qanastek/EMEA-V3 huggingface dataset:
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.
riz Trattament ta ’ anġina mhux stabbli/ infart mijokardijaku mingħajr elevazzjoni tas- segment ST (UA/ NSTEMI)
Treatment should be initiated as soon as possible following diagnosis and continued for up to a
to Id- doża rakkomandata ta ’ fondaparinux hi ta ’ 2. 5 mg darba kuljum b’ injezzjoni subkutanja.
d maximum of 8 days or until hospital discharge if that occurs earlier.
aw massimu ta ’ 8 ġranet jew sakemm il- pazjent joħroġ mill- isptar jekk dan jiġri qabel.
e If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as
Jekk għandu jsir intervent koronarju minn ġol- ġilda (PCI) fuq pazjent, għandha tiġi amministrata l - eparina mhux frazzjonata (UFH) waqt il- PCI, skond il- prattika lokali u għandu jiġi kkunsidrat ir- riskju
The timing of
x potenzjali ta ’ fsada għal pazjent, kif ukoll il- ħin minn meta ngħatat l- aħħar doża ta ’ fondaparinux (ara
ho restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment.
Il- ħin meta għandha terġa tibda tingħata l- injezzjoni subkutanja ta ’ fondaparinux wara li titneħħa x- sheath għandu jiġi stabbilit skond il- ġudizzju kliniku.
In the pivotal UA/ NSTEMI clinical trial, treatment with fondaparinux was restarted no earlier than 2 hours after sheath removal.
Fil- prova klinika pivotali UA/ NSTEMI, trattament b’ fondaparinux reġa ’ nbeda mhux aktar kmieni minn sagħtejn wara li ħa tneħħiet ix- sheath. ’ g Trattament ta ’ infart mijokardijaku b’ elevazzjoni tas- segment ST (STEMI) Id- doża rakkomandata ta ’ fondaparinux hi ta ’ 2. 5 mg darba kuljum.
ut Treatment of ST segment elevation myocardial infarction (STEMI)
L- ewwel doża ta ’ fondaparinux im
ra The recommended dose of fondaparinux is 2.5 mg once daily.
għandha tingħata ġol- vina u d- dożi ta ’ wara jingħataw b’ injezzjoni subkutanja.
The first dose of fondaparinux is administered intravenously and subsequent doses are administered by subcutaneous injection.
It- trattament għandu jinbeda kemm jista jkun malajr wara d- dijanjosi u għandu jitkompla għal perjodu massimu ta ’ 8 ġranet jew sakemm il- pazjent joħroġ mill- isptar jekk dan jiġri qabel. li l
Treatment should be initiated as soon as possible following diagnosis and continued for up to a
Jekk għandu jsir intervent PCI mhux primarju fuq pazjent, għandha tiġi amministrata l- eparina mhux frazzjonata (UFH) waqt il- PCI, skond il- prattika lokali u għandu jiġi kkunsidrat ir- riskju potenzjali ta ’ na
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).
fsada għal pazjent, kif ukoll il- ħin minn meta ngħatat l- aħħar doża ta ’ fondaparinux (ara sezzjoni 4. 4).
The timing of restarting subcutaneous fondaparinux after sheath removal should be based on clinical judgment.
Il- ħin meta għandha terġa tibda tingħata l- injezzjoni subkutanja ta ’ Quixidar wara li titneħħa x- sheath għandu jiġi stabbilit skond il- ġudizzju kliniku.
In the pivotal STEMI clinical no
Fil- prova klinika pivotali STEMI, trattament iċi
trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.
b’ fondaparinux reġa ’ nbeda mhux aktar kmieni minn 3 sigħat wara li tneħħiet ix- sheath. ed
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
F’ pazjenti li jbatu minn STEMI jew UA/ NSTEMI li jridu jgħaddu minn kirurġija ta ’ bypass graft fl - arterja koronarja (CABG), fejn possibbli fondaparinux m’ għandux jingħata fl- 24 siegħa ta ’ qabel il - kirurġija u jista jerġa jinbeda 48 siegħa wara l- operazzjoni. tm
Special populations ro
Popolazzjonijiet speċjali ot
Prevention of VTE following Surgery In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in lP
Prevenzjoni ta ’ VTE wara l- kirurġija Għall- ewwel injezzjoni b’ fondaparinux hu importanti li jkun hemm aderenza stretta mal- ħin f’ pazjenti od
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
Pr
The first fondaparinux administration should be given not earlier than 6 hours following surgical closure.
L- ewwel amministrazzjoni ta ’ fondaparinux għandha tingħata mhux aktar kmieni minn 6 sigħat wara t- tmiem tal- kirurġija.
The injection should not be given unless haemostasis has been established (see section 4.4). ici
L- injezzjoni m’ għandiex tingħata jekk ma tkunx ġiet stabbilita l- emostażi.
Renal impairment • Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine ed
(ara sezzjoni 4. 4)
clearance < 20 ml/ min (see section 4.3).
Indeboliment renali • Profilassi ta ’ VTE - Fondaparinux m’ għandux jingħata lil pazjenti bi clearance tal- krejatinina < 20 ml/ min (ara sezzjoni 4. 3).
No dosage reduction is required for patients with mild renal impairment (creatinine clearance M
F’ pazjenti bi clearance tal- krejatinina ta ’ bejn 20 sa 50 ml/ min, 13 id- doża ta ’ fondaparinux għandha titnaqqas għal 1. 5 mg darba kuljum (ara sezzjonijiet 4. 4 u 5. 2).
> 50 ml/ min).
M’ hemmx bżonn li titnaqqas id- doża f’ pazjenti b’ indeboliment renali ħafif (clearance tal - krejatinina > 50 ml/ min)..
• Treatment of UA/ NSTEMI and STEMI - fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min (see section 4.3).
• Trattament ta ’ UA/ NSTEMI u STEMI – fondaparinux m’ għandux jingħata lil pazjenti bi clearance tal- krejatinina < 20 ml/ min (ara sezzjoni 4. 3).
No dosage reduction is required for patients with creatinine clearance > 20 ml/ min.
M’ hemmx bżonn titnaqqas id- doża f’ pazjenti bi clearance tal- krejatinina > 20 ml/ min.
Hepatic impairment - No dosing adjustment is necessary.
t za Indeboliment tal- fwied - Ma hemm bżonn ta ’ l- ebda aġġustament fid- doża.
