FrancophonIA/ELRC3.0 huggingface dataset:
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: Fondaparinux ipprovda wkoll tnaqqis sinifikanti fir-rata ta' VTE sintomatiku (DVT, u/jew PE) [1(0.3 %0 vs 9 (2.7 %) pazjenti, rispettivament] inklużi żewġ PE fatali rrapurtati fil-grupp plaċebo.
English: Picture F
Maltese: Figura F
English: Do not use Quixidar:
Maltese: Tużax Quixidar:
English: • swelling (oedema)
Maltese: • nefħa (edima)
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 darba kuljum kien mqabbel ma' enoxaparin sodium 1 mg/kg SC darbtejn kuljum.
English: Common: post-operative haemorrhage, anaemia Uncommon: bleeding (epistaxis, gastrointestinal, haemoptysis, haematuria, haematoma) thrombocytopenia, purpura, thrombocythaemia, platelet abnormal, coagulation disorder
Maltese: Mhux komuni:telf ta' demm (epistaxis, emoptisis gastrointestinali, ematurja, ematoma) thromboċitopenja, purpura, thrombocitemja, plejtlet abnormali, mard talkoagulazzjoni
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 patients (0.0%) vs 5 pazjenti (1.2%), rispettivament].
English: This will activate the automatic needle protection system (picture F).
Maltese: Dan jattiva s-sistema awtomatika għall-protezzjoni tal-labra (figura F).
English: Glaxo Group Ltd Greenford Middlesex UB6 0NN United Kingdom
Maltese: Glaxo Group Ltd Greenford Middlesex UB6 0NN Renju Unit
English: Common: bleeding (gastrointestinal, haematuria, haematoma, epistaxis, haemoptysis, utero-vaginal haemorrhage, haemarthrosis, ocular, purpura, bruise)
Maltese: Komuni: fsada (gastro-intestinali, ematurja, ematoma, epistaxis, emoptisis, emorraġija uteruvaġinali, emartrosis, okulari, purpura, tbenġil)
English: Picture B
Maltese: Figura B
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: Fondaparinux ipprovda tnaqqis sinifikanti fir-rata ġenerali ta' VTE pparagunata ma' plaċebo [3 pazjenti (1.4 %) vs 77 pazjent (35 %) rispettivament}.
English: Incidences of bleeding events in patients receiving the recommended regimen in the treatment of DVT or PE with normal renal function, mild renal impairment, moderate renal impairment and severe renal impairment were 3.0 % (34/1132), 4.4 % (32/733), 6.6% (21/318), and 14.5 % (8/55) respectively.
Maltese: Każi ta' fsada f'pazjenti li għandhom indeboliment renali ħafif, indeboliment renali moderat u indeboliment renali sever, li jieħdu d-dożaġġ rakkomandat fi trattament ta' DVT jew PE, kienu ta' 3.0 % (34/1132), 4.4 % (32/733), 6.6% (21/318), u 14.5 % (8/55), rispettivament.
English: Quixidar
Maltese: SUQ
English: LIST OF EXCIPIENTS Also contains: sodium chloride, water for injections, hydrochloric acid, sodium hydroxide.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fiha wkoll: sodium chloride, ilma għal injezzjonijiet, hydrochloric acid, sodium hydroxide.
English: Rare: allergic reaction
Maltese: Rari:reazzjonijiet allerġiċi
English: Picture G
Maltese: Figura G
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 talkoagulazzjoni 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 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 jeħel ħafna u speċifikament ma' l- proteina antitrombin u jilħaq konċentrazzjonijiet fil-plażma li jiddependi mid-doża (98.6% sa 97.0% fil-medda ta' konċentrazzjonijiet minn 0.5 sa 2 mg/l).
English: Disposal of syringes:
Maltese: Meta tuża mediċini oħra:
English: In this study, the incidence of total VTE was 4.6% (47/1027) with fondaparinux, versus 6.1%: (62/1021) 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% (47/1027), meta mqabbel ma' 6.1% (62/1021) b' dalteparin: reduzzjoni ta' l- odds ratio [95%CI] = -25.8%
English: - hypersensitivity to the active substance or to any of the excipients - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 20 ml/min.
Maltese: - Fsada attiva klinikament sinifikanti - Endokardite batterika akuta - Indeboliment sever renali definit bi clearance tal-krejatinina ta' < 20 ml/min
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • F'żmien ta' 60 ġurnata wara li tkun tlaħqet xi mira importanti (ta' farmakoviġilanza jew ta' tnaqqis ta' riskji)
English: GlaxoSmithKline AB Tel: + 46 (0) 8 638 93 00 info.produkt@gsk.com
Maltese: Tel: + 46 (0) 8 638 93 00 info.produkt@gsk.com
English: Quixidar 5 mg/0.4 ml solution for injection.
