qanastek/EMEA-V3 huggingface dataset:
If a patient is to undergo percutaneous coronary intervention (PCI), unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient’ s potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
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 potenzjali ta ’ 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 ’ 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 tneħħiet ix- sheath.
Treatment of ST segment elevation myocardial infarction (STEMI) The recommended dose of fondaparinux is 2.5 mg once daily.
Trattament ta ’ infart mijokardijaku b’ elevazzjoni tas- segment ST (STEMI) Id- doża rakkomandata ta ’ fondaparinux hi ta ’ 2. 5 mg darba kuljum.
The first dose of fondaparinux is administered intravenously and subsequent doses are administered by subcutaneous injection.
L- ewwel doża ta ’ fondaparinux għandha tingħata ġol- vina u d- dożi ta ’ wara jingħataw b’ injezzjoni subkutanja.
Treatment should be initiated as soon as possible following diagnosis and continued for up to a maximum of 8 days or until hospital discharge if that occurs earlier.
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.
If a patient is to undergo non-primary PCI, unfractionated heparin (UFH) as per local practice should be administered during PCI, taking into account the patient’ s potential risk of bleeding, including the time since the last dose of fondaparinux (see section 4.4).
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 ’ 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 ’ Arixtra wara li titneħħa x- sheath għandu jiġi stabbilit skond il- ġudizzju kliniku.
In the pivotal STEMI clinical trial, treatment with fondaparinux was restarted no earlier than 3 hours after sheath removal.
Fil- prova klinika pivotali STEMI, trattament b’ fondaparinux reġa ’ nbeda mhux aktar kmieni minn 3 sigħat wara li tneħħiet ix- sheath.
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 restarted 48 hours post-operatively.
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.
Prevention of VTE following Surgery In patients undergoing surgery, timing of the first fondaparinux injection requires strict adherence in patients ≥ 75 years, and/ or with body weight < 50 kg and/ or with renal impairment with creatinine clearance ranging between 20 to 50 ml/ min.
Prevenzjoni ta ’ VTE wara l- kirurġija Għall- ewwel injezzjoni b’ fondaparinux hu importanti li jkun hemm aderenza stretta mal- ħin f’ pazjenti li jgħaddu minn kirurġija, li għandhom ≥ 75 sena, u/ jew b’ piż tal- ġisem < 50 kg u/ jew indeboliment renali bi clearance tal- krejatinina ta ’ bejn 20 u 50 ml/ min.
Renal impairment • Prophylaxis of VTE - Fondaparinux should not be used in patients with creatinine clearance < 20 ml/ min (see section 4.3).
14 Indeboliment renali • Profilassi ta ’ VTE - Fondaparinux m’ għandux jingħata lil pazjenti bi clearance tal- krejatinina < 20 ml/ min (ara sezzjoni 4. 3).
The dose should be reduced to 1.5 mg once daily in patients with creatinine clearance in the range of 20 to 50 ml/ min (see sections 4.4 and 5.2).
F’ pazjenti bi clearance tal- krejatinina ta ’ bejn 20 sa 50 ml/ min, id- doża ta ’ fondaparinux għandha titnaqqas għal 1. 5 mg darba kuljum (ara sezzjonijiet 4. 4 u 5. 2).
No dosage reduction is required for patients with mild renal impairment (creatinine clearance > 50 ml/ min).
M’ hemmx bżonn li titnaqqas id- doża f’ pazjenti b’ indeboliment renali ħafif (clearance tal - krejatinina > 50 ml/ min).
13 Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
Indeboliment tal- fwied - Ma hemm bżonn ta ’ l- ebda aġġustament fid- doża f’ pazjenti b’ indeboliment tal- fwied ħafif jew moderat.
Method of administration • Subcutaneous administration Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
Metodu ta ’ amministrazzjoni • Amministrazzjoni subkutanja Fondaparinux huwa amministrat permezz ta ’ injezzjoni subkutanja fonda waqt li l- pazjent ikun mindud.
To avoid the loss of medicinal product when using the pre- filled syringe do not expel the air bubble from the syringe before the injection.
Biex tevita telf tal - prodott mediċinali waqt l- użu ta ’ l- injezzjoni mimlija lesta m’ għandekx tespella l- buzzieqa ta ’ l - arja minn ġos- siringa qabel l- injezzjoni.
• Intravenous administration (first dose in patients with STEMI only) Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
• Amministrazzjoni ġol- vina (l- ewwel doża f’ pazjenti bi STEMI biss) L- amministrazzjoni ġol- vina għandha tkun minn ġo linja intravenuża diġa` esistenti direttament jew permezz ta ’ volum żgħir (25 jew 50ml) ta ’ saline 0. 9% f’ borża żgħira.
