FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean treatment duration was 5.5 days in the fondaparinux group and 5.2 days in the enoxaparin group.
Maltese: It-tul medju ta' trattament kien 5.5 jiem fil-każ tal-grupp fondaparinux u 5.2 jiem fil-każ tal-grupp enoxaparin.
English: Picture E
Maltese: Stampa E
English: 10 mg once a day.
Maltese: 10 mg darba kuljum.
English: However, rare spontaneous reports of aPTT prolongation have been received.
Maltese: Madankollu, waslu rapporti spontanji rari ta' titwil fl'aPTT.
English: Uncommon: anaemia, thrombocytopaenia
Maltese: Mhux komuni: anemija, tromboċitopenja
English: All patients received standard treatments for STEMI, including primary PCI (31%), thrombolytics (45%) or no reperfusion (24%).
Maltese: Il-pazjenti kollha ħadu trattamenti normali għal STEMI, inklużi PCI primarja (31%), sustanzi trombolitiċi (45% ) jew ebda reperfużjoni (24%).
English: The difference in mortality was statistically significant in stratum 1 (placebo comparator) but not in stratum 2 (UFH comparator).
Maltese: Id-differenza fil-mortalità kienet statistikament sinifikanti f'stratum 1 (komparatur plaċebo) imma mhux f'stratum 2 (komparatur UFH).
English: The mean treatment duration was 6.2 days on fondaparinux.
Maltese: It-tul medju tat-trattament kien ta' 6.2 jiem fuq fondaparinux.
English: Syringe automatic system
Maltese: Sistema awtomatika ta' siringa
English: Do not use Arixtra:
Maltese: Tużax Arixtra:
English: In an open-label study, 24 paediatric patients (n=10, age 1 to ≤ 5 years weight range 8-20 kg; n=7, age 6 to ≤ 12 years weight range 17-47 kg and n=7 age 13 to ≤ 18 years weight range 47-130 kg) diagnosed with venous thrombosis at study entry were administered fondaparinux.
Maltese: Fi studju open-label, 24 pazjenti pedjatriku (n=10, età minn 1 sa ≤ 5 snin piż f'medda ta' bejn 8-20 kg; n=7, età minn 6 sa ≤ 12-il sena piż f'medda ta' bejn 17-47 kg u n=7 età minn 13 sa ≤ 18-il sena piż f'medda ta' bejn 47-130 kg) b'dijanjosi ta' trombożi fil-vini meta ddaħħlu fl-istudju ngħataw fondaparinux.
English: 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.
Maltese: 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
English: (2) Npn stands for non-protein-nitrogen such as urea, uric acid, amino acid, etc.
Maltese: (2) Npn iffisser nitroġenu mhux minn proteini bħal urea, aċidu uriku, amino aċidi, etc.
English: After subcutaneous dosing, fondaparinux is completely and rapidly absorbed (absolute bioavailability 100%).
Maltese: Wara dożaġġ subkutanju, fondaparinux huwa assorbit kompletament u malajr (biodisponibilità assoluta 100 %).
English: Arixtra contains sodium
Maltese: Arixtra fih sodium
English: The incidence of symptomatic DVT was similar between treatment groups: 6 patients (0.4%) in the fondaparinux group vs 5 patients (0.3%) in the dalteparin group.
Maltese: sintomatiku kien simili bejn il-gruppi ta' trattamenti: 6 pazjenti (0.4%) fil-grupp ta' fondaparinux meta mqabbel ma' 5 pazjenti (0.3%) fil-grupp ta' dalteparin.
English: There are different syringes for the 5 mg, 7.5 mg and 10 mg doses.
Maltese: Hemm siringi differenti għad-dożi ta' 5mg, 7.5mg u 10mg.
English: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland Manufacturer:
Maltese: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Irlanda
English: The majority of patients were Hispanic (67%) and 58% were male.
Maltese: Il-maġġoranza tal-pazjenti kienu ta' dixxendenza Spanjola (67%) u 58% kienuta' sess maskili.