Maltese: Quixidar 5 mg/0.4 ml soluzzjoni għal injezzjoni.
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: Major bleedings, all at surgical site and none fatal, were observed in 8 patients (2.4%) treated with fondaparinux 2.5 mg compared to 2 (0.6%) with placebo.
Maltese: Fsada maġġuri , kollha f'siti kirurġiċi u mhux fatali, kienu osservati fi 8 pazjenti (2.4 %) trattati b'fondaparinux 2.5 mg ipparagunati ma' 2 (0.6 %) bil-plaċebo.
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: Treatment with fondaparinux was demonstrated to be non-inferior to enoxaparin (VTE rates 3.9% and 4.1%, respectively).
Maltese: Intwera li t-trattament ta' fondaparinux mhux inferjur għal dak b' enoxaparin (rati ta' VTE 3.9% u 4.1%, rispettivament).
English: HOW TO STORE QUIXIDAR
Maltese: QABEL MA TUŻA QUIXIDAR
English: Sodium hydroxide
Maltese: Fondaparinux sodium
English: Fondaparinux is contra-indicated in severe renal impairment (creatinine clearance <30 ml/min) and should be used with caution in patients with moderate renal impairment (creatinine clearance 30-50 ml/min).
Maltese: Fondaparinux huwa kontra-indikat f'indeboliment renali sever (clearance tal- krejatinina < 30ml/min) u jrid jintuża b'attenzjoni f' pazjenti f'indeboliment renali moderat (clearance tal- krejatinina 30-50 ml/min).
English: Suomi/Finland Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Maltese: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
English: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom Manufacturer:
Maltese: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Renju Unit L-manifattur:
English: GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900
Maltese: GlaxoSmithKline Eesti OÜ Tel: + 372 6676 900 estonia@gsk.com
English: There are different syringes for the 2.5 mg and 1.5 mg doses.
Maltese: Hemm siringi differenti għad-dożi ta' 2.5mg u 1.5mg.
English: BATCH NUMBER Batch {number}
Maltese: NUMRU TAL-LOTT Lott [numru]
English: It is available in packs of 2, 7, 10 and 20 pre-filled syringes (not all pack sizes may be marketed).
Maltese: Huwa disponibbli f'pakketti ta' 2, 7, 10 u 20 siringi mimlija lesti (mhux id-daqsijiet kollha talpakketti jistgħu jkunu għall-skop kummerċjali).
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: At the 10 mg dose used in interaction studies, fondaparinux did not significantly influence the anticoagulation activity (INR) of warfarin.
Maltese: Fid-doża ta' 10 mg użata f' studji ta' interazzjoni, fondaparinux ma kellux effett sinifikanti fuq l-attivita` antikoagulanti (INR) ta' warfarin.
English: Quixidar is used to:
Maltese: Quixidar jintuża:
English: Picture D
Maltese: Figura D
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 għall-kanċer (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: 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: 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 f'Jum 30 tnaqqset sinifikament minn 14.0% fuq plaċebo għal 11.3% (hazard ratio 0.80, 95% CI, 0.69.
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, 1407 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, 1407 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: In studies versus enoxaparin 40 mg once daily started 12 hours before surgery, major bleeding was observed in 2.8% of fondaparinux patients treated with the recommended dose, compared to 2.6% with enoxaparin.
Maltese: Fi studji ta' tqabbil kontra enoxaparin 40 mg darba kuljum mibdi 12-il siegħa qabel l-operazzjoni, fsada maġġuri kienet osservata f'2.8 % tal-pazjenti trattati bid-doża rakkomandata ta' fondaparinux, paragunati ma' 2.6 % b'enoxaparin.
English: Glaxo Wellcome Production 1, rue de l'Abbaye F-76960 Notre Dame de Bondeville France
Maltese: F-76960 Notre Dame de Bondeville Franza
English: 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.
Maltese: L-effetti mhux mixtieqa li ġew irrapurtati 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.
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: • if you have a risk of uncontrolled bleeding (haemorrhage) including:
Maltese: • jekk għandek riskju ta' ħruġ ta' demm (emorraġija) mhux ikkontrollat, inkluż:
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 lkażi f'pazjenti li jieħdu d-dożaġġ rakkomandat ta' UFH fit-trattament ta' PE kienu ta' 5.5%, 6.6 % and 7.4 % rispettivament.
English: • 10 mg fondaparinux sodium in 0.8 ml solution for injection
Maltese: • 10 mg ta' fondaparinux sodium f'0.8 ml ta' soluzzjoni għall-injezzjoni.
