FrancophonIA/ELRC3.0 huggingface dataset:
English: Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopaedic surgery.
Maltese: Ma nstabux differenzi filclearance tal-plażma bejn pazjenti suwed u Kawkasi li għamlu kirurġija ortopedika.
English: During treatment of VTE, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
Maltese: VTE, f'istess ħin għandha tingħata terapija b'antagonista ta' vitamina K skond l-informazzjoni f' Sezzjoni 4.5.
English: • swelling (oedema)
Maltese: • tbenġil jew nefħa (edima)
English: Fondaparinux 2.5 mg once daily started 6-8 hours postoperatively was compared with enoxaparin 40 mg once daily started 12 hours before surgery, or 30 mg twice daily started 12-24 hours after surgery.
Maltese: Fondaparinux 2.5 mg darba kuljum mibdi 6-8 sigħat wara l-operazzjoni ġie ipparagunat ma' enoxaparin 40 mg darba kuljum mibdi 12-il siegħa qabel il-kirurġija, jew 30 mg darbtejn kuljum mibdi 12-24 siegħa wara l-kirurġija.
English: Fondaparinux is excreted to 64 - 77 % by the kidney as unchanged compound.
Maltese: Sa 64-77% ta' fondaparinux jitneħħa mill-kliewi f'forma mhux mibdula.
English: Major bleeding during the initial treatment period was observed in 1.1% of fondaparinux patients, compared to 1.2% with enoxaparin.
Maltese: Fsada maġġuri fil-perjodu tal-bidu tat-trattament kienet osservata f' 1.1% tal-pazjenti fuq fondaparinux meta mqabbel ma' 1.2% fil-pazjenti fuq enoxaparin.
English: INFORMATION IN BRAILLE arixtra 5 mg
Maltese: arixtra 5 mg
English: In DVT and PE treatment, patients receiving fondaparinux 5 mg (body weight <50 kg), 7.5 mg (body weight 50-100 kg inclusive) and 10 mg (body weight >100 kg) once daily, the body weight-adjusted doses provide similar exposure across all body weight categories.
Maltese: Fit-trattament ta' DVT u PE, f' pazjenti li jieħdu fondaparinux 5 mg (piż <50 kg), 7.5 mg (piż 50-100 kg inklużi), u 10 mg (piż >100 kg) kuljum, kien hemm esponiment simili f'kull kategorija ta' piż meta d-dożi ta' kuljum kienu aġġustati għall-piż.
English: • 7.5 mg fondaparinux sodium in 0.6 ml solution for injection
Maltese: • 7.5 mg ta' fondaparinux sodium f'0.6 ml ta' soluzzjoni għall-injezzjoni
English: The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.3% (13/559), 4.6% (17/368), 9.7% (14/145) and 11.1% (2/18) respectively, and in patients receiving the recommended regimen of unfractionated heparin in the treatment of PE were 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.7% (3/28), respectively.
Maltese: rispettivament, u l-każi f'pazjenti li jieħdu d-dożaġġ rakkomandat ta' eparina mhux frazzjonata fit trattament ta' PE kienu ta' 6.9% (36/523), 3.1% (11/352), 11.1% (18/162) and 10.
English: Over 100 kg
Maltese: 10 kg).
English: Prevention of Venous Thromboembolic Events (VTE) in medical patients who are at high risk for thromboembolic complications due to restricted mobility during acute illness In a randomised double-blind clinical trial, 839 patients were treated with fondaparinux 2.5 mg once daily or placebo for 6 to 14 days.
Maltese: 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 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.
English: Arixtra syringe contains latex
Maltese: Allerġija għall-lattiċe
English: Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Arixtra.
Maltese: Dawn huma rari ħafna fil-persuni (sa 1 minn kull 10,000) li jieħdu Arixtra.
English: 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.
Maltese: F'sub-grupp kbir ta' pazjenti b'kirurġija għallkanċer (69% mill-pazjenti), ir-rata ta' VTE kienet ta' 4.7% fil-grupp ta' fondaparinux, meta mqabbel ma' 7.7% fil- grupp ta' dalteparin.
English: The study population was 64% female, with a median age of 58 years, 4.4% had a creatinine clearance <50ml/min.