In patients with severe hepatic impairment, fondaparinux should be used with care (see section 4.4).
(ara sezzjoni 4. 4).
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.
riz Popolazzjonijiet pedjatriċi - Fondaparinux mhux rakkomandat għall- użu fi tfal ta ’ taħt is- 17- il sena minħabba nuqqas ta ’ tagħrif dwar is- sikurezza u l- effikaċja.
Method of administration • Subcutaneous administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
aw • Amministrazzjoni subkutanja Fondaparinux huwa amministrat permezz ta ’ injezzjoni subkutanja fonda waqt li l- pazjent ikun mindud.
Sites of administration should alternate between the left and the right anterolateral and left and right posterolateral abdominal wall.
Biex tevita telf tal -
To avoid the loss of medicinal product when using the pre-
x prodott mediċinali waqt l- użu ta ’ l- injezzjoni mimlija lesta m’ għandekx tespella l- buzzieqa ta ’ l -
d filled syringe do not expel the air bubble from the syringe before the injection.
du arja minn ġos- siringa qabel l- injezzjoni.
The whole length
tinżamm matul l- injezzjoni.
e of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection.
Amministrazzjoni ġol- vina (l- ewwel doża f’ pazjenti ’ g
ris • Intravenous administration (first dose in patients with STEMI only)
bi STEMI biss)
ho Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
Biex tevita telf tal - im
The
prodott mediċinali waqt l- użu ta ’ l- injezzjoni mimlija lesta m’ għandekx tespella l- buzzieqa ta ’ l - arja minn ġos- siringa qabel l- injezzjoni.
If administered via a minibag, the infusion should be given
It- tubi li jgħaddu għal ġol- vina għandhom jitlaħalħu sew bis- saline wara l- injezzjoni biex t’ assigura li l- prodott mediċinali jingħata kollu.
ra over 1 to 2 minutes.
Jekk jingħata li l
For additional instructions for use and handling and disposal see section 6.6.
permezz ta ’ borża żgħira, l- infusjoni għandha tingħata fuq minuta għal 2 minuti.
- hypersensitivity to the active substance or to any of the excipients
Għal aktar struzzjonijiet għall- użu u maniġġar u għar- rimi ara sezzjoni 6. 6. na
lo
4. 3 Kontra- indikazzjonijiet iċi
4.4 Special warnings and precautions for use ct
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
Fondaparinux must not be administered intramuscularly. du
Fondaparinux m’ għandux jiġi amministrat b’ mod intramuskolari. ot
Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, ro
Emorraġija od
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 lP
Fondaparinux għandu jiġi amminstrat b’ kawtela f’ pazjenti li għandhom riskju akbar ta ’ emorraġija, bħal dawk li għandhom disturbi ta ’ fsadat konġeniti jew akkwiżiti (p. e. għadd taċ- ċelluli għat- tagħqid tad- demm < 50, 000/ mm3), mard ta ’ ulċera gastrointestinali attiv u emorraġija riċenti fil- kranju jew ftit Pr
ophthalmic surgery and in special patient groups as outlined below.
taż- żmien wara kirurġija fil- moħħ, fl- ispina jew kirurġija oftalmika jew fi gruppi ta ’ pazjenti speċjali kif spjegat hawn taħt.
concomitantly with fondaparinux.
Fil- prevenzjoni ta ’ VTE, aġenti li jistgħu jżidu r- riskju ta ’ emorraġija m’ għandhomx jiġu amministrati flimkien ma ’ fondaparinux.
These agents include desirudin, fibrinolytic agents, GP IIb/ IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH).
Dawn l- aġenti jinkludu desirudin, aġenti fibrinolitiċi, riċetturi antagonisti GP IIb/ IIIa, eparina, eparinojdi, jew Eparina ta ’ Piż Molekulari Baxx (LMWH).
When required, concomitant therapy with vitamin K antagonist should be administered in accordance with ici
Meta jkun hemm bżonn terapija konkomitanti ma ’ antagonist tal- vitamina K għandha tiġi amministrata skond l - 14 informazzjoni mogħtija f’ sezzjoni 4. 5.
If ed
Mediċini oħra li jxekklu l- plejtlets (acetylsalycylic acid, dipyridamole, sulfinpyrazone, ticlopidine jew clopidrogel), u NSAIDs għandhom jiġu wżati b’ kawtela.
M
Jekk il- ko- amministrazzjoni hija essenzjali, monitoraġġ bir- reqqa huwa neċessarju.
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).
Fit- trattament ta ’ UA/ NSTEMI u STEMI, fondaparinux għandu jintuża b’ kawtela f’ pazjenti li qed jirċievu fl- istess ħin aġenti oħra li jżidu r- riskju ta ’ emorraġija (bħal inibituri GP IIb/ IIIa jew trombolitiċi).
PCI and risk of guiding catheter thrombus In STEMI patients undergoing primary PCI, the use of fondaparinux prior to and during PCI is not recommended.
t za PCI u r- riskju ta ’ għoqda tad- demm minħabba l- kateter gwida F’ pazjenti b’ STEMI li qed jgħaddu minn PCI primarju, mhux rakkomandat l- użu ta ’ fondaparinux
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.
Bl- istess mod, f’ pazjenti b’ UA/ STEMI li qegħdin f’ riskju ta ’ mewt u li għandhom bżonn vaskularizzazzjoni mill- ġdid, l- użu ta ’ fondaparinux qabel u wara l- PCI mhux rakkomandat.
These are
Dawn huma pazjenti li qegħdin ibatu minn anġina rikurrenti jew rifrattorja assoċjata ma ’ devjazzjoni
13 patients with refractory or recurrent angina associated with dynamic ST deviation, heart failure, life- threatening arrhythmias or haemodynamic instability.
to ST dinamika, mard tal- qalb, arrhythmias li jistgħu jwasslu għal- mewt jew nuqqas ta ’ stabbilità emodinamika.
In UA/ NSTEMI and STEMI patients undergoing non-primary PCI, the use of fondaparinux as the sole anticoagulant during PCI is not recommended, therefore UFH should be used according to local practice (see section 4.2).
aw F’ pazjenti b’ UA/ STEMI u STEMI li qed jgħaddu minn PCI mhux primarju, mhux rakkomandat l- użu ta ’ fondaparinux bħala l- unika sostanza kontra l- koagulazzjoni tad- demm matul il- PCI, għalhekk għandha tintuża UFH skond il- prattika lokali (ara sezzjoni 4. 2).