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 - 1407 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 - 1407 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: • 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 tal-krejatinina bejn 20 u 30 ml/min.
English: 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).
Maltese: 0.93, p = 0.003). 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).
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1).
Maltese: Trattament ta' anġina mhux stabbli jew infart mijokardijaku mingħajr elevazzjoni tas-segment ST (UA/NSTEMI) għal dawk il-pazjenti fejn mhux indikat trattament invasif (PCI) urġenti (< 120 minuta) (ara sezzjoni 4.4 u 5.1).
English: Over 4874 patients were studied in controlled Phase II and III clinical studies.
Maltese: Iżjed minn 4874 pazjent kienu studjati f'studji kliniċi kontrollati f' Fażi
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: 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).
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 (5000 IU) followed by a continuous IV infusion adjusted to maintain 1.5-2.5 times aPTT control value.. A total of 2184 patients were treated; for both groups, patients were treated for at least 5 days and up to 22 days (mean 7 days).
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 (5000IU) segwit minn infużjoni IV kontinwu li kien aġġustat biex jinżamm 1.5-2.5 darbiet l-valur ta' kontrol aPTT.
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 hemorrhage 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, linċidenza 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: Quixidar 7.5 mg/0.6 ml solution for injection Quixidar 10 mg/0.8 ml solution for injection Fondaparinux sodium
Maltese: 6ml soluzzjoni għall-injezzjoni Quixidar 10mg/0.8ml soluzzjoni għall-injezzjoni Fondaparinux sodium
English: • after the expiry date stated on the label and carton
Maltese: • wara d-data ta' skadenza li tidher fuq it-tabella u l-kaxxa
English: Similarly, no plasma clearance differences were observed between black and Caucasian patients undergoing orthopaedic surgery.
Maltese: Ma nstabux differenzi fil-clearance tal-plażma bejn pazjenti suwed u Kawkasi li għamlu kirurġija ortopedika.
English: Quixidar 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with an orange automatic safety system.
Maltese: Quixidar 5 mg/0.4 ml jinstab f'pakketti ta' 2, 7, 10, u 20 siringi mimlija lesti b' sistema awtomatika ta' sigurta' oranġjo.
English: • Do not inject Quixidar into muscle.
Maltese: • Tinjettax Quixidar ġo muskolu.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/005-008
Maltese: NUMRI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/206/005-008
English: Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3).
Maltese: 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).
English: - hypersensitivity to the active substance or to any of the excipients - active clinically significant bleeding - acute bacterial endocarditis - severe renal impairment defined by creatinine clearance < 30 ml/min.
Maltese: - Sensittività eċċessiva għal fondaparinux jew għal xi sustanzi mhux attivi - Fsada attiva li tkun klinikament sinifikattiva - Endokardite akuta kawżata minn batterji - Indeboliment sever tal-kliewi definit bi clearance tal-krejatinina ta' < 30 ml/min.
English: Quixidar 10 mg/0.8 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a violet automatic safety system.
Maltese: Quixidar 10 mg/0.8 ml jinstab f'pakketti ta' 2, 7, 10, u 20 siringi mimlija lesti b' sistema awtomatika ta' sigurta' vjola.
English: Prevention of Venous Thromboembolic Events (VTE) in patients 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'pazjenti 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: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilmediċini (EMEA) http://www.emea.europa.eu
English: • breathlessness
Maltese: • reazzjonijiet allerġiċi
English: • Treatment of UA/NSTEMI and STEMI - fondaparinux should not be used in patients with creatinine clearance < 20 ml/min (see section 4.3).
Maltese: • Trattament ta' UA/NSTEMI u STEMI - fondaparinux m'għandux jingħata lil pazjenti bi clearance tal-krejatinina < 20 ml/min (ara sezzjoni 4.3).
English: Other antiplatelet medicinal products (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine or clopidogrel), and NSAIDs should be used with caution.
Maltese: Mediċini oħra kontra l-plejtlets (acetylsalicylic acid, dipyridamole, sulfinpyrazone, ticlopidine jew clopidogrel), u NSAIDs għandhom jintużaw b'attenzjoni.
English: Bleeding risk is increased with concomitant administration of fondaparinux and agents that may enhance the risk of haemorrhage (see section 4.4).
Maltese: Ir-riskju ta' fsada jiżdied bl-amministrazzjoni konkomitanti ta' fondaparinux u aġenti li jistgħu jżidu r-riskju ta' emorraġija (ara sezzjoni 4.4).
English: 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.
Maltese: 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 filkuntest kirurġiku u mediku.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/009-011, 018
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/206/009-011, 018