Maltese: Il-popolazzjoni tal-istudju kienet 64% nisa, b'età medjana ta' 58 sena, 4.4% minnhom kellhom tneħħija tal-krejatinina ta' <50ml/min.
English: Four (0.3%) non-randomised patients experienced thrombus in the diagnostic catheter during coronary angiography.
Maltese: Erba' (0.3%) pazjenti mhux randomised kellhom trombus fil-kateter dijanjostiku waqt anġiografija koronarja.
English: 7.5 mg once a day
Maltese: 7.5 mg darba kuljum
English: There are two types of syringes:
Maltese: Hemm żewġ tipi ta' siringi :
English: Uncommon: rash, pruritus
Maltese: Mhux komuni: dardir, rimettar
English: The incidences of adjudicated guiding catheter thrombus were 0.1% (1/1002) and 0.5% (5/1024), in patients randomised to “standard dose” and “low dose” UFH respectively during PCI.
Maltese: L-inċidenzi ta' trombus fil-kateter kienu 0.1% (1/1002) u 0.5% (5/1024), f'pazjenti randomised għal
English: • if you have a risk of uncontrolled bleeding (haemorrhage) including:
Maltese: • jekk għandek riskju ta' ħruġ ta' demm mhux ikkontrollat (emorraġija), li tinkludi :
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection, 2 pre-filled syringes with an automatic safety system Solution for injection, 7 pre-filled syringes with an automatic safety system Solution for injection, 10 pre-filled syringes with an automatic safety system Solution for injection, 20 pre-filled syringes with an automatic safety system Solution for injection, 2 pre-filled syringes with a manual safety system Solution for injection, 10 pre-filled syringes with a manual safety system Solution for injection, 20 pre-filled syringes with a manual safety system
Maltese: Soluzzjoni għall-injezzjoni, 2 siringi mimlijin lesti batika.a ta' sikurezzasigurtà Soluzzjoni għall-injezzjoni, 10 siringi mimlijin lesti btikatema manwali taa sigurtà Soluzzjoni għall-injezzjoni, 20 siringi mimlijin lesti btikatema manwali taa sigurtà
English: Treatment of ST segment elevation myocardial infarction (STEMI) OASIS 6 was a double blind, randomised study assessing the safety and efficacy of fondaparinux 2.5 mg once daily, versus usual care (placebo (47%) or UFH (53%) in approximately 12,000 patients with STEMI.
Maltese: OASIS 6 kien studju double blind, mhux bażat fuq xi għażla ppjanata, li jassessja s-sigurtà u leffikaċja ta' 2.5 mg fondaparinux kuljum, kontra kura normali (plaċebo 47% jew UFH(53%)) f'madwar 12000 pazjent bi STEMI.
English: • 5 mg fondaparinux sodium in 0.4 ml solution for injection
Maltese: • 5 mg ta' fondaparinux sodium f'0.4 ml ta' soluzzjoni għall-injezzjoni
English: Hepatic impairment - Following a single, subcutaneous dose of fondaparinux in subjects with moderate hepatic impairment (Child-Pugh Category B), total (i.e., bound and unbound) Cmax and AUC were decreased by 22% and 39%, respectively, as compared to subjects with normal liver function.
Maltese: Indeboliment tal-fwied - Wara doża waħda mogħtija taħt il-ġilda ta' fondaparinux, f'suġġetti b'indeboliment tal-fwied moderat (Child-Pugh Category B), Cmax totali (jiġifieri marbut u mhux marbut) u AUC tnaqqsu b'22% u 39%, rispettivament, meta mqabbla ma' suġġetti b'funzjoni talfwied normali.
English: In clinical studies performed with fondaparinux, oral anticoagulants (warfarin) did not interact with the pharmacokinetics of fondaparinux; at the 10 mg dose used in the interaction studies, fondaparinux did not influence the anticoagulation monitoring (INR) activity of warfarin.
Maltese: Fid-doża ta' fondaparinux (10 mg) li ntużat flistudji ta' interazzjoni, fondaparinux ma kellu ebda effett fuq l-attivita` ta' l-osservazzjoni ta' antikoagulazzjoni (INR) ta' warfarin.
English: • 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.
Maltese: • 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.