To avoid the loss of medicinal product when using the pre-filled syringe do not expel the air bubble from the syringe before the injection.
Biex tevita telf tal - prodott mediċinali waqt l- użu ta ’ l- injezzjoni mimlija lesta m’ għandekx tespella l- buzzieqa ta ’ l - arja minn ġos- siringa qabel l- injezzjoni.
The intravenous tubing should be well flushed with saline after injection to ensure that all of the medicinal product is administered.
It- tubi li jgħaddu għal ġol- vina għandhom jitlaħalħu sew bis- saline wara l- injezzjoni biex t’ assigura li l- prodott mediċinali jingħata kollu.
If administered via a minibag, the infusion should be given over 1 to 2 minutes.
Jekk jingħata permezz ta ’ borża żgħira, l- infusjoni għandha tingħata fuq minuta għal 2 minuti.
Fondaparinux must not be administered intramuscularly.
Fondaparinux m’ għandux jiġi amministrat b’ mod intramuskolari.
For prevention of VTE, agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
15 Fil- prevenzjoni ta ’ VTE, aġenti li jistgħu jżidu r- riskju ta ’ emorraġija m’ għandhomx jiġu amministrati flimkien ma ’ fondaparinux.
When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of section 4.5.
Meta jkun hemm bżonn terapija konkomitanti ma ’ antagonist tal- vitamina K għandha tiġi amministrata skond l - informazzjoni mogħtija f’ sezzjoni 4. 5.
14 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.
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 qabel u wara l- PCI.
These are patients with refractory or recurrent angina associated with dynamic ST deviation, heart failure, life- threatening arrhythmias or haemodynamic instability.
Dawn huma pazjenti li qegħdin ibatu minn anġina rikurrenti jew rifrattorja assoċjata ma ’ devjazzjoni 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).
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).
There are limited data on the use of UFH during non-primary PCI in patients treated with fondaparinux (see section 5.1).
Hemm tagħrif limitat dwar l- użu ta ’ UFH waqt PCI mhux primarju f’ pazjenti li qed jirċievu trattament b ’ fondaparinux (ara sezzjoni 5. 1).
In those patients who underwent non-primary PCI 6-24 hours after the last dose of fondaparinux, the median dose of UFH was 8,000 IU and the incidence of major bleeding was 2% (2/ 98).
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 ’ 8, 000 IU u l- inċidenza ta ’ 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 5,000 IU and the incidence of major bleeding was 4.1% (2/ 49).
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 ’ 5, 000 IU u l- inċidenza ta ’ fsada maġġuri kienet ta ’ 4. 1% (2/ 49).
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 1.2% vs 0% (fondaparinux vs. control).
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 0% (fondaparinux kontra l- kontroll).
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 spinal/ epidural anaesthesia or spinal puncture.
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 ’ Arixtra u anesteżija spinali jew epidurali jew titqib spinali.
Renal impairment Fondaparinux is known to be mainly excreted by the kidney.
16 Indeboliment renali Fondaparinux hu magħruf li jiġi mneħħi prinċipalment mill- kliewi.
• Treatment of UA/ NSTEMI and STEMI - For the treatment of UA/ NSTEMI and STEMI, there are limited clinical data available on the use of fondaparinux 2.5mg once daily in patients with creatinine clearance between 20 and 30 ml/ min.
• 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.
Therefore the physician should determine if the benefit of treatment outweighs the risk (see sections 4.2 and 4.3).
Għalhekk it- tabib għandu jara jekk il- benefiċju tat- trattament huwa akbar mir- riskju (ara sezzjonijiet 4. 2 u 4. 3).
15 Patients with Heparin Induced Thrombocytopenia Fondaparinux should be used with caution in patients with a history of HIT.
Pazjenti bi tromboċitopenja indotta bl- Eparina Fondaparinux għandu jintuża b’ kawtela f’ pazjenti li kellhom TIE fil- passat.
Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Fondaparinux lanqas ma influwenzat l- attivita` INR ta ’ warfarin, lanqas il- ħin ta ’ fsada taħt acetylsalicylic acid jew trattament ta ’ piroxicam, lanqas il - farmakokinetiċi ta ’ digoxin fi stat fiss.
4.7 Effects on ability to drive and use machines
17 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
The safety of fondaparinux 2.5 mg has been evaluated in:
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
- 3, 595 pazjent għaddejjin minn kirurġija ortopedika maġġuri fir- riġlejn li ġew trattati għal mhux
of 1 week
ġimgħat wara profilassi inizjali ta ’ ġimgħa
- 1,407 patients undergoing abdominal surgery treated up to 9 days
- 1, 407 pazjent għaddejjin minn kirurġija ta ’ l- addomenu li ġew trattati mhux iżjed minn 9 t’ ijiem
16 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.