English: There are no data available on the effect of fondaparinux on human fertility.
Maltese: M'hemmx dejta disponibbli dwar l-effett ta' fondaparinux fuq il-fertilità umana.
English: The primary efficacy endpoint was the composite of confirmed symptomatic recurrent non-fatal VTE and fatal VTE reported up to Day 97.
Maltese: L-effikaċja primarja finali ġiet minn ġabra ta' ta' kazi confirmati ta' VTE sintomatiku mhux fatali rikorrenti u VTE fatali rappurtati sa Ġurnata 97.
English: Of the patients treated with a thrombolytic, 84% were treated with a non-fibrin specific agent (primarily streptokinase).
Maltese: Mill-pazjenti trattati b'sustanza trombolitika, 84% ħadu trattament b'aġent mhux speċifiku għal-fibrin (primarjament streptokinase).
English: Race - Pharmacokinetic differences due to race have not been studied prospectively.
Maltese: Razza - Differenzi farmakokinetiċi minħabba razza ma ġewx studjati prospettivament.
English: Fondaparinux significantly reduced the overall rate of VTE compared to placebo [18 patients (5.6%) vs 34 patients (10.5%), respectively].
Maltese: Fondaparinux naqqas sinifikament ir-rata sħiha ta' VTE meta mqabbel mal-plaċebo [18 patients (5.6%) vs 34 pazjenti (10.
English: Picture 3.
Maltese: II u III.
English: Other medicines and Arixtra
Maltese: Mediċini oħra u Arixtra
English: Associated terminal half-life values were 29 h in moderate and 72 h in patients with severe renal impairment.
Maltese: Valuri tal-half life terminali assoċjati kienu 29 h fil-moderati u 72 h f'pazjenti b'indeboliment renali akut.
English: • fever
Maltese: • fwawar
English: For step-by-step instructions please see over the page
Maltese: Fil-pazjenti ta' l-istudju fi Fasi
English: The incidence of each thromboembolic component of the primary outcome was also significantly reduced in fondaparinux patients as follows: symptomatic PE [0 (0%) vs 5 (0.3%) (p=0.031)], symptomatic DVT [3 (0.2%) vs 18 (1.2%); relative risk reduction 83.4% (p<0.001)], symptomatic superficial-vein thrombosis extension [4 (0.3%) vs 51 (3.4%); relative risk reduction 92.2% (p<0.001)], symptomatic superficial-vein thrombosis reoccurrence [5 (0.3%) vs 24 (1.6%); relative risk reduction 79.2% (p<0.001)].
Maltese: [p<0.001]). L-inċidenza ta' kull komponent tromboemboliku tar-riżultat primarju wkoll tnaqqset b'mod sinifikanti fil-pazjenti ta' fondaparinux kif ġej: PE sintomatika [0 (0%) vs 5 (0.3%) (p=0.031)], DVT sintomatika [3 (0.2%) vs 18 (1.2%); tnaqqis relattiv tar-riskju 83.4% (p<0.001)], estensjoni ta' trombożi fil-vini superfiċjali sintomatika [4 (0.3%) vs 51 (3.4%); tnaqqis relattiv tar-riskju 92.2%
English: LIST OF EXCIPIENTS Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.
Maltese: TA' EĊĊIPJENTI Fiha wkoll: sodium chloride, ilma għal injezzjonijiet, hydrochloric acid, sodium hydroxide.
English: However, rare spontaneous reports of HIT in patients treated with fondaparinux have been received.
Maltese: Madanakollu, waslu rapporti spontanji rari b'TIE f'pazjenti trattati b'fondaparinux.
English: Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 4.1%, respectively).
Maltese: enoxaparin (rati ta' VTE 3.9% u 4.1%, rispettivament).
English: By Day 9, 1.1% of patients treated with fondaparinux and 1.4% of control patients experienced a severe haemorrhage.
Maltese: Mad-9 jum, 1.1% ta' pazjenti trattati b'fondaparinux u 1.4% tal-pazjenti taħt kontroll esperjenzaw emorraġija qawwija.
