disease.
7 forekomsten af fatal PE ifølge bedømmelse [hhv.
d Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5
0 patienter (0, 0%) og 5 patienter (1, 2%)].
e patients (1.2%), respectively].
5. 2 Farmakokinetiske egenskaber
ris 5.2 Pharmacokinetic properties
sa Efter subkutan indgift absorberes fondaparinux fuldstændigt og hurtigt med en absolut biotilgængelighed på 100%.
ho Absorption After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
Efter en enkelt subkutan injektion af 2, 5 mg fondaparinux til unge raske forsøgspersoner opnås den maksimale plasmakoncentration (gennemsnitlig Cmax = 0, 34 mg/ l) 2 timer
Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects,
til efter indgift.
ut peak plasma concentration (mean Cmax = 0.34 mg/ l) is obtained 2 hours post-dosing.
et Hos ældre raske forsøgspersoner, fandtes fondaparinux farmakokinetik lineær i området 2- 8 mg ved subkutan indgift.
ra In elderly healthy subjects, pharmacokinetics of fondaparinux are linear in the range of 2 to 8 mg by subcutaneous route.
Ved en daglig dosis opnås steady state- plasmakoncentration efter 3- 4 dage med en
Following once daily dosing, steady state of plasma levels is obtained after 3 to 4
ris Estimaterne for middel- steady state (Coefficient Variation (CV)) farmakokinetiske parametre for hoftealloplastik- patienter, der får fondaparinux 2, 5 mg daglig, er:
e days with a 1.3-fold increase in Cmax and AUC. ng 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%) og Cmin (mg/ l) – 0, 14 (56%).
Cmax (mg/ l) - 0.39 lo (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/ l) -0.14 (56%).
Hos patienter med hoftefrakturer ses følgende steady state -
Cmax (mg/ l) - 0.50 (32%), no
Fordeling au Fondaparinux fordelingsvolumen er begrænset (7- 11 liter).
Distribution The distribution volume of fondaparinux is limited (7-11 litres).
In vitro bindes fondaparinux med høj e affinitet og specifikt til ATIII- protein, [hvilket giver en plasmakoncentrationsbinding] (98, 6- 97, 0% i er koncentrationsintervallet fra 0, 5 til 2 mg/ l).
Fondaparinux does not bind du
Fondaparinux bindes ikke væsentligt til andre plasmaproteiner, herunder platelet factor 4 (PF4). ng
significantly to other plasma proteins, including platelet factor 4 (PF4). ro
Da fondaparinux ikke bindes til andre plasmaproteiner end ATIII, er der ingen forventning om interaktion med andre lægemidler i form af proteinbindingssubstitution. læ
Since fondaparinux does not bind significantly to plasma proteins other than ATIII, no interaction with other medicinal products by protein binding displacement are expected. lP
Metabolisme Selvom en fuldstændig evaluering ikke foreligger, er der ikke fundet tegn på metabolisme af fondaparinux eller dannelse af aktive metabolitter. e ikk
Metabolism Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no na
Fondaparinux hæmmer ikke CYP450- enzymer (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 og CYP3A4) in vitro.
Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, ici
Derfor forventes det ikke, at fondaparinux vil interagere med andre lægemidler in vivo gennem hæmning af CYP- medieret metabolisme. er
Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism. ed
Udskillelse/ elimination Eliminationshalveringstiden (t½) er ca.
Excretion/ Elimination The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy M
21 timer hos raske ældre forsøgspersoner.
elderly subjects.
64- 77% af fondaparinux udskilles uændret via nyrerne. et
Fondaparinux is excreted to 64 – 77% by the kidney as unchanged compound.
Særlige befolkningsgrupper: idl
Special populations
Pædiatriske patienter - Fondaparinux er ikke undersøgt i denne patientgruppe. m
Paediatric patients - Fondaparinux has not been investigated in this population.
fondaparinux være reduceret hos ældre.
8 Elderly patients - Renal function may decrease with age and thus, the elimination capacity for fondaparinux may be reduced in elderly.
Læ
In patients > 75 years undergoing orthopaedic surgery, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients < 65 years.
Værdierne for
In severe renal impairment (creatinine clearance < 30 ml/ min), plasma clearance is approximately 5 times lower than in normal
8 terminal halveringstid var 29 timer hos patienter med moderat nedsat nyrefunktion, og 72 timer hos patienter med svært nedsat nyrefunktion.
Associated terminal half-life values were 29 h in moderate and 72 h in patients with
Køn - Der blev ikke observeret kønsspecifikke forskelle efter justering for legemsvægt.
ris Gender - No gender differences were observed after adjustment for body weight.
Imidlertid
ho Race - Pharmacokinetic differences due to race have not been studied prospectively.
sa påviste studier med asiatiske (japanske), raske forsøgspersoner ingen forskel i den farmakokinetiske profil ved sammenligning med kaukasiske, raske forsøgspersoner.