English: The incidence of adjudicated major bleeding was 2.1% (fondaparinux) vs. 4.1% (enoxaparin) up to and including Day 9 in the Phase III UA/NSTEMI study, and the incidence of adjudicated severe haemorrhage by modified TIMI criteria was 1.1% (fondaparinux) vs. 1.4% (control [UFH/placebo]) up to and including Day 9 in the Phase III STEMI study.
Maltese: 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.
English: Fondaparinux should be used with caution in these patients (see section 4.4).
Maltese: fondaparinux (ara sezzjoni 4.4).
English: Prevention of Venous Thromboembolic Events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery.
Maltese: Prevenzjoni kontra eventi tromboemboliċi fil-vini (VTE) f'adulti li għaddejjin minn kirurġija ortopedika maġġuri tal-partijiet t'isfel tal-ġisem bħal fratturi fil-ġenb (hip), kirurġija maġġuri flirkoppa jew kirurġija għal sostituzzjoni tal-ġenb.
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa.
Maltese: L-attivita` antitrombotika ta' fondaparinux hija riżultat ta' impediment selettiv ta' Fattur Xa medjat b'antithrombin III (ATIII) .
English: • Treatment of UA/NSTEMI and STEMI - For the treatment of UA/NSTEMI and STEMI, there are limited clinical data available on the use of fondaparinux 2.5mg once daily in patients with creatinine clearance between 20 and 30 ml/min.
Maltese: • 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 talkrejatinina bejn 20 u 30 ml/min.
English: Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE and aged <65 years, 65-75 and >75 years were 3.0 %, 4.5 % and 6.5 %, respectively.
Maltese: 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.
English: • Prevention of VTE - Patients with body weight <50 kg are at increased risk of bleeding.
Maltese: • Prevenzjoni ta' VTE - Pazjenti li għandhom piż < 50 kg għandhom riskju ikbar ta' fsada.
English: Syringe manual system
Maltese: Sistema manwali ta' siringa
English: These agents include desirudin, fibrinolytic agents, GP IIb/IIIa receptor antagonists, heparin, heparinoids, or Low Molecular Weight Heparin (LMWH).
Maltese: Dawn l-aġenti jinkludu desirudin, aġenti fibrinolitiċi, antagonisti ta' riċetturi GP Iib/IIIa, heparin, heparinoids, jew Heparin ta' Piż Molekulari
English: Paediatric patients - Fondaparinux has not been investigated in this population for the prevention of VTE or for the treatment of superficial vein thrombosis or acute coronary syndrome (ACS).
Maltese: Pazjenti pedjatriċi - Fondaparinux ma ġiex investigat f'din il-popolazzjoni għall-prevenzjoni ta' VTE jew għall-kura ta' trombożi fil-vini superfiċjali jew tas-sindrome koronarju akut (ACS).
English: 5 mg once a day
Maltese: 5 mg darba kuljum
English: Arixtra is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Maltese: Arixtra hija disponibbli f'daqsijiet ta' pakketti ta' 2, 7, 10 u 20 siringi mimlija lesti.
English: In hip fracture patients, associated with their increased age, fondaparinux steady state plasma concentrations are: Cmax (mg/l) - 0.50 (32%), Cmin (mg/l) - 0.19 (58%).
Maltese: marbuta ma' l-eta` avvanzati tagħhom, il-konċentrazzjonijiet fissi fil-plażma ta' fondaparinux kienu ta': Cmax (mg/l) - 0.50 (32%), Cmin (mg/l) - 0.
English: The corresponding incidences in patients receiving the recommended regimen of enoxaparin in the treatment of DVT were 2.5%, 3.6% and 8.3% respectively, while the incidences in patients receiving the recommended regimen of UFH in the treatment of PE were 5.5%, 6.6% and 7.4%, respectively.
Maltese: Meta maqsumin f'gruppi fl-istess mod, il-każi f'pazjenti li jieħdu d-dożaġġ rakkomandat ta' enoxaparin fit-trattament ta' DVT kienu ta' 2.5%, 3.6 % u 8.3 % rispettivament, u l każi f'pazjenti li jieħdu d-dożaġġ rakkomandat ta' UFH fit-trattament ta' PE kienu ta' 5.5%, 6.6 % and 7.4 % rispettivament.
English: Infections and infestations
Maltese: Infezzjonijiet u Infestazzjonijiet
English: The pharmacokinetics of fondaparinux has not been studied in patients with severe hepatic impairment (see sections 4.2 and 4.4).