English: INFORMATION IN BRAILLE arixtra 10 mg
Maltese: arixtra 10 mg
English: Rare: abdominal pain
Maltese: Rari: uġigħ addominali
English: The associated 5th and 95th percentiles are, respectively, 0.97 and 1.92 for Cmax (mg/l), and 0.24 and 0.95 for Cmin (mg/l).
Maltese: Il-ħames u l-ħamsa u disgħin percentiles assoċjati kienu, rispettivament, 0.97 and 1.92 for Cmax (mg/l), u 0.24 u 0.95 għal Cmin (mg/l).
English: Fondaparinux also significantly reduced the rate of adjudicated fatal PE [0 patients (0.0%) vs 5 patients (1.2%), respectively].
Maltese: Fondaparinux naqqas sinifikament ukoll ir-rata ta' PE li kienu aġġudikati fatali [0 pazjenti (0.0%) vs 5 pazjenti (1.2%),
English: Major bleeding was observed in 3.4% of the patients in the fondaparinux group and in 2.4% of the dalteparin group.
Maltese: Fsada maġġuri kienet osservata f' 3.4% tal-pazjenti fil-grupp ta' fondaparinux u f' 2.4% fil-grupp ta' dalteparin.
English: Fondaparinux provided a significant reduction in the overall rate of VTE compared with placebo [3 patients (1.4%) vs 77 patients (35%), respectively].
Maltese: pparagunata ma' plaċebo [3 pazjenti (1.4 %) vs 77 pazjent (35 %) rispettivament}.
English: The fondaparinux clinical program in treatment of Venous Thromboembolism was designed to demonstrate the efficacy of fondaparinux for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Maltese: Il-programm kliniku ta' fondaparinux fi trattament ta' Tromboemboliżmu Venuż kien iddiżinjat biex juri l-effikaċja ta' fondaparinux fit-trattament ta' trombożi f' vina fonda (DVT) u emboliżmu pulmonari (PE).
English: Pharmacotherapeutic group: antithrombotic agents.
Maltese: Kategorija farmakoterapewtika: aġent antitrombotiku Kodiċi ATC:
English: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 20 ml/min.
Maltese: - Sensittività eċċessiva għal fondaparinux jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 - Fsada attiva klinikament sinifikanti - Endokardite batterika akuta - Indeboliment sever renali definit bi clearance tal-krejatinina ta' < 20 ml/min
English: There is no known antidote to fondaparinux.
Maltese: M'hemmx antidotu għal fondaparinux.
English: : + 33 (0)1 39177000 aspenmedinfo@professionalinformation.co.uk
Maltese: Tél.: + 33 (0)1 39177000 aspenmedinfo@professionalinformation.co.uk
English: Common: bleeding (gastrointestinal, haematuria, haematoma, epistaxis, haemoptysis, utero-vaginal haemorrhage, haemarthrosis, ocular, purpura, bruise)
Maltese: ematoma, epistaxis, emoptisis, emorraġija uteruvaġinali, emartrosis, okulari, purpura, tbenġil)
English: A randomised, open-label, clinical trial was conducted in patients with acute symptomatic PE.
Maltese: Studju kliniku open-label u randomised kien magħmul fuq pazjenti b' PE sintomatiku akut.
English: Fondaparinux is a synthetic and selective inhibitor of activated Factor X (Xa).
Maltese: Fondaparinux huwa impeditur sintetiku u selettiv ta' Fattur X attivat (Xa).
English: Adverse reactions in medical patients
Maltese: Reazzjonijiet avversi f'pazjenti mediċi
English: 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 evaluated up to day 11 after surgery, irrespective of the type of surgery performed.
Maltese: F'ġabra ta' analiżi ta' dawn l-istudji, ir-reġimen tad-doża rakkomandata ta' fondaparinux kontra 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.