Fil- prevenzjoni ta ’ VTE, l- effetti mhux mixtieqa li ġew irrappurtati mill- investigatur bħala dawk li ta ’ l- inqas għandhom possibilment x’ jaqsmu ma ’ fondaparinux huma rranġati f’ kull grupp ta ’ frekwenza (komuni ħafna: ≥ 1/ 10; komuni: ≥1/ 100 sa < 1/ 10; mhux komuni: ≥ 1/ 1, 000 sa < 1/ 100; 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
18 Sistema tal- klassifika tal- organi fid- database MedDRA
Common: post-operative haemorrhage, anaemia
Rari: infezzjonijiet tal- feriti wara Infezzjonijiet u l- operazzjoni Infestazzjonijiet
Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Komuni: fsada (ematoma, Disturbi tad- demm u tas - Komuni: emorraġija wara ematurja, emoptisis, fsada tal - operazzjoni, anemija sistema limfatika ħanek) Mhux komuni: telf ta ’ demm Mhux komuni: anemija (epistaxis, emoptisis gastro - intestinali, ematurja, ematoma) thromboċitopenja, purpura, thrombocitemja, plejtlet abnormali, mard tal - koagulazzjoni
haemoptysis, gingival bleeding) Uncommon: anaemia
Rari: reazzjonijiet allerġiċi Distubi fis- sistema immuni
Immune system disorders Rare: allergic reaction
Disturbi fil- metaboliżmu Rari:
Metabolism and nutrition Rare: hypokalaemia disorders
Ipokalimja u n- nutrizzjoni
Nervous system disorders Rare: anxiety, somnolence, vertigo, dizziness, headache, confusion
Rari: anzjeta`, nagħas, vertigo, Disturbi fis- sistema sturdament, uġigħ ta ’ ras, nervuża konfużjoni
Vascular disorders
Rari: pressjoni tad- demm baxxa Disturbi vaskulari Disturbi respiratorji, toraċiċi u medjastinali
Respiratory, thoracic and mediastinal disorders
Rari: qtugħ ta ’ nifs, sogħla
Rare: dyspnoea, coughing
Mhux komuni: qtugħ ta ’ nifs
Uncommon: nausea, vomiting Rare: abdominal pain, dyspepsia, gastritis, constipation, diarrhoea
Mhux komuni: dardir, rimettar Rari: uġigħ ta ’ l- addomenu, indiġestjoni, gastrite, stitikezza, dijareja
17 Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda
Uncommon: oedema, oedema peripheral, fever, wound secretion Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital, flushing, syncope
19 Mhux komuni: uġigħ fis- sider Mhux komuni: edema, edema Disturbi ġenerali u periferali, deni, nixxija mill- ferita kundizzjonijiet ta ’ mnejn Rari: uġigħ fis- sider, għejja, jingħata fwawar bi sħana, uġigħ fir - riġlejn, edema ġenitali, fwawar, sinkope
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.
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.
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.
1.4% (control [UFH/ placebo]) up to and including Day 9 in the Phase III STEMI study.
Fl- istudju 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 ’ 1. 1% (fondaparinux) kontra 1. 4% (kontroll [UFH/ plaċebo]) sa d - 9 ġurnata, din inkluża.
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.
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.
In the Phase III study in STEMI patients, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were atrial fibrillation, pyrexia, chest pain, headache, ventricular tachycardia, vomiting, and hypotension.
Fil- pazjenti ta ’ l- istudju fi Fasi III STEMI, 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 fibrillazzjoni ta ’ l- atriju, deni, uġigħ fis- sider, uġigħ ta ’ ras, takikardija ventrikulari, remettar u pressjoni baxxa.
There is no known antidote to fondaparinux.
M’ hemmx antidotu għal fondaparinux
18 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.
20 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 (PT) / International Normalised Ratio (INR), testijiet fil- ħin tal- plażma jew fsada jew attivita` fibronolitika.
Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days The fondaparinux clinical program was designed to demonstrate the efficacy of fondaparinux for the prevention of venous thromboembolic events (VTE), i. e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
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 - 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 t’ isfel tal- ġisem bħal frattura fil- ġenb, kirurġija maġġuri fl- irkoppa jew kirurġija għal sostituzzjoni tal - ġenb.
Over 8,000 patients (hip 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 started 12-24 hours after surgery.
Fondaparinux 2. 5 mg 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.