Similarly, no plasma clearance differences were observed
Der blev heller ikke observeret forskelle i plasmaclearance mellem sorte og kaukasiske patienter, som gennemgik ortopædkirurgi.
ut between black and Caucasian patients undergoing orthopaedic surgery.
til Legemsvægt - Plasmaclearance af fondaparinux stiger i takt med legemsvægten (9% for hver 10 kg).
ra Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
et Nedsat leverfunktion - Farmakokinetikken af fondaparinux er ikke evalueret hos patienter med nedsat leverfunktion.
Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.
er 5. 3 Prækliniske sikkerhedsdata
Preclinical safety data
ris Der er ikke observeret nogen speciel fare for mennesker i prækliniske data baseret på traditionelle
ng
to studier af sikkerhedsfarmakologi, toksikologi med gentagen indgift og gentoksikologi.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety lo pharmacology, repeated dose toxicity, and genotoxicity.
På grund af begrænset eksponering er de foreliggende dyreforsøg utilstrækkelige til at påvise eventuel effekt på
Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure. no
FARMACEUTISKE OPLYSNINGER e er 6. 1 Hjælpestoffer
PHARMACEUTICAL PARTICULARS ct
Natriumchlorid ng
6.1 List of excipients du
Vand til injektionsvæsker Saltsyre læ
Sodium chloride Water for injections ro
Natriumhydroxid
Hydrochloric acid Sodium hydroxide lP
6. 2 Uforligeligheder e
6.2 Incompatibilities na
Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, må denne medicin ikke ikk
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. ici
6. 3 Opbevaringstid er
6.3 Shelf life ed
6. 4 Særlige opbevaringsforhold et
6.4 Special precautions for storage M
Må ikke nedfryses. idl
Do not freeze.
6. 5 Emballagetyper og pakningsstørrelser m
9 6.5 Nature and contents of container
Type I- glascylinder (1 ml), hvorpå er monteret en kanyle 27 gauge og længde 12, 7 mm tilproppet med ge
Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper.
en bromobutyl eller chlorobutyl elastomerprop.
Quixidar is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a yellow automatic safety system.
sikkerhedssystem.
Not all pack sizes may be marketed.
9 Lægemidler til parenteral brug skal kontrolleres visuelt for partikelindhold og misfarvning før indgift.
ris Parenteral solutions should be inspected visually for particulate matter and discoloration prior to administration.
Instruktion i selvinjektion findes beskrevet i indlægssedlen.
ho Instruction for self-administration is mentioned in the Package Leaflet.
lg De fyldte Quixidar injektionssprøjter er forsynet med et system til beskyttelse af kanylen, som
ut The needle protection system of the Quixidar pre-filled syringe has been designed with an automatic safety system to protect from needle stick injuries following injection.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
ra Any unused product or waste material should be disposed of in accordance with local requirements.
til 7.
Glaxo
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
MARKETING AUTHORISATION HOLDER Group Ltd
et Glaxo Group Ltd
ng
er Greenford Middlesex
Greenford Middlesex no
ris UB6 0NN Storbritannien
UB6 0NN United Kingdom ct
to 8.
8.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
MARKETING AUTHORISATION NUMBERS du
EU/ 1/ 02/ 207/ 005- 008 au e er 9.
EU/ 1/ 02/ 207/ 005-008 ro
DATO FOR FØRSTE TILLADELSEN
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION lP
21. marts 2007 læ
21 March 2007 na
DATO FOR ÆNDRING AF TEKSTEN e
DATE OF REVISION OF THE TEXT ici
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs ikk
Detailed information on this medicinal product is available on the website of the European Medicines ed
(EMEAs) hjemmeside http: // www. emea. europa. eu / er et idl m ge Læ
Agency (EMEA) http: / /www. emea. europa. eu M
Quixidar 2, 5 mg/ 0, 5 ml injektionsvæske, opløsning, fyldt injektionssprøjte.
Quixidar 2.5 mg/ 0.5 ml solution for injection, pre-filled syringe.
sa Hver fyldt injektionssprøjte (0, 5 ml) indeholder 2, 5 mg fondaparinuxnatrium.
Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Indeholder under 1 mmol natrium (23 mg) pr. dosis og er derfor for praktiske formål natriumfri..
Contains less than 1 mmol of sodium (23 mg) per dose, and therefore is essentially
er 3.
ho 3.
to Opløsningen er en klar og farveløs væske.
The solution is a clear and colourless liquid.
au 4.
ra 4.
4. 1 Terapeutiske indikationer e er Forebyggelse af venøse tromboemboliske komplikationer (VTE) i forbindelse med større ortopædkirurgiske indgreb i underekstremiteterne som fx ved hoftefraktur og knæ - eller ng
e 4.1
hofteledsalloplastik.
Therapeutic indications
Forebyggelse af venøse tromboemboliske komplikationer (VTE) hos patienter, som gennemgår læ
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic lo surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. no
5. 1).
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). ct
Forebyggelse af venøse tromboemboliske komplikationer (VTE) hos medicinske patienter, som e
Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/ or acute du
skønnes at være i højrisikogruppen, og som er immobiliserede på grund af akut sygdom såsom ikk
respiratory disorders, and/ or acute infectious or inflammatory disease. ro
Behandling af ustabil angina eller non- ST segment elevations myokardieinfarkt (UA/ NSTEMI) hos er
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 lP
4. 4 og 5. 1). et
and 5.1).