English: Rare: non-protein-nitrogen (Npn) 2 increased
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Rari: żieda fin-nitroġenu mhux minn proteini (Npn)2
English: Thus, fondaparinux is not expected to interact with other medicinal products in vivo by inhibition of CYP-mediated metabolism.
Maltese: Għalhekk fondaparinux mhux mistenni li jkollu interazzjoni ma' prodotti mediċinali in vivo bl-inibizzjoni ta' metaboliżmu medjat-CYP.
English: INFORMATION IN BRAILLE arixtra 7.5 mg
Maltese: arixtra 7.5 mg
English: • 10 mg fondaparinux sodium in 0.8 ml solution for injection The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/or sodium hydroxide to adjust the pH (see section 2).
Maltese: • 10 mg ta' fondaparinux sodium f'0.8 ml ta' soluzzjoni għall-injezzjoni Is-sustanzi l-oħra huma sodium chloride, ilma għal injezzjonijiet, u hydrochloric acid u jew sodium hydroxide biex jaġġustaw il-pH (ara sezzjoni 2).
English: It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).
Maltese: Hija disponibbli f'pakketti ta' 2, 7, 10 u 20 siringi mimlija lesti (jista' jkun li mhux il-pakketti taddaqsijiet kollha jkunu fis-suq).
English: In vitro, fondaparinux is highly and specifically bound to antithrombin protein with a dose-dependant plasma concentration binding (98.6% to 97.0% in the concentration range from 0.5 to 2 mg/l).
Maltese: In vitro fondaparinux huwa marbut ħafna u speċifikament mal-proteina antitrombin b'mod dipendenti mad-doża u mal konċentrazzjoni fil-plażma (98.6 % sa 97.0 % fil-firxa tal-konċentrazzjoni bejn 0.5 sa 2 mg/l).
English: • Do not inject Arixtra into muscle.
Maltese: • Tinjettax Arixtra ġo muskolu.
English: 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).
Maltese: 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).
English: There are different syringes for the 2.5 mg and 1.5 mg doses.
Maltese: Hemm siringi differenti għad-doża ta' 2.5 mg u dik ta' 1.5 mg.
English: Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Maltese: ematoma, epistaxis, emoptisis, emorraġija uteruvaġinali, emartrosis, okulari, purpura, tbenġil) Mhux komuni: anemija, tromboċitopenja Rari: fsada oħra (epatika, retroperitonjali, intrakranja/intraċerebrali), tromboċitemija
English: Clinical studies
Maltese: Studji kliniċi
English: Paediatric patients - Limited data are available in paediatric patients (see section 5.1).
Maltese: Pazjenti pedjatriċi : Hija disponibbli dejta limitata f'pazjenti pedjatriċi (ara sezzjoni 5.1)..
English: At the 10 mg dose used in interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of warfarin.
Maltese: 10 mg użata f' studji ta' interazzjoni, fondaparinux ma kellux effett sinifikanti fuq l-attivita` antikoagulanti (INR) ta' warfarin.
English: Fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50kg, ≤ 100 kg) or 10 mg (body weight >100 kg) SC once daily was compared to unfractionated heparin IV bolus (5,000 IU) followed by a continuous IV infusion adjusted to maintain 1.5-2.5 times aPTT control value.
Maltese: Fondaparinux 5 mg (piż < 50 kg), 7.5 mg (piż ≥ 50 kg, ≤ 100 kg) jew 10 mg (piż >100 kg) SC darba kuljum kien mqabbel ma' leparina mhux frazzjonata IV bolus (5,000IU) segwit minn infużjoni IV kontinwu li kien aġġustat biex jinżamm 1.5-2.5 darbiet l-valur ta' kontrol aPTT.
English: The subcutaneous injection is administered in the same way as with a classical syringe.
Maltese: L-injezzjoni subkutanja hi amministrata fl-istess mod bħal siringa klassika.
English: In this study, the incidence of total VTE was 4.6% (47/1,027) with fondaparinux, versus 6.1%: (62/1,021) with dalteparin: odds ratio reduction [95%CI] = -25.8% [-49.7%, 9.5%].