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.
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.
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 In a double-blind clinical study, 2,927 patients were randomized to receive fondaparinux 2.5mg once daily or dalteparin 5,000 IU once daily, with one 2,500 IU preoperative injection and a first 2,500 IU post-operative injection, for 7+2 days.
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 li jgħaddu minn kirurġija ta ’ kanċer ta ’ l- addomenu Fi studju kliniku double- blind, 2, 927 pazjent kienu mgħotija, mingħajr ma ġew magħżula, fondaparinux 2. 5 mg darba kuljum jew dalteparin 5, 000 IU darba kuljum, b ’ injezzjoni waħda qabel l - operazzjoni ta ’ 2, 500 IU u l- ewwel injezzjoni ta ’ 2, 500 IU wara l- operazzjoni, għal 7 ± 2 ġranet.
(62/ 1,021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
21 F’ dan l- istudju, l- inċidenza ta ’ VTE totali b ’ fondaparinux kien ta ’ 4. 6% (47/ 1, 027), meta mqabbel ma ’ 6. 1% (62/ 1, 021) b ’ dalteparin: reduzzjoni ta ’ l - odds ratio [95% CI] = - 25. 8% [- 49. 7%, 9. 5%].
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.
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 class III/ IV and/ or acute respiratory illness and/ or acute infectious or inflammatory disease.
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 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%) vs 34 patients (10.5%), respectively].
Fondaparinux naqqas sinifikament ir- rata sħiha ta ’ VTE meta mqabbel ma ’ l- plaċebo [18 - il pazjent (5. 6%) vs 34 pazjenti (10. 5%), rispettivament].
Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/ NSTEMI) OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2.5 mg subcutaneously once daily versus enoxaparin 1 mg/ kg subcutaneously twice daily in approximately 20,000 patients with UA/ NSTEMI.
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, with 34% of patients undergoing PCI and 9% undergoing CABG.
Il- pazjenti kollha ġew mogħtija trattament mediku normali għal UA/ NSTEMI, bi 34% minnhom operati b’ PCI u 9% minnhom b’ CABG.
The mean treatment duration was 5.5 days in the fondaparinux group and 5.2 days in the enoxaparin group.
It- tul medju ta ’ trattament kien 5. 5 jiem fil- każ tal- grupp fondaparinux u 5. 2 jiem fil- każ tal- grupp enoxaparin.
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 subcutaneous dose and planned use of GP IIb/ IIIa inhibitor.
Meta jkun sar PCI, il- pazjenti jkunu ħadu fondaparinux minn ġol- vini (pazjenti 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 IIb/ IIIa.
The mean age of the patients was 67 years, and approximately 60% were at least 65 years old.
L- eta ’ medja tal- pazjenti kienet ta ’ 67 sena, u madwar 60% kellhom mill- inqas 65 sena.
Approximately 40% and 17% of patients had 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 ischaemia (RI) within 9 days of randomisation.
L- aħħar riżultat konklussiv tal- proċess aġġudikat u primarju kien kompost ta ’ mewt, infart 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, 95% CI, 0.90, 1.13, one-sided non-inferiority p value = 0.003).
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).
By Day 30, the incidence of all cause mortality was significantly reduced from 3.5% on enoxaparin to 2.9% on fondaparinux (hazard ratio 0.83, 95% CI, 0.71; 0.97, p = 0.02).
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 MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.
L- effetti fuq l- inċidenza ta ’ MI u RI ma kienux statistikament differenti bejn il- grupp ta ’ trattament b’ fondaparinux u dak b’ enoxaparin.
At Day 9 the incidence of major bleeding on fondaparinux and enoxaparin was 2.1% and 4.1%, respectively (hazard ratio 0.52, 95% CI, 0.44; 0.61, p < 0.001).
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).
The efficacy findings and results on major bleeding were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines or GP IIb/ IIIa inhibitors).
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).
In the subgroup of patients treated with fondaparinux or enoxaparin who underwent PCI, 8.8% and 8.2% of patients respectively, experience death/ MI/ RI within 9 days of randomisation (hazard ratio 1.08, 95% CI, 0.92; 1.27).
22 Fis- sottogrupp ta ’ pazjenti fuq trattament b’ fondaparinux jew enoxaparin li jkunu għamlu PCI, 8. 8% u 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 this subgroup, the incidence of major bleeding on fondaparinux and enoxaparin at Day 9 was 2.2% and 5.0% respectively (hazard ratio 0.43, 95% CI, 0.33; 0.57).
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 ratio 0. 43, 95% CI, 0. 33; 0. 57).