In those patients who underwent non-primary PCI 6-24 hours after the
x du Hemm tagħrif limitat dwar l- użu ta ’ UFH waqt PCI mhux primarju f’ pazjenti li qed jirċievu trattament b ’ fondaparinux (ara sezzjoni 5. 1).
d last dose of fondaparinux, the median dose of UFH was 8000 IU and the incidence of major bleeding
F’ dawk il- pazjenti li għaddew minn PCI mhux primarju 6- 24 siegħa wara l- aħħar doża ta ’ fondaparinux, id- doża medja ta ’ UFH kienet ta ’ 8000 IU u l- inċidenza ta ’ ħa fsada maġġuri kienet ta ’ 2% (2/ 98).
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%
F’ dawk il- pazjenti li għaddew minn PCI mhux primarju < 6 sigħat wara l- aħħar doża ta ’ fondaparinux, id- doża medja ta ’ UFH kienet ta ’ 5000 IU u l- inċidenza ta ’ fsada ’ g maġġuri kienet ta ’ 4. 1% (2/ 49). im
ho 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.
Provi kliniċi wrew li f’ pazjenti li rċevew fondaparinux bħala l- uniku trattamenet kontra l - koagulazzjoni tad- demm waqt PCI kien hemm riskju baxx iżda ogħla ta ’ għoqda tad- demm minħabba l- kateter gwida meta komparat mal- kontrol.
Incidences in non-primary PCI in UA/ NSTEMI were 1.0% vs 0.3% (fondaparinux vs. enoxaparin) and in primary PCI in STEMI were
L- inċidenzi f’ PCI mhux primarju f’ UA/ NSTEMI kienu ta ’ 1. 0% kontra 0. 3% (fondaparinux kontra enoxaparin) u f’ PCI primarju f’ STEMI kienu ta ’ 1. 2% kontra li l
ut 1.2% vs 0% (fondaparinux vs. control).
0% (fondaparinux kontra l- kontroll). na
ra Spinal / Epidural anaesthesia In patients undergoing major orthopaedic surgery, epidural or spinal haematomas that may result in long-term or permanent paralysis cannot be excluded with the concurrent use of fondaparinux and
Anesteżija spinali/ epidurali F’ pazjenti li jgħaddu minn kirurġija ortopedika maġġuri, ematomi epidurali jew spinali li jistgħu jirriżultaw f’ paraliżi permanenti jew għal żmien twil ma jistgħux jiġu esklużi bl- użu konkorrenti ta ’ iċi
e spinal/ epidural anaesthesia or spinal puncture.
Quixidar u anesteżija spinali jew epidurali jew titqib spinali.
The risk of these rare events may be higher with post- ng operative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis. lo Elderly patients The elderly population is at increased risk of bleeding.
Ir- riskju ta ’ dawn l- avventimenti rari jista ’ jkun ogħla b’ użu post- operattiv ta ’ kateter epidurali ġewwa l- ġisem jew l- użu konkomitanti ta ’ ed
As renal function is generally decreasing with no
Minħabba li l- funzjoni renali ġeneralment tonqos bl- eta`, pazjenti anzjani jista ’ jkollhom tnaqqis fl- eliminazzjoni u espożizzjoni akbar għal fondaparinux (ara sezzjoni 5. 2).
age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
sezzjoni 4. 2). od
Low body weight Patients with body weight < 50 kg are at increased risk of bleeding.
Piż tal- gisem baxx Pazjenti li għandhom piż < 50 kg għandhom riskju ikbar ta ’ fsada.
Fondaparinux should be used with caution in these patients (see section 4.2). du
Pr
Fondaparinux is known to be mainly excreted by the kidney. lP
Indeboliment renali Fondaparinux hu magħruf li jiġi mneħħi prinċipalment mill- kliewi.
• 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).
• Profilassi ta ’ VTE - Pazjenti bi clearance tal- krejatinina ta ’ < 50 ml/ min għandhom riskju akbar ta ’ fsada u VTE w għandhom jiġu trattati b’ kawtela (ara sezzjonijiet 4. 2, 4. 3 u 5. 2).
There are limited clinical data available from patients with creatinine clearance less than 30 ml/ min. na
Hemm tagħrif kliniku limitat fuq pazjenti bi clearance tal- krejatinina ta ’ anqas minn 30 ml/ min.
• 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 ici
15 • Trattament ta ’ UA/ NSTEMI u STEMI – Għat- trattament ta ’ UA/ NSTEMI u STEMI, hemm tagħrif kliniku limitat dwar l- użu ta ’ 2. 5mg ta ’ fondaparinux darba kuljum f’ pazjenti bi clearance tal- krejatinina bejn 20 u 30 ml/ min.
creatinine clearance between 20 and 30 ml/ min.
Indeboliment epatiku qawwi
Severe hepatic impairment Dosing adjustment of fondaparinux is not necessary.
t Mhux neċessarju li jsir aġġustament fid- doża ta ’ fondaparinux.
However, the use of fondaparinux should be M
Izda, l- użu ta ’ fondaparinux għandu
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).
za jiġi kkunsidrat b’ kawtela minħabba riskju akbar ta ’ fsada minħabba nuqqas ta ’ fatturi koagulanti f’ pazjenti b’ indeboliment epatiku qawwi (ara sezzjoni 4. 2).
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.
riz Pazjenti bi tromboċitopenja indotta bl- Eparina Fondaparinux ma jintrabatx mal- fattur 4 tal- plejtlets u ma jirreaġixxix mas- serum minn pazjenti b ’
The efficacy and safety of fondaparinux have not been formally studied in patients with HIT type II.
L- effikaċja u s- sigurta` ta ’ fondaparinux ma ġewx studjati formalment f’ pazjenti b ’ TIE tat- tip II.
14 4.5 Interaction with other medicinal products and other forms of interaction
aw 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4).
du r- riskju ta ’ emorraġija (ara sezzjoni 4. 4).
Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Sostanzi orali kontra l- koagulazzjoni tad- demm (warfarin), impedituri għat- tgħaqid tad- demm ħa (acetylsalicylic acid), NSAIDs (piroxicam) u digoxin ma kellhomx interazzjoni mal- farmakokinetiċi ta ’ fondaparinux.