Maltese: Il-farmakokinetika ta' fondaparinux ma ġietx studjata f'pazjenti b'indeboliment qawwi tal-fwied (ara sezzjonijiet 4.2 u 4.4).
English: Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis (see sections 4.2 and 5.1).
Maltese: Kura ta' adulti bi trombożi spontanja, akuta u sintomatika fil-vini superfiċjali tar-riġlejn mingħajr trombożi fil-vini tal-fond flimkien magħha (ara sezzjonijiet 4.2 u 5.1).
English: EU/1/02/206/001-004 EU/1/02/206/021 EU/1/02/206/022 EU/1/02/206/023
Maltese: EU/1/02/206/021 EU/1/02/206/022 EU/1/02/206/023
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu
English: 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).
Maltese: 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.
English: • collapse.
Maltese: Użu subkutanju.
English: Following a single subcutaneous injection of fondaparinux 2.5 mg to young healthy subjects, peak plasma concentration (mean Cmax = 0.34 mg/l) is obtained 2 hours post-dosing.
Maltese: Wara injezzjoni subkutanja waħda ta' fondaparinux 2.5 mg lil suġġetti żgħar u f'saħħithom, konċentrazzjoni massima fil-plażma (medja Cmax = 0.34 mg/l) huwa ottenut 2 sigħat wara d-doża.
English: 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).
Maltese: L-inċidenza tal-mortalita' mill-kawżi kollha fit-30 jum tnaqqset ukoll sinifikament minn 8.9% filgrupp ta' kontroll għal 7.8% fil-grupp fondaparinux (hazard ratio 0.87, 95% CI, 0.77; 0.98, p = 0.02).
English: • wound infection
Maltese: • infezzjoni fil-ferita
English: Arixtra 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Maltese: Arixtra 7.5 mg/0.6 ml jinstab f'pakketti ta' 2, 7, 10, u 20 siringi mimlija lesti.
English: • 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).
Maltese: • 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).
English: The primary adjudicated endpoint was a composite of death, myocardial infarction (MI) and refractory ischaemia (RI) within 9 days of randomisation.
Maltese: 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.
English: By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by antithrombin.
Maltese: 300 darba) in-newtralizzazzjoni naturali ta' Fattur Xa permezz ta' antitrombin.
English: • after the expiry date shown on the label and carton
Maltese: • wara d-data ta' meta tiskadi li tidher fuq it-tabella u l-kaxxa
English: • syringe with blue plunger and a manual safety system.
Maltese: • siringa bi planġer blu u b'sistema manwali ta' sigurtà.
English: The primary efficacy outcome, a composite of symptomatic PE, symptomatic DVT, symptomatic superficial-vein thrombosis extension, symptomatic superficial-vein thrombosis reoccurrence, or Death up to Day 47, was significantly reduced from 5.9% in placebo patients to 0.9% in those receiving fondaparinux 2.5 mg (relative risk reduction: 85.2%; 95% CIs, 73.7% to 91.7% [p<0.001]).
Maltese: Ir-riżultat primarju ta' effikaċja, taħlita ta' PE sintomatika, DVT sintomatika, estensjoni ta' trombożi fil-vini superfiċjali sintomatika, trombożi fil-vini superfiċjali li sseħħ mill-ġdid u tkun sintomatika, jew Mewt sal-Jum 47, tnaqqas b'mod sinifikanti minn 5.9% f'pazjenti fuq plaċebo għal 0.9% f'dawk li ngħataw fondaparinux 2.5 mg (tnaqqis relattiv tar-riskju: 85.
English: Usual dose
Maltese: Doża standard ta'
English: Oral anticoagulants (warfarin), platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Maltese: Sostanzi orali kontra l-koagulazzjoni tad-demm (warfarin), impedituri għat-tgħaqid tad-demm (acetylsalicylic acid), NSAIDs (piroxicam) u digoxin ma kellhomx interazzjoni mal-farmakokinetiċi ta' fondaparinux.
English: Parts of the syringes: 1 Needle shield 2 Plunger 3 Finger-grip 4 Security sleeve
Maltese: Soluzzjoni għall-injezzjoni, 2 siringi mimlijin lesti b'sistema manwali ta' sigurtà
English: 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).