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 12,000 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- sigurtà u l - effikaċja ta ’ 2. 5 mg fondaparinux kuljum, kontra kura normali (plaċebo 47% jew UFH( 53%)) f’ madwar 12000 pazjent bi STEMI.
All patients received standard treatments for STEMI, including primary PCI (31%),
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 treated with a non-fibrin specific agent (primarily streptokinase).
Mill- pazjenti trattati b’ sustanza trombolitika, 84% ħadu trattament b’ aġent mhux speċifiku għal- fibrin (primarjament streptokinase).
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.
Madwar 40% u 14% tal - pazjenti kellhom, rispettivament, indeboliment ħafif tal- kliewi (tneħħija ta ’ kreatinina ≥50 sa < 80 ml/ min) jew indeboliment moderat (tneħħija ta ’ kreatinina ≥30 sa < 50 ml/ min).
In the predefined stratum comparing fondaparinux to placebo (i. e patients treated with non- fibrin specific lytics (77.3%), no reperfusion (22%), fibrin-specific lytics (0.3%), primary PCI (0.4%), the incidence of death/ re-MI at Day 30 was significantly reduced from 14.0% on placebo to 11.3% (hazard ratio 0.80, 95% CI, 0.69, 0.93, p = 0.003).
Fl- istratum definit minn qabel li qabbel fondaparinux ma 'plaċebo (i. e. pazjenti trattati b' sustanzi litiċi mhux speċifiċi għal- fibrin (77. 3%), ebda reperfużjoni (22%), sustanzi litiċi speċifiċi għal- fibrin (0. 3%), PCI primarja (0. 4%), l- inċidenza ta ’ mewt/ re- MI fit - 30 jum tnaqqset sinifikament minn 14. 0% fuq plaċebo għal 11. 3% (hazard ratio 0. 80, 95% CI, 0. 69.
In the predefined stratum comparing fondaparinux to UFH (patients treated with primary PCI (58.5%), fibrin-specific lytics (13%), non-fibrin-specific lytics (2.6%) and no reperfusion (25.9%), the effects of fondaparinux and UFH on the incidence of death/ re-MI at Day 30 were not statistically different: respectively, 8.3% vs 8.7% (hazard ratio 0.94, 95% CI, 0.79, 1.11 p = 0.460).
Fl- istratum definit minn qabel li kkumpara fondaparinux ma ’ UFH (pazjenti trattati b’ PCI primarja (58. 5%), sustanzi litiċi speċifiċi għal- fibrin (13%), sustanzi litiċi li mhumiex speċifiċi għal- fibrin (2. 6%) u ebda reperfużjoni (25. 9%), l- effetti ta ’ fondaparinux u UFH fuq l- inċidenza ta ’ mewt/ re- MI f’ Jum 30 ma kienux statistikament differenti: rispettivament, 8. 3% vs 8. 7% (hazard ratio 0. 94, 95% CI, 0. 79, 1. 11 p = 0. 460).
However, in this stratum, in the subgroup of indicated population undergoing thrombolysis or no reperfusion (i. e patients not undergoing primary PCI), the incidence of death/ re-MI at Day 30 was significantly reduced from 14.3% on UFH to 11.5% with fondaparinux (hazard ratio 0.79, 95% CI, 0.64, 0.98, p = 0.03).
Madankollu, f’ dan l- istratum, fis- sottogrupp tal- popolazzjoni indikata li kienu qegħdin jirċievu trombolitiċi jew ebda reperfużjoni (i. e. pazjenti li mhumiex qegħdin jgħaddu minn PCI primarja), l- inċidenza ta ’ mewt/ re- MI fit- 30 jum tnaqqset sinifikament minn 14. 3% fuq UFH għal 11. 5% b’ fondaparinux (hazard ratio 0. 79, 95% CI, 0. 64, 0. 98, p = 0. 03).
The incidence of all cause mortality at Day 30 was also significantly reduced from 8.9% for the control group to 7.8% in the fondaparinux group (hazard ratio 0.87, 95% CI, 0.77; 0.98, p = 0.02).
L- inċidenza tal- mortalita ’ mill- kawżi kollha fit- 30 jum tnaqqset ukoll sinifikament minn 8. 9% fil - grupp ta ’ kontroll għal 7. 8% fil- grupp fondaparinux (hazard ratio 0. 87, 95% CI, 0. 77; 0. 98, p = 0. 02).
The difference in mortality was statistically significant in stratum 1 (placebo comparator) but not in stratum 2 (UFH comparator).
Id- differenza fil- mortalità kienet statistikament sinifikanti f’ stratum 1 (komparatur plaċebo) imma mhux f’ stratum 2 (komparatur UFH).