The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications.
Id- doża ta ’ fondaparinux (10 mg) fl- istudju ta ’ l- interazzjoni kienet ogħla mid- doża ’ g rakkomandata għall- indikazzjoni preżenti.
Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under
Fondaparinux lanqas ma influwenzat l- attivita` INR ta ’ warfarin, lanqas il- ħin ta ’ fsada taħt acetylsalicylic acid jew trattament ta ’ piroxicam, lanqas il - im
d acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
farmakokinetiċi ta ’ digoxin fi stat fiss.
e Follow-up therapy with another anticoagulant medicinal product
Terapija ta ’ tkomplija bi prodott mediċinali ieħor kontra l- koagulazzjoni tad- demm Jekk it- trattament ta ’ tkomplija għandu jkun mibdi bl- eparina jew LMWH, l- ewwel injezzjoni li l
ris If follow-up treatment is to be initiated with heparin or LMWH, the first injection should, as a general rule, be given one day after the last fondaparinux injection.
għandha, bħala regola ġenerali, tingħata ġurnata wara l- aħħar injezzjoni ta ’ fondaparinux. na
ho If follow up treatment with a Vitamin K antagonist is required, treatment with fondaparinux should be continued until the target INR value has been reached.
Jekk hemm bżonn ta ’ trattament ta ’ tkomplija b’ antagonist tal- vitamina K, trattament b’ fondaparinux għandu jitkompla sakemm il- valur mirat ta ’ l- INR jintlaħaq. iċi
ut 4.6 Pregnancy and lactation
4. 6 Tqala u Treddigħ ed
ra There are no adequate data from the use of fondaparinux in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ fondaparinux waqt it- tqala.
Animal studies are insufficient with respect to effects on pregnancy, embryo/ foetal development, parturition and postnatal
Studji fuq bhejjem m’ humiex biżżejjed rigward l- effetti fuq it- tqala u fuq l - iżvilupp ta ’ l- embriju/ fetu, ħlas u żvilupp wara t- twelid.
Fondaparinux should not be prescribed to pregnant women unless clearly necessary.
Fondaparinux m’ għandux jintuża waqt it- tqala jekk m’ hemmx bżonn ċar. tm
Fondaparinux is excreted in rat milk but it is not known whether fondaparinux is excreted in human lo milk.
Fondaparinux jitneħħa fil- ħalib tal- far imma m’ hemmx tagħrif dwar l- eskrezzjoni ta ’ fondaparinux fil - ħalib tas- sider fil- bniedem.
Breast-feeding is not recommended during treatment with fondaparinux.
Fit - ot
Oral absorption by the child is however unlikely. no
tarbija l- assorbiment mill- ħalq huwa improbabli. od Pr
4.7 Effects on ability to drive and use machines
16 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
No studies on the effect on the ability to drive and to use machines have been performed. ct
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
4.8 Undesirable effects du
4. 8 Effetti mhux mixtieqa
The safety of fondaparinux 2.5 mg has been evaluated in: ro
Is- sigurta` ta ’ fondaparinux 2. 5 mg ġiet evalwata fi:
- 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days
za iżjed minn 9 t’ ijiem
- 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis
- f’ 327 pazjent għaddejjin minn kirurġija ta ’ ksur ta ’ l- għadma tal- ġenbejn li ġew trattati għal 3
of 1 week
riz ġimgħat wara profilassi inizjali ta ’ ġimgħa
- 1407 patients undergoing abdominal surgery treated up to 9 days
- 1407 pazjent għaddejjin minn kirurġija ta ’ l- addomenu li ġew trattati mhux iżjed minn 9 t’ ijiem
- 425 medical patients who are at risk for thromboembolic complications treated up to 14 days
- 425 pazjenti mediċi li huma f’ riskju ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu li ġew trattati
na
to għal 14 il- ġurnata
- 10,057 patients undergoing treatment of UA or NSTEMI ACS
- 10, 057 pazjenti li qed jirċievu trattament għal UA jew NSTEMI ACS
- 6,036 patients undergoing treatment of STEMI ACS.
- 6, 036 pazjenti li qed jirċievu trattament għal STEMI ACS.
ici ed M
x (komuni ħafna: ≥ 1/ 10; komuni: ≥1/ 100 sa < 1/ 10; mhux komuni: ≥ 1/ 1, 000 sa ≤ 1/ 100;
15 For the prevention of VTE, 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.
du rari: ≥ 1/ 10, 000 sa ≤1/ 1, 000; rari ħafna ≤1/ 10, 000) u fis- sistema tal- klassifika tal- organi, bil- gravita` ta ’ l- effett mhux mixtieq dejjem jonqos; dawn l- effetti mhux mixtieqa għandhom jiġu interpretati fil - kuntest kirurġiku u mediku.