Maltese: > 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).
English: As renal function is generally decreasing with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
Maltese: Il-funzjoni renali ġeneralment tonqos bl-eta`, u għalhekk pazjenti anzjani jistgħu jkollhom eliminazzjoni mnaqqsa u esponiment akbar ta' fondaparinux (ara sezzjoni 5.2).
English: 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.
Maltese: 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.
English: Renal impairment - Compared with patients with normal renal function (creatinine clearance > 80 ml/min) undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, 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).
Maltese: Indeboliment renali - Il-clearance tal-plażma hija minn 1.2 sa 1.4 l-darba inqas f'pazjenti b' indeboliment renali ħafif (clearance tal-krejatinina minn 50 sa 80 ml/min) u medja ta' darbtejn inqas f'pazjenti b'indeboliment renali moderat (clearance tal-krejatinina minn 30 sa 50 ml/min), meta mqabbla ma pazjenti b'funzjoni renali normali (clearance tal-krejatinina > 80 ml/min), li jgħaddu minn kirurġija ortopedika u fuq fondaparinux 2.5 mg kuljum.
English: Patients eligible for fondaparinux 2.5 mg treatment should have acute, symptomatic, isolated, spontaneous superficial-vein thrombosis of the lower limbs, at least 5 cm long and documented by ultrasonographic investigation or other objective methods.
Maltese: Pazjenti eliġibbli għal kura b'fondaparinux 2.5 mg għandu jkollhom trombożi akuta, sintomatika, iżolata u spontanja fil-vini superfiċjali tar-riġlejn, li tkun mill-anqas twila 5 ċm u ddokumentata permezz ta' investigazzjoni ultrasonografika jew b'metodi oġġettivi oħra.
English: • Patients who are to undergo coronary artery bypass graft (CABG) surgery 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.
Maltese: 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.
English: 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).
Maltese: 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).
English: Type I glass barrel (1 ml) affixed with a 27 gauge x 12.7 mm needle and stoppered with a bromobutyl or chlorobutyl elastomer plunger stopper.
Maltese: Tubu ċilindriku tal-ħġieġ Tip1 (1 ml) mehmuż b' labra kalibru 27 ta' 12.7 mm u magħluqa b'tapp planġer tal-bromobutyl jew chlorobutyl elastomer.
English: The needle protection system of the Arixtra pre-filled syringes have been designed with a safety system to protect from needle stick injuries following injection.
Maltese: Is-sistema ta' protezzjoni tal-labra tas-siringi mimlija lesti Arixtra giet diżinjata b'sistema ta' sikurezza biex tipproteġi minn feriti bil-labra wara l-injezzjoni.
English: When required, concomitant therapy with vitamin K antagonist should be administered in accordance with the information of Section 4.5.
Maltese: Meta jkun hemm bżonn terapija konkomitanti ma' antagonist tal-vitamina K għandha tiġi amministrata skond l-informazzjoni mogħtija f'sezzjoni 4.5.
English: Prevention of Venous Thromboembolic Events (VTE) in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1).
Maltese: Il-prevenzjoni ta' Każi Trombo-emboliċi Venużi (VTE) f'adulti li jgħaddu minn kirurġija ta' laddomenu li huma meqjusa f'riskju għoli ta' kumplikazzjonjiet trombo-emboliċi, bħal dawk l-pazjenti li jgħaddu minn kirurġija ta' kanċer fl-addomenu (are sezzjoni 5.1).
English: Arixtra 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Maltese: Arixtra 10 mg/0.8 ml jinstab f'pakketti ta' 2, 7, 10, u 20 siringi mimlija lesti.
English: Major bleeding during the initial treatment period was observed in 1.3% of fondaparinux patients, compared to 1.1% with unfractionated heparin.
Maltese: Fsada maġġuri fil-perjodu tal-bidu tat-trattament kienet osservata f' 1.3% tal-pazjenti fuq fondaparinux meta mqabbel ma' 1.1% fil-pazjenti fuq heparin mhux frazzjonat.
English: No dosage reduction is required for patients with creatinine clearance > 20 ml/min.
Maltese: M'hemmx bżonn titnaqqas id-doża f'pazjenti bi clearance tal-krejatinina > 20 ml/min.