The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180.
Il- benefiċċji ta ’ mortalita ’ li ntwera fil grupp fondaparinux baqgħet hekk sa l- aħħar ta ’ l- insegwiment fil- 180 jum.
In patients who were revascularised with a thrombolytic, fondaparinux significantly reduced the incidence of death/ re-MI at Day 30 from 13.6% for the control group to 10.9% (hazard ratio 0.79, 95%CI, 0.68; 0.93, p = 0.003).
F’ pazjenti li kienu rivaskularizzati b’ sustanza trombolitika, fondaparinux naqqas l- inċidenza ta ’ mewt/ re- MI b’ mod sinifikanti fit- 30 jum minn 13. 6% fil- grupp ta ’ kontroll għal 10. 9% (hazard ratio 0. 79, 95% CI, 0. 68; 0. 93, p = 0. 003).
Among patients initially not reperfused, the incidence of death/ re-MI at Day 30 was significantly reduced from 15% for the control group to 12.1% for the fondaparinux group (hazard ratio 0.79, 95% CI, 0.65; 0.97, p = 0.023).
Fost il- pazjenti li għall- bidu ma kienux riperfużi, l- inċidenza ta ’ mewt/ re- MI tnaqqset b’ mod sinifikanti fit- 30 jum minn 15% fil- grupp ta ’ kontroll għal 12. 1% fil - grupp fondaparinux (hazard ratio 0. 79, 95% CI, 0. 65; 0. 97, p = 0. 023).
In patients treated with primary PCI, the incidence of death/ re-MI at Day 30 was not statistically different between the two groups [6.0% in fondaparinux group vs 4.8% in the control group; hazard ratio 1.26, 95% CI, 0.96, 1.66].
F’ pazjenti trattati b’ PCI primarja l- inċidenza ta ’ mewt/ re- MI fit- 30 jum ma kienitx statistikament differenti bejn iż- żewġ gruppi (6. 0% fil- grupp fondaparinux kontra 4. 8% fil- grupp ta ’ kontroll; hazard ratio 1. 26, 95% CI, 0. 96, 1. 66).
By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
Mad- 9 jum, 1. 1% ta ’ pazjenti trattati b’ fondaparinux u 1. 4% tal- pazjenti taħt kontroll esperjenzaw emorraġija qawwija.
In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the fondaparinux patients and in 2.0% of controls.
F’ pazjenti li ħadu sustanza trombolitika, emorraġija qawwija seħħet f’ 1. 3% tal - pazjenti b’ fondaparinux u f’ 2. 0% f’ pazjenti taħt kontroll.
In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
F’ pazjenti li għall- bidu ma kienux riperfużi, l- inċidenza ta ’ emorraġija qawwija kienet ta ’ 1. 2% f’ dawk fuq fondaparinux kontra 1. 5% f’ dawk taħt kontroll.
For patients receiving primary PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
F’ pazjenti li kienu fuq PCI primarja, l- inċidenza ta ’ emorraġija qawwija kienet ta ’ 1. 0% f’ dawk fuq fondaparinux u 0. 4% f’ dawk taħt kontroll.
The efficacy findings and results on severe haemorrhage were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines).
23 Dak li nstab dwar effikaċja u r- riżultati dwar emorraġija qawwija kienu konsistenti fis- sottogruppi speċifikati minn qabel, bħall- anzjani, pazjenti b’ indeboliment tal- kliewi, t- tip ta ’ impedituri konkomitanti kontra l- aggregazzjoni tal- plejtlets (aspirina, thienopyridines).
Following once daily subcutaneous dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC.
B’ dożaġġ ta ’ darba kuljum, livelli stabbli fil- plażma huma miksuba wara 3 sa 4 t’ ijiem b’ żieda ta ’ 1. 3- il darba fis- Cmax u AUC.
21 Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are:
Stimi tal- parametri farmakokinetiċi medji fissi (CV%) ta ’ fondaparinux f’ pazjenti għaddejjin minn kirurġija għal sostituzzjoni tal- ġenb u li qed jirċievu Arixtra 2. 5 mg darba kuljum huma:
Renal impairment - Compared with patients with normal renal function (creatinine clearance > 80 ml/ min), plasma clearance is 1.2 to 1.4 times lower in patients with mild renal impairment (creatinine clearance 50 to 80 ml/ min) and on average 2 times lower in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/ min).