Maltese: 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%
English: Fondaparinux does not bind significantly to other plasma proteins, including platelet factor 4 (PF4).
Maltese: Fondaparinux ma jorbotx b'mod sinifikattiv ma' proteini tal-plażma oħrajn, inklużi fattur 4 talplejtlets (PF4).
English: The diagnosis was confirmed by objective testing (lung scan, pulmonary angiography or spiral CT scan).
Maltese: Iddijanjosi kien konfermat b' testijiet oġġettivi (skan tal-pulmun, anġjografija pulmonari jew CT skan spirali).
English: In a randomised, double-blind, clinical trial in patients with a confirmed diagnosis of acute symptomatic DVT, fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50 kg, ≤ 100 kg) or 10 mg (body weight >100 kg) SC once daily was compared to enoxaparin sodium 1 mg/kg SC twice daily.
Maltese: Fi studju kliniku double-blind u randomised, f'pazjenti b'dijagnożi konfermata ta' DVT sintomatika akuta, fondaparinux 5 mg (piż < 50 kg), 7.5 mg (piż ≥ 50 kg, ≤ 100 kg) jew 10 mg (piż >100 kg) SC
English: 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).
Maltese: 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).
English: Therefore adjunctive UFH should be used during non-primary PCI according to standard practice (see posology in section 4.2).
Maltese: UFH skond il-prattika standard (ara sezzjoni 4.2).
English: The effects on the incidence of MI and RI were not statistically different between the fondaparinux and enoxaparin treatment groups.
Maltese: L-effetti fuq l-inċidenza ta' MI u RI ma kienux statistikament differenti bejn il-grupp ta' trattament b'fondaparinux u dak b'enoxaparin.
English: Signs include:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: 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.
Maltese: 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.
English: A pilot dose-finding and pharmacokinetic study of fondaparinux in children with deep vein thrombosis
Maltese: Studju pilota biex tinstab id-doża u farmakokinetika ta' fondaparinux fi tfal bi trombożi tal-vini fil-fond
English: INFORMATION IN BRAILLE arixtra 1.5 mg
Maltese: arixtra 1.5 mg
English: Fondaparinux also provided a significant reduction in the rate of symptomatic VTE (DVT, and / or PE) [1 (0.3%) vs 9 (2.7%) patients, respectively] including two fatal PE reported in the placebo group.
Maltese: u/jew PE) [1(0.3 %0 vs 9 (2.7 %) pazjenti, rispettivament] inklużi żewġ PE fatali rrapurtati fil-grupp plaċebo.
English: The safety of fondaparinux 2.5 mg has been evaluated in 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days, in 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week, 1,407 patients undergoing abdominal surgery treated up to 9 days, and in 425 medical patients who are at risk for thromboembolic complications treated up to 14 days.
Maltese: Is-sigurta` ta' fondaparinux 2.5 mg ġiet evalwata f'3,595 pazjent għaddejjin minn kirurġija ortopedika maġġuri fir-riġlejn li ġew trattati għal mhux iżjed minn 9 t' ijiem, f'327 pazjent għaddejjin minn kirurġija ta' ksur ta' l-għadma tal-ġenbejn li ġew trattati għal 3 ġimgħat wara profilassi inizjali ta' ġimgħa, 1,407 pazjent għaddejjin minn kirurġija ta' l-addomenu li ġew trattati mhux iżjed minn 9 t'ijiem, u f'425 pazjenti mediċi li huma f'riskju ta' kumplikazzjonijiet ta' trombo-emboliżmu li ġew trattati għal 14 il-ġurnata.
English: A treatment duration of 6-14 days has been clinically studied in medical patients (see section 5.1).
Maltese: F'pazjenti mediċi, ġie studjat klinikament trattament ta' 6 - 14 il-ġurnata (ara sezzjoni 5.1).
English: In the predefined stratum comparing fondaparinux to placebo (i.e patients treated with nonfibrin 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).