System organ class MedDRA
Sistema tal- klassifika
Undesirable effects in patients undergoing major orthopaedic
Effetti mhux mixtieqa ’ g
Undesirable effects in medical patients
Effetti mhux mixtieqa
d surgery of lower limbs and/ or abdominal surgery
f’ pazjenti li jgħaddu minn kirurġija ortopedika maġġuri im
e ris Infections and
f’ pazjenti mediċi
Rare: post-operative infection
tar- riġlejn u/ jew kirurġija ta ’ l - addomenu. li l
ho infestations
Rari: infezzjonijiet tal- feriti wara Infezzjonijiet u na
Blood and lymphatic
l- operazzjoni Infestazzjonijiet
Common: post-operative
Disturbi tad- demm u tas - Komuni: emorraġija wara iċi
Common: bleeding
Komuni: fsada (ematoma,
ut system disorders
sistema limfatika ed
haemorrhage, anaemia Uncommon: bleeding (epistaxis,
operazzjoni, anemija Mhux komuni: telf ta ’ demm
(haematoma, haematuria, haemoptysis, gingival bleeding)
ematurja, emoptisis, fsada tal - ħanek)
ra
tm
gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura,
(epistaxis, emoptisis gastro - intestinali, ematurja, ematoma) thromboċitopenja, purpura,
Uncommon: anaemia
Mhux komuni: anemija
e thrombocythaemia, platelet ng abnormal, coagulation disorder lo Immune system disorders Rare: allergic reaction no
thrombocitemja, plejtlet abnormali, mard tal - koagulazzjoni ot od
Metabolism and nutrition Rare: hypokalaemia disorders ct
Rari: reazzjonijiet allerġiċi
Nervous system disorders Rare: anxiety, somnolence, du
Disturbi fil- metaboliżmu Rari:
vertigo, dizziness, headache, confusion ro
Ipokalimja u n- nutrizzjoni
disorders lP
Disturbi fis- sistema nervuża
Rare: hypotension
Rari: anzjeta`, nagħas, vertigo, sturdament, uġigħ ta ’ ras, konfużjoni
Respiratory, thoracic and Rare: dyspnoea, coughing mediastinal disorders na
17 Rari: pressjoni tad- demm baxxa Disturbi vaskulari Disturbi respiratorji, toraċiċi u medjastinali
Uncommon: dyspnoea
Rari: qtugħ ta ’ nifs, sogħla
Gastrointestinal ici
Mhux komuni: qtugħ ta ’ nifs
Uncommon: nausea, vomiting
Disturbi gastro - intestinali
disorders ed
Mhux komuni: dardir, rimettar Rari: uġigħ ta ’ l- addomenu,
Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
t za indiġestjoni, gastrite, stitikezza, dijareja
Hepatobiliary disorders M
riz Disturbi fil- fwied u fil - marrara
Uncommon: hepatic enzymes increased, hepatic function
Mhux komuni: żieda fl- enżimi tal- fwied, funzjoni abnormali tal -
abnormal Rare: bilirubinaemia
to fwied Rari: żieda fil- bilirubin
16 Skin and subcutaneous tissue disorders
aw Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda
Uncommon: rash, pruritus
Mhux komuni: raxx, ħakk
General disorders and administration site conditions
x du Disturbi ġenerali u kundizzjonijiet ta ’ mnejn
Uncommon: oedema, oedema peripheral, fever, wound secretion Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital,
Mhux komuni: edema, edema periferali, deni, nixxija mill- ferita ħa
d flushing, syncope
jingħata
e ris In other studies or in post-marketing experience, rare cases of intracranial / intracerebral and retroperitoneal bleedings have been reported.
F ’ studji oħrajn jew f’ esperjenza ta ’ wara t- tqegħid tal- prodott fis- suq, ġew irrapurtati każijiet rari ta ’ fsada fil- kranju / fil- moħħ u retroperitonejali. li l
ho The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis.
Il- profil ta ’ effetti mhux mixtieqa li ġew irrappurtati fil- programm ACS huwa konsistenti ma ’ l- effetti mhux mixtieqa dentifikati għall- profilassi ta ’ VTE. na
ut Bleeding was a commonly reported event in patients with UA/ NSTEMI and STEMI.
L- effett ta ’ fsada ġie rrappurtat komunement f’ pazjenti b’ UA/ NSTEMI u STEMI.
The incidence of
Fl- istudju iċi
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.
UA/ NSTEMI fi Fasi III, l- inċidenza ta ’ każijiet iġġudikati bħala fsada maġġuri kienet ta ’ 2. 1% (fondaparinux) kontra 4. 1% (enoxaparin) sa d - 9 ġurnata, din inkluża u fl- istudju STEMI fi Fasi III, l - inċidenza ta ’ każijiet iġġudikati bħala emorraġija severa skond kriterji mmodifikati TIMI kienet ta ’ ed
1.4% (control [UFH/ placebo]) up to and including Day 9 in
1. 1% (fondaparinux) kontra 1. 4% (kontroll [UFH/ plaċebo]) sa d - 9 ġurnata, din inkluża. tm
e the Phase III STEMI study. ng In the Phase III UA/ NSTEMI study, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were headache, chest pain and atrial fibrillation. lo In the Phase III study in STEMI patients, the most commonly reported non-bleeding adverse events no
Fl- istudju UA/ NSTEMI fi Fasi III, l- effetti mhux mixtieqa li mhumiex relatati ma fsada, li ġew irrappurtati l- iżjed komunement (irrappurtati f’ mill- anqas 1% ta ’ suġġetti fuq fondaparinux) kienu uġigħ ta ’ ras, uġigħ fis- sider u fibrillazzjoni ta ’ l- atriju. ot
(reported in at least 1% of subjects on fondaparinux) were atrial fibrillation, pyrexia, chest pain, headache, ventricular tachycardia, vomiting, and hypotension.
Pr
4.9 Overdose ct du
4. 9 Doża eċċessiva
Fondaparinux doses above the recommended regimen may lead to an increased risk of bleeding.
Dożi ta ’ fondaparinux akbar mir- reġimen rakkomandat jistgħu jwasslu għal riskju akbar ta ’ fsada.
There is no known antidote to fondaparinux. ro
M’ hemmx antidotu għal fondaparinux
Overdose associated with bleeding complications should lead to treatment discontinuation and search for the primary cause.
18 Doża eċċessiva assoċjata ma ’ komplikazzjonijiet tal- fsada għandhom iwasslu għal waqfien tat - trattament u għandha ssir riċerka għall- kawża primarja.
Initiation of appropriate therapy such as surgical haemostasis, blood lP
Għandha tiġi kkunsidrata li tinbeda terapija xierqa bħal emostażi kirurġika, sostituzzjoni tad- demm, trasfużjoni mill- ġdid ta ’ plażma, plażmafereżi.
5.1 Pharmacodynamic properties ici
t za 5. 1 Tagħrif farmakodinamiku
Pharmacotherapeutic group: antithrombotic agents. ed
riz Kategorija farmakoterapewtika: aġent antitrombotiku Kodiċi ATC:
Pharmacodynamic effects M
to Effetti farmakodinamiċi
Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa).
aw Fondaparinux huwa impeditur sintetiku u selettiv ta ’ Fattur X attivat (Xa).
The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) mediated selective inhibition of Factor Xa.
L- attivita` antitrombotika ta ’ fondaparinux hija riżultat ta ’ impediment selettiv ta ’ Fattur Xa medjat b’ antithrombin III (ATIII).
Neutralisation of Factor Xa interrupts the blood coagulation cascade and inhibits both thrombin formation and thrombus development.