24 Indeboliment renali - Pparagunati ma ’ pazjenti b’ funzjoni renali normali (clearance tal- krejatinina > 80 ml/ min), il- clearance tal- plażma hija minn 1. 2 sa 1. 4 drabi iktar baxxa f’ pazjenti b’ indeboliment renali ħafif (clearance tal- krejatinina minn 50 sa 80 ml/ min) u fuq medja ta ’ darbtejn iktar baxxa f’ pazjenti b’ indeboliment renali moderat (clearance tal- krejatinina minn 30 sa 50 ml/ min).
Gender - No gender differences were observed after adjustment for body weight.
Sess - Ma ġew osservati l- ebda differenzi minħabba s- sess wara li sar aġġustament tal- piż tal- ġisem.
The lower plasma concentrations of fondaparinux were attributed to reduced binding to ATIII secondary to the lower ATIII plasma concentrations in subjects with hepatic impairment thereby
Il- konċentrazzjonijiet aktar baxxi ta ’ fondaparinux fil- plażma ġew attribwiti ma ’ l- irbit mnaqqas ma ’ ATIII minħabba konċentrazzjoni fil- plażma aktar baxxa ta ’ ATIII f’ suġġetti b’ indeboliment tal- fwied u dan iwassal għal żjieda fit- tneħħija ta ’ fondaparinux mill- kliewi.
If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours.
Jekk fondaparinux sodium jiġi miżjud ma ’ saline 0. 9% f’ borża żgħira, għandu idejalment jingħata permezz ta ’ infużjoni immedjatament, imma jista ’ jinħażen f’ temperatura ambjentali sa 24 siegħa.
There are two types of syringes: • syringe with a blue plunger and an automatic safety system • syringe with blue plunger and a manual safety system.
siringa bi planġer blu u b’ sistema ta ’ sikurezza awtomatika. siringa bi planġer blu u b’ sistema manwali ta ’ sigurtà.
Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
L- amministrazzjoni ġol - vina għandha ssir minn ġo linja intravenuża diġà eżistenti, direttament jew permezz ta ’ volum żgħir (25 ml jew 50 ml) ta ’ 0. 9% saline f’ borża żgħira.
23 Instruction on self-administration by subcutaneous injection is included in the Package Leaflet.
Struzzjonijiet għal amministrazzjoni personali permezz ta ’ injezzjoni sub- kutanja huma inklużi fil - fuljett ta ’ tagħrif.
24 1.
27 1.
Arixtra 5 mg/ 0.4 ml solution for injection, pre-filled syringe.
Arixtra 5 mg/ 0. 4 ml soluzzjoni għall- injezzjoni, siringa mimlija lesta
Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.
It- trattament ta ’ Trombożi akuta f’ Vina Fonda (DVT) u t- trattament ta ’ Emboliżmu Pulmonari (PE) akut, ħlief f’ pazjenti li huma emodinamikament instabli jew f’ pazjenti li għandhom bżonn tromboliżi jew embolektomija.
The recommended dose of fondaparinux is 7.5 mg (patients with body weight ≥ 50, ≤ 100kg) once daily administered by subcutaneous injection.
Id- doża rakkomandata ta ’ fondaparinux hija ta ’ 7. 5 mg (f ’ pazjenti b’ piż ta ’ ≥ 50, ≥ 100 kg) darba kuljum li tingħata b’ injezzjoni subkutanja.
For patients with body weight < 50 kg, the recommended dose is 5 mg.
Għal pazjenti b’ piż ta ’ < 50 kg, id- doża rakkomandata hija ta ’ 5 mg.
For patients with body weight > 100 kg, the recommended dose is 10 mg.
Għal pazjenti b’ piż ta ’ > 100 kg, id- doża rakkomandata hija ta ’ 10 mg.
Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3).
It- trattament għandu jitkompla għal mill- inqas 5 t’ ijiem u sakemm antikoagulazzjoni adekwata b’ antikoagulant orali tkun stabbilita b’ mediċina orali (International Normalised Ratio 2 sa 3).
Concomitant oral anticoagulation treatment should be initiated as soon as possible and usually within 72 hours.
Trattament fl’ istess ħin b ’ antikoagulant orali għandu jinbeda malajr kemm jista ’ jkun u s- soltu fi żmien 72 siegħa.
The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited.
Il- tul medju tat- trattament fi studji kliniċi kien ta ’ 7 t ’ ijiem u l- esperjenza klinika mit- trattament għal aktar minn 10 t’ ijiem hija limitata.
In patients ≥ 75 years, fondaparinux should be used with care, as renal function decreases with age (see section 4.4).
Għandha tittieħed attenzjoni bl- użu ta ’ fondaparinux f’ pazjenti ≥ 75 sena għaliex il- funzjoni renali tonqos bl- eta` (ara sezzjoni 4. 4).
Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Indeboliment tal- kliewi - Għandha tittieħed attenzjoni bl- użu ta ’ fondaparinux f’ pazjenti b’ indeboliment moderat tal- kliewi (ara sezzjoni 4. 4).
In this subgroup, after an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.4).
F’ dan is- sub- grupp, wara doża fil- bidu ta ’ 10 mg kuljum, tista ’ tiġi kunsidrata, meta bażata fuq mudell farmakokinetiku, tnaqqis tad- doża għal 7. 5 mg kuljum (ara sezzjoni 4. 4).
25 Hepatic impairment - No dosing adjustment is necessary in patients with either mild or moderate hepatic impairment.
28 Indeboliment tal- fwied - M’ hemmx bżonn aġġustament tad- doża f’ pazjenti b’ indeboliment tal- fwied ħafif jew moderat.
In patients with severe hepatic impairment, fondaparinux should be used with care as this patient group has not been studied (see sections 4.4 and 5.2).
Għandha tittieħed attenzjoni bl- użu ta ’ fondaparinux f’ pazjenti b’ indeboliment sever tal- fwied għaliex dan il- grupp ta 'pazjenti ma ġiex studjat (ara sezzjonijiet 4. 4 u 5. 2).
Fondaparinux is intended for subcutaneous use only.
Fondaparinux huwa intenzjonat għall- użu subkutanju biss.
Do not administer intramuscularly.
Tinjettax fil- muskoli.
There is limited experience from treatment with fondaparinux in haemodynamically unstable patients and no experience in patients requiring thrombolysis, embolectomy or insertion of a vena cava filter.
Hemm esperjenza limitata mit- trattament b ’ fondaparinux f’ pazjenti li m’ humiex stabbli emodinamikament u m’ hemm l- ebda esperjenza f’ pazjenti li għandhom bżonn tromboliżi, embolektomija jew li jiddaħħal filter ġol- vena cava.
Haemorrhage Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e. g. platelet count < 50,000/ mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below.
Emorraġija Fondaparinux għandu jintuża b’ attenzjoni f’ pazjenti b’ riskju ogħla ta ’ emorraġija, bħal dawk b’ mard ta 'fsada kemm konġenitali jew akkwistati (es. għadd ta ’ plejtlets < 50, 000 / mm3), mard gastro - intestinali ulċerattiv attiv u emorraġija riċenti fil- kranju jew ftit wara kirurgija fil- moħħ, is- sinsla jew l- għajnejn u fi gruppi speċjali ta ’ pazjenti li jissemmew hawn taħt.
As for other anticoagulants, fondaparinux should be used with caution in patients who have undergone recent surgery (< 3 days) and only once surgical haemostasis has been established.
Bħal kull antikoagulant ieħor, fondaparinux għandu jintuża b’ attenzjoni f’ pazjenti li għaddew minn kirurġija riċenti (< 3 t ’ ijiem) u jintuża biss meta jiġi stabbilit emostasi kirurġiku.
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, antagonisti ta ’ riċetturi GP IIb/ IIIa, heparin, heparinoids, jew Heparin ta ’ Piż Molekulari Baxx (LMWH).
During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
Waqt trattament ta ’ VTE, f’ istess ħin għandha tingħata terapija b’ antagonista ta ’ vitamina K skond l- informazzjoni f ’ Sezzjoni 4. 5.
Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution.
Mediċini oħra kontra l- plejtlets (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine jew clopidogrel), u NSAIDs għandhom jintużaw b’ attenzjoni.
If co- administration is essential, close monitoring is necessary.
Fil- każ li jkun essenzjali li jingħataw flimkien, jkun hemm bżonn ta ’ osservazzjoni mill- qrib.
Spinal / Epidural anaesthesia In patients receiving fondaparinux for treatment of VTE rather than prophylaxis, spinal/ epidural anaesthesia in case of surgical procedures should not be used.
Anestesija Spinali / Epidurali F’ pazjenti li jieħdu fondaparinux għal trattament ta ’ VTE u mhux bħala profilassi, m’ għandiex tintuża anestesija spinali/ epidurali fil- każ ta ’ kirurġija.
As renal function generally decreases with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
Il- funzjoni renali ġeneralment tonqos bl- eta`, u għalhekk pazjenti anzjani jistgħu jkollhom eliminazzjoni mnaqqsa u esponiment akbar ta ’
The
Każi ta ’ fsada f’ pazjenti li kellhom < 65 sena, 65- 75 sena u > 75 sena, li jieħdu d- dożaġġ rakkomandat fit- trattament ta ’ DVT jew PE u kienu ta ’ 3. 0%, 4. 5% and 6. 5%, rispettivament.