Maltese: 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 fit30 jum tnaqqset sinifikament minn 14.0% fuq plaċebo għal 11.3% (hazard ratio 0.80, 95% CI, 0.69.
English: At the doses used for treatment, fondaparinux does not, to a clinically relevant extent, 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.
Maltese: Fid-doza li tintuża fit-trattament, fondaparinux m'għandux effett klinikament relevanti fuq testijiet tal koagulazzjoni ta' rutina bħal activated partial thromboplastin time (aPTT), activated clotting time (ACT) jew prothrombin time (PT) / International Normalised Ratio (INR) fuq il- plażma, u lanqas ilħin biex jieqaf id-demm (bleeding time) jew l-attivita` fibrinolitika.
English: 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).
Maltese: 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).
English: Platelet inhibitors (acetylsalicylic acid), NSAIDs (piroxicam) and digoxin did not interact with the pharmacokinetics of fondaparinux.
Maltese: Inibituri tal-plejtlets (acetylsalicylic acid), NSAIDs (piroxicam) u digoxin ma kellhomx effett fuq ilfarmakokinetika ta' fondaparinux.
English: The mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients with VTE receiving the fondaparinux proposed dose regimen once daily are: Cmax (mg/l) - 1.41 (23 %), Tmax (h) - 2.4 (8%) and Cmin (mg/l) -0.52 (45 %).
Maltese: L-estimi medji (CV%) tal-parametri farmakokinetiċi fissi ta' fondaparinux f'pazjenti b' VTE fuq id-dożaġġ propost ta' fondaparinux huma: Cmax (mg/l) - 1.41 (23 %), Tmax (s) - 2.4 (8%) u Cmin (mg/l) -0.
English: • anxiety or confusion
Maltese: • anzjeta` jew konfużjoni
English: The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
Maltese: L-inċidenza ta' VTE sintomatika, inkluż PE ma kienx differenti b'mod sinifikanti bejn il-gruppi ta' trattament.
English: INFORMATION IN BRAILLE arixtra 2.5 mg
Maltese: arixtra 2.5 mg
English: Randomised patients received either “low dose” UFH regimen (50 U/kg irrespective of planned GPIIb/IIIa use; non ACT guided) or “standard dose” UFH regimen (no GPIIb/IIIa use: 85 U/kg, ACT guided; planned GPIIb/IIIa use: 60 U/kg, ACT guided) immediately prior to the start of the PCI.
Maltese: Pazjenti randomised jew irċivew skeda ta' “doża baxxa” ta' UFH (50 U/kg irrispettivament mill-użu ppjanat ta' GPIIb/IIIa; mhux iggwidat b'ACT) jew inkella skeda ta' “doża standard” ta' UFH (l-ebda użu ta' GPIIb/IIIa: 85 U/kg, iggwidat b'ACT; użu ppjanat ta' GPIIb/IIIa: 60
English: The safety of fondaparinux 2.5 mg has been evaluated in: - 3,595 patients undergoing major orthopaedic surgery of the lower limbs treated up to 9 days - 327 patients undergoing hip fracture surgery treated for 3 weeks following an initial prophylaxis of 1 week - 1,407 patients undergoing abdominal surgery treated up to 9 days - 425 medical patients who are at risk for thromboembolic complications treated up to 14 days - 10,057 patients undergoing treatment of UA or NSTEMI ACS - 6,036 patients undergoing treatment of STEMI ACS.
Maltese: ġimgħat wara profilassi inizjali ta' ġimgħa - 1,407 pazjent għaddejjin minn kirurġija ta' l-addomenu li ġew trattati mhux iżjed minn 9 t'ijiem - 425 pazjenti mediċi li huma f'riskju ta' kumplikazzjonijiet ta' trombo-emboliżmu li ġew trattati għal 14 il-ġurnata - 10,057 pazjenti li qed jirċievu trattament għal UA jew NSTEMI ACS - 6,036 pazjenti li qed jirċievu trattament għal STEMI ACS.
English: Posology
Maltese: Stampa