Behandling af ST segment elevations myokardieinfarkt (STEMI) hos patienter, som behandles med fibrinolyse, eller som initielt ikke får andre former for reperfusionsterapi. idl m
Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with na
4. 2 Dosering og indgivelsesmåde Patienter, der gennemgår større ortopædisk eller abdominal operation ge
Patients undergoing major orthopaedic or abdominal surgery ed
Den anbefalede dosis fondaparinux er 2, 5 mg én gang daglig, som indgives postoperativt som subkutan injektion.
The recommended dose of fondaparinux is 2.5 mg once daily administered post-operatively by subcutaneous injection.
11 tromboemboliske komplikationer 9 dage efter operationen.
Experience shows that in patients undergoing hip fracture surgery, the risk of VTE continues beyond 9 days after surgery.
Et
11 Medical patients who are at high risk for thromboembolic complications based on an individual risk assessment The recommended dose of fondaparinux is 2.5 mg once daily administered by subcutaneous injection.
Behandling af ustabil angina/ non- ST segment elevations myokardieinfarkt (UA/ NSTEMI)
Treatment of unstable angina/ non- ST segment elevation myocardial infarction (UA/ NSTEMI) The recommended dose of fondaparinux is 2.5 mg once daily, administered by subcutaneous injection.
Behandlingen bør initieres så hurtigt som muligt efter diagnosen og fortsættes i op til maksimalt 8
Treatment should be initiated as soon as possible following diagnosis and continued for up to a
et dage, eller indtil patienten udskrives, såfremt dette sker tidligere.
d maximum of 8 days or until hospital discharge if that occurs earlier.
Hvis en patient skal have foretaget perkutan koronarintervention (PCI), skal ufraktioneret heparin
e If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as
er (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.
ris 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).
4. 4).
The timing of
ris Tidspunktet for genoptagelse af subkutan fondaparinux efter fjernelse af sheath bør besluttes ud fra en klinisk vurdering.
ho restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment.
I det tilgrundlæggende UA/ NSTEMI- studie blev fondaparinuxbehandlingen ikke
In the pivotal UA/ NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.
to genoptaget før tidligst 2 timer efter fjernelsen af sheath.
ut Treatment of ST segment elevation myocardial infarction (STEMI)
au Behandling af ST segment elevations myokardieinfarkt (STEMI) Den anbefalede fondaparinuxdosis er 2, 5 mg daglig.
ra The recommended dose of fondaparinux is 2.5 mg once daily.
Behandlingen bør initieres så hurtigt som muligt efter diagnosen og fortsættes i op til maksimalt 8 dage, eller indtil e patienten udskrives, såfremt dette sker tidligere. er
Treatment should be initiated as soon as possible following diagnosis and continued for up to a
4. 4).
e maximum of 8 days or until hospital discharge if that occurs earlier. ng 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 lo time since the last dose of fondaparinux (see section 4.4).
I det læ
In the pivotal STEMI clinical no
tilgrundlæggende STEMI- studie blev fondaparinuxbehandlingen ikke genoptaget før tidligst 3 timer efter fjernelsen af sheath. e
trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.
For STEMI - eller UA/ NSTEMI- patienter, som skal have foretaget koronararteriebypass- operation (CABG- operation), bør fondaparinux om muligt ikke gives i de 24 timer umiddelbart før operationen, ikk
In STEMI or UA/ NSTEMI patients who are to undergo coronary artery bypass graft (CABG) surgery, fondaparinux where possible, should not be given during the 24 hours before surgery and may be ct
og det kan genoptages 48 timer efter operationen. er
restarted 48 hours post-operatively. du
Særlige befolkningsgrupper
Special populations ro
Forebyggelse af VTE efter operation et
Prevention of VTE following Surgery In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in lP
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. idl
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. na
Injektionen m
The first fondaparinux administration should be given not earlier than 6 hours following surgical closure.
4. 4). ge
The injection should not be given unless haemostasis has been established (see section 4.4). ici
4. 3).
Renal impairment • Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine ed
kreatininclearance på 20 – 50 ml/ min.
clearance < 20 ml/ min (see section 4.3).
Dosisjustering er ikke påkrævet for patienter med mildt nedsat nyrefunktion (kreatininclearance > 50 ml/ min.).
> 50 ml/ min).
12 med en kreatininclearance > 20 ml/ min.
No dosage reduction is required for patients with creatinine clearance > 20 ml/ min.
4. 4).
In patients with severe hepatic impairment, fondaparinux should be used with care (see section 4.4).
lg Børn - Fondaparinux bør ikke anvendes til børn under 17 år p. g. a. manglende dokumentation for
12 Paediatric population - Fondaparinux is not recommended for use in children below 17 years of age due to a lack of data on safety and efficacy.
Injektionsstedet
Method of administration • Subcutaneous administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
et bør alternere mellem højre og venstre anterolaterale samt posterolaterale abdominalvæg.
Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall.
For at undgå spild af præparatet bør luftboblen ikke uddrives af den fyldte injektionssprøjte, inden
To avoid the loss of medicinal product when using the pre-