In- newtralizzazzjoni ta ’ Fattur Xa tinterrompi l -
Fondaparinux does not inactivate thrombin (activated Factor II) and has no effects on platelets.
x kaskata tal- koagulazzjoni tad- demm u tinibixxi kemm il- formazzjoni ta ’ l- enżima li tikkawża t- tagħqid
17 At the 2.5 mg dose, fondaparinux does not affect routine coagulation tests such as activated partial thromboplastin time (aPTT), activated clotting time (ACT) or prothrombin time (PT)/ International Normalised Ratio (INR) tests in plasma nor bleeding time or fibrinolytic activity.
Fondaparinux ma jinattivax l- enżima li tikkawża t- tagħqid tad- demm (Fattur II attivat) u m’ ghandux effetti fuq il- plejtlets. ħa Bid- doża ta ’ 2. 5 mg, fondaparinux ma jaffettwax testijiet tal- koagulazzjoni ta ’ rutina tad- demm bħal activated partial thromboplastin time (aPTT), activated clotting time (ACT) jew prothrombin time ’ g (PT) / International Normalised Ratio (INR), testijiet fil- ħin tal- plażma jew fsada jew attivita` fibronolitika. im
Fondaparinux does not cross-react with sera from patients with heparin-induced thrombocytopaenia.
Fondaparinux ma jagħmilx cross reaction ma ’ sera minn pazjenti bi tromboċitopenja indotta bl - eparina. li l
Clinical studies
Studji klinici na
d surgery of the lower limbs treated up to 9 days
Prevenzjoni ta ’ Eventi Tromboemboliċi fil- Vini (VTE) f’ pazjenti li għaddejjin minn kirurġija ortopedika maġġuri tal- parti t’ isfel tal- ġisem trattati sa ’ 9 t ’ ijiem Il- programm kliniku ta ’ fondaparinux kien diżinjat biex juri l- effikaċja ta ’ fondaparinux għall - iċi
e 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
prevenzjoni ta’ eventi tromboemboliċi fil- vini (VTE), jiġifieri trombożi fil- vini fondi prossimali u tat - truf u emboliżmu pulmonari (PE) f’ pazjenti għaddejjin minn kirurġija ortopedika maġġuri tal- parti ed
Over 8,000 patients (hip
t’ isfel tal- ġisem bħal frattura fil- ġenb, kirurġija maġġuri fl- irkoppa jew kirurġija għal sostituzzjoni tal - ġenb.
ho fracture – 1,711, hip replacement – 5,829, major knee surgery – 1,367) were studied in controlled Phase II and III clinical studies.
Iktar minn 8, 000 pazjent (frattura fil- ġenb – 1, 711, sostituzzjoni tal- ġenb - 5, 829, kirurġija maġġuri fl- irkoppa – 1, 367) ġew studjati fi studji kliniċi kontrollati Fażi II u III.
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
Fondaparinux 2. 5 mg tm
ut started 12-24 hours after surgery.
darba kuljum mibdija 6- 8 sigħat wara l- operazzjoni ġiet ipparagunata ma ’ enoxaparin 40 mg darba kuljum mibdija 12- il siegħa qabel il- kirurġija, jew 30 mg darbtejn kuljum mibdija 12- 24 siegħa wara l- kirurġija. ot
ra 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
F’ ġabra ta ’ analiżi ta ’ dawn l- istudji, ir- reġimen tad- doża rakkomandata ta ’ fondaparinux kontra od
e evaluated up to day 11 after surgery, irrespective of the type of surgery performed.
enoxaparin ġiet assoċjata ma ’ nuqqas sinifikattiv (54% - 95% CI, 44%; 63%) fir- rata ta ’ VTE evalwata sa jum 11 wara l- kirurġija, irrispettivament mit- tip ta ’ kirurġija li tkun saret.
The majority of endpoint events were diagnosed by a prescheduled venography and consisted mainly of distal DVT, ng but the incidence of proximal DVT was also significantly reduced.
Il- maġġoranza ta ’ l- eventi kienu jikkonsistu fil- parti l- kbira tagħhom minn DVT periferali, iżda l- inċidenza ta ’ DVT Pr
with enoxaparin.
prossimali kienet imnaqqsa b’ mod sinifikanti wkoll.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing hip fracture ct
L- inċidenza ta ’ VTE sintomatika, inkluż PE ma kienx differenti b’ mod sinifikanti bejn il- gruppi ta ’ trattament.
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 du
Fi studji ta ’ tqabbil kontra enoxaparin 40 mg darba kuljum mibdi 12- il siegħa qabel l- operazzjoni, fsada maġġuri kienet osservata f’ 2. 8% tal- pazjenti trattati bid- doża rakkomandata ta ’ fondaparinux, paragunati ma ’ 2. 6% b’ enoxaparin.
daily for 7 +/ - 1 days following hip fracture surgery.
19 Prevenzjoni ta ’ Eventi Tromboemboliċi fil- Vini (VTE) f’ pazjenti għaddejjin minn kirurġija għal ksur tal- ġenb trattati sa 24 jum wara l- profilassi inizzjali ta ’ ġimgħa 1 F’ prova klinika randomized double- blind, 737 pazjent ġew trattati b’ fondaparinux 2. 5 mg darba kuljum għal 7 + / - 1 ġranet wara kirurġija għal frattura fil- ġenb.
At the end of this period, 656 patients were randomised to receive fondaparinux 2.5 mg once daily or placebo for an additional 21 +/ - 2 days.
Fit- tmiem ta ’ dan il- perijodu, 656 pazjent ġew magħżula b’ mod randomised biex jirċievu fondaparinux 2. 5 mg darba kuljum jew plaċebo għal 21+ / - 2 ġranet addizzjonali.
Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 ro
Il -
The majority (70/ 80) of the recorded VTE events were venographically detected non-symptomatic cases of DVT.
t maġġoranza (70/ 80) ta ’ l- eventi VTE reġistrati kienu każijiet ta ’ DVT mingħajr sintomi li kienu
Major bleedings, all at surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg na
Fondaparinux ipprovda wkoll tnaqqis sinifikanti fir- rata ta ’ VTE sintomatiku (DVT, u/ jew PE) [1( 0. 3% 0 vs 9 (2. 7%) pazjenti, rispettivament] inklużi żewġ PE fatali
compared to 2 (0.6%) with placebo.
riz rrapurtati fil- grupp plaċebo.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery ici
Fsada maġġuri, kollha f’ siti kirurġiċi u mhux fatali, kienu osservati fi 8 pazjenti (2. 4%) trattati b’ fondaparinux 2. 5 mg ipparagunati ma ’ 2 (0. 6%) bil- plaċebo.
who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery ed
to Il- prevenzjoni ta ’ Każi Trombo- emboliċi Venużi (VTE) f ’ pazjenti li jgħaddu minn kirurġija ta ’ l- addomenu u li huma f’ riskju għoli ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu, bħal pazjenti
In a double-blind clinical study, 2927 patients were randomized to receive fondaparinux 2.5mg once daily or dalteparin 5000 IU once daily, with one 2500 IU preoperative injection and a first 2500 IU M
Il -
post-operative injection, for 7+2 days.
x postijiet prinċipali tal- kirurġija kienu fil- kolon/ rektum, fl- istonku, fil- fwied, tneħħija tal- bużżieqa tal -
The main sites of surgery were colonic/ rectal, gastric, hepatic, cholecystectomy or other biliary.
du marrara jew oħrajn fil- marrara.
Sixty-nine percent of the patients underwent surgery for cancer.
Disgħa u sittin fil- mija tal- pazjenti kellhom kirurġija għall- kanċer.
Patients under-going urological (other than kidney) or gynaecological surgery, laparoscopic surgery or vascular surgery were not included in the study.
Pazjenti li kellhom kirurġija uroloġika (minbarra tal- kliewi) jew ġinekoloġika, laparoskopika jew vaskulari ma kienux inklużi f’ dan l- istudju.
In this study, the incidence of total VTE was 4.6% (47/ 1027) with fondaparinux, versus 6.1%:
F’ dan l- istudju, l- inċidenza ta ’ VTE totali b ’ fondaparinux kien ta ’ 4. 6% (47/ 1027), meta mqabbel ’ g ma ’ 6. 1% (62/ 1021) b ’ dalteparin: reduzzjoni ta ’ l - odds ratio [95% CI] = - 25. 8% [- 49. 7%, 9. 5%].
(62/ 1021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
Id - differenza fir - rati ta ’ VTE totali bejn il- gruppi ta ’ trattament, li ma kienx statistikament sinifikanti, im
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.
kien l- biċċa l- kbira minħabba tnaqqis f ’ DVT fit- truf mhux sintomatiku.
The incidence of symptomatic DVT was similar between
L- inċidenza ta ’ DVT sintomatiku kien simili bejn il- gruppi ta ’ trattamenti:
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.
F’ sub- grupp kbir ta ’ pazjenti b’ kirurġija għall- kanċer (69% mill- pazjenti), ir- rata ta ’ VTE kienet ta ’ 4. 7% fil- grupp ta ’ fondaparinux, meta li l
Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
mqabbel ma ’ 7. 7% fil - grupp ta ’ dalteparin. na
Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk for thromboembolic complications due to restricted mobility during acute illness
Fsada maġġuri kienet osservata f ’ 3. 4% tal- pazjenti fil- grupp ta ’ fondaparinux u f ’ 2. 4% fil- grupp ta ’ dalteparin. iċi
d In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once
Il- prevenzjoni ta ’ Każi Trombo- emboliċi Venużi (VTE) f ’ pazjenti mediċi li huma f’ riskju għoli ta ’ kumplikazzjonijiet ta ’ trombo- emboliżmu minħabba nuqqas ta ’ mobilita` waqt mard akut: ed
e daily or placebo for 6 to 14 days.
Fi studju kliniku double- blind u randomised, 839 pazjent kienu trattati b ’ fondaparinux 2. 5mg darba kuljum jew bil- plaċebo għal 6 sa 14 il- ġurnata.
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
Dan l- istudju inkluda pazjenti mediċi b’ mard akut, b’ eta` ≥ 60 sena, li kienu mistennija li jkollhom bżonn mill- inqas erbat ijiem ta ’ serħan fis- sodda, u li tm
ris class III/ IV and/ or acute respiratory illness and/ or acute infectious or inflammatory disease.
ddaħħlu l- isptar minħabba insuffiċjenza tal- qalb konġestiva NYHA klassi III/ IV u / jew mard respiratorju akut u / jew mard akut infettiv jew ta ’ infjammazzjoni.
Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%)
Fondaparinux naqqas sinifikament ir- rata sħiha ta ’ VTE meta mqabbel ma ’ l- plaċebo [18 - il pazjent (5. 6%) vs 34 pazjenti (10. 5%), ot
ho vs 34 patients (10.5%), respectively].
rispettivament].
Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Fondaparinux naqqas sinifikament ukoll ir- rata ta ’ PE li kienu aġġudikati fatali [0 pazjenti (0. 0%) vs 5 pazjenti (1. 2%), od
ut Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/ NSTEMI)
Pr
ra 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.
20 Trattament ta ’ anġina mhux stabbli jew infart mijokardijaku mingħajr elevazzjoni tas- segment ST (UA/ NSTEMI) OASIS 5 kien studju double- blind, mhux magħmul fuq bażi ta ’ xi għażla, u biex juri li m’ hemmx inferjurità, bl- użu ta ’ 2. 5 mg fondaparinux taħt il- ġilda darba kuljum kontra 1 mg/ kg enoxaparin taħt il- ġilda darbtejn kuljum f’ madwar 20, 000 pazjent b’ UA/ NSTEMI.
All patients received standard medical treatment for UA/ NSTEMI,
Il- pazjenti kollha ġew mogħtija trattament mediku normali għal UA/ NSTEMI, bi 34% minnhom operati b’ PCI u 9% minnhom b’ CABG.
e with 34% of patients undergoing PCI and 9% undergoing CABG.
t tal- grupp enoxaparin.
The mean treatment duration was ng 5.5 days in the fondaparinux group and 5.2 days in the enoxaparin group.
Meta jkun sar PCI, il- pazjenti jkunu ħadu fondaparinux minn ġol- vini (pazjenti
If PCI was performed, patients received either intravenous fondaparinux (fondaparinux patients) or weight adjusted intravenous UFH (enoxaparin patients) as adjunctive therapy, dependent on the timing of the last lo subcutaneous dose and planned use of GP IIb/ IIIa inhibitor.
za tal- fondaparinux) jew UFH minn ġol- vini b’ aġġustament skond il- piż (pazjenti ta ’ l- enoxaparin) bħala terapija addizzjonali, skond il- ħin ta ’ l- aħħar doża taħt il- ġilda u l- użu ppjanat ta ’ l- impeditur GP
Approximately 40% and 17% of patients had no
L- eta ’ medja tal- pazjenti kienet ta ’ 67 sena, u madwar 60% kellhom mill- inqas 65 sena.
mild (creatinine clearance ≥ 50 to < 80 ml/ min) or moderate (creatinine clearance ≥ 30 to < 50 ml/ min) renal impairment, respectively.
Madwar 40% u 17% tal- pazjenti kellhom indeboliment ħafif tal- kliewi (tneħħija ta ’ kreatinina ≥50 sa < 80 ml/ min) jew indeboliment moderat (tneħħija ta ’ kreatinina ≥30 sa < 50 ml/ min), rispettivament.
The primary adjudicated endpoint was a composite of death, myocardial infarction (MI) and refractory ct
to L- aħħar riżultat konklussiv tal- proċess aġġudikat u primarju kien kompost ta ’ mewt, infart
ischaemia (RI) within 9 days of randomisation.
aw mijokardijaku (MI) u iskemija rifrattarja (RI) fi żmien disgħat ijiem mill- għażla magħmula bla pjan.
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, du
Mill- pazjenti tal- grupp fondaparinux, 5. 8% esperjenzaw xi okkorrenza mad- 9 jum meta mqabbla ma ’ 5. 7% tal- pazjenti fuq trattament b’ enoxaparin (hazard ratio 1. 01, 95% CI, 0. 90, 1. 13, valur p mhux inferjuri ta ’ naħa waħda =0. 003).
95% CI, 0.90, 1.13, one-sided non-inferiority p value = 0.003). ro
x du Mal- Jum 30, l- inċidenza ta ’ l- imwiet mill- kawżi kollha tnaqqset sinifikament minn 3. 5% fuq enoxaparin għal 2. 9% fuq fondaparinux (hazard ratio 0. 83, 95% CI, 0. 71; 0. 97, p = 0. 02).
The effects on the incidence of lP
L- effetti fuq l- inċidenza ta ’ MI u RI ma kienux statistikament differenti bejn il- grupp ta ’ trattament ħa b’ fondaparinux u dak b’ enoxaparin. ’ g Fid - 9 jum l- inċidenza ta ’ ħruġ qawwi ta ’ demm fil- każ ta ’ fondaparinux u fil- każ ta ’ enoxaparin kienet ta ’ 2. 1% u 4. 1% rispettivament (hazard ratio 0. 52, 95% CI, 0. 44; 0. 61, p < 0. 001). im
MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.
Ir- riżultati dwar l- effikaċja u dawk fuq il- ħruġ qawwi ta ’ demm kienu konsistenti fis- sottogruppi kollha speċifikati minn qabel, bħall- anzjani, pazjenti b’ indeboliment tal- kliewi, tip ta ’ impedituri ta ’ l - aggregazzjoni tal- plejtlets li ntużaw flimkien (aspirina, thienopyridines jew impedituri ta ’ GP IIb/ IIIa). li l
At Day 9 the incidence of major bleeding on fondaparinux and enoxaparin was 2.1% and 4.1%, na
Fis- sottogrupp ta ’ pazjenti fuq trattament b’ fondaparinux jew enoxaparin li jkunu għamlu PCI, 8. 8% u na
respectively (hazard ratio 0.52, 95% CI, 0.44; 0.61, p < 0.001).
8. 2% ta ’ pazjenti rispettivament, esperjenzaw mewt/ MI/ RI fi żmien 9 t’ jiem mill- għażla li tkun saret bla pjan (hazard ratio 1. 08, 95% CI, 0. 92; 1. 27).
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 M
F’ dan is- sottogrupp, l- inċidenza ta ’ ħruġ qawwi ta ’ demm fil- każ ta ’ fondaparinux u enoxaparin fid - 9 jum kienet ta ’ 2. 2% u 5% rispettivament (hazard iċi
1.08, 95% CI, 0.92; 1.27).
ratio 0. 43, 95% CI, 0. 33; 0. 57). ed
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.
Trattament ta ’ infart mijokardijaku b’ elevazzjoni tas- segment ST (STEMI) OASIS 6 kien studju double blind, mhux bażat fuq xi għażla ppjanata, li jassessja s- sigurta ’ u l - effikaċja ta ’ 2. 5 mg fondaparinux kuljum, kontra kura normali (plaċebo 47% jew UFH( 53%)) tm
All patients received standard treatments for STEMI, including primary PCI (31%), thrombolytics (45%) or no reperfusion (24%).
Il- pazjenti kollha ħadu trattamenti normali għal STEMI, inklużi PCI primarja (31%), sustanzi trombolitiċi (45%) jew ebda reperfużjoni (24%).
Of the patients treated with a thrombolytic, 84% were
Mill- pazjenti trattati b’ sustanza trombolitika, 84% ħadu trattament b’ aġent mhux speċifiku għal- fibrin (primarjament ot
19 treated with a non-fibrin specific agent (primarily streptokinase).
streptokinase).
The mean treatment duration was 6.2 days on fondaparinux.
It- tul medju tat- trattament kien ta ’ 6. 2 jiem fuq fondaparinux.
The mean age of the patients was 61 years, and approximately 40% were at least 65 years old.
L- eta ’ medja tal - pazjenti kienet ta ’ 61 sena, u madwar 40% kellhom għall- inqas 65 sena.
Approximately 40% and 14% of patients had mild (creatinine clearance ≥ 50 to < 80 ml/ min) or moderate (creatinine clearance ≥ 30 to < 50 ml/ min) renal impairment, respectively.
Pr
The primary adjudicated endpoint was a composite of death and recurrent MI (re-MI) within 30 days of randomisation.
L- aħħar riżultat konklussiv tal- proċess aġġudikat u primarju kien kompost ta ’ mewt u MI( re- MI) rikorrenti fi żmien 30 jum mill- għażla magħmula bla pjan.
The incidence of death/ re-MI at Day 30 was significantly reduced from 11.1% for the control group to 9.7% for the fondaparinux group (hazard ratio 0.86, 95% CI, 0.77, 0.96, p = 0.008).
L- inċidenza ta ’ l- imwiet/ re- MI fit - 30 jum tnaqqset sinifikament minn 11. 1% fil- grupp ta ’ kontroll għal 9. 7% fil- grupp fondaparinux (hazard ratio 0. 86, 95% CI, 0. 77, 0. 96, p = 0. 008).