FrancophonIA/ELRC3.0 huggingface dataset:
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (ATIII) 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: In severe renal impairment (creatinine clearance <30 ml/min), plasma clearance is approximately 5 times lower than in normal renal function.
Maltese: F'indeboliment renali serju (clearance tal-krejatinina < 30 ml/min), il-clearance fil-plażma huwa bejn wieħed u ieħor 5 darbiet izjed baxx minn dak f' funzjoni renali normali.
English: Fondaparinux must not be administered intramuscularly.
Maltese: Fondaparinux m'għandux jiġi amministrat b'mod intramuskolari.
English: Treatment with fondaparinux was demonstrated to be non-inferior to unfractionated heparin (VTE rates 3.8% and 5.0%, respectively).
Maltese: Intwera li t-trattament ta' fondaparinux mhux inferjur għal dak b' enoxaparin (rati ta' VTE 3.8% u 5.0%, rispettivament).
English: Marketing Authorization Holder: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom
Maltese: Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, Renju Unit
English: By binding selectively to antithrombin, fondaparinux potentiates (about 300 times) the innate neutralization of Factor Xa by antithrombin.
Maltese: Meta fondaparinux jeħel seletivament ma' antitrombin, huwa jsaħħaħ (għal madwar 300 darba) in-newtralizzazzjoni naturali ta' Fattur Xa permezz ta' antitrombin.
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; these adverse reactions should be interpreted within the surgical and medical context.
Maltese: 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.
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 12000 patients with STEMI.
Maltese: OASIS 6 kien studju double blind, mhux bażat fuq xi għażla ppjanata, li jassessja s-sigurta' u leffikaċja ta' 2.5 mg fondaparinux kuljum, kontra kura normali (plaċebo 47% jew UFH(53%)) f'madwar 12000 pazjent bi STEMI.
English: During treatment of VTE, 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 linformazzjoni mogħtija f'sezzjoni 4.5.
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: Paediatric patients - Fondaparinux has not been investigated in this population.
Maltese: Pazjenti pedjatriċi - Fondaparinux ma ġiex investigat fuq din il-popolazzjoni.
English: Quixidar is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a blue automatic safety system.
Maltese: Quixidar huwa disponibbli f'daqsijiet ta' pakketti ta' 2, 7, 10 u 20 siringi mimlija lesti b'sistema ta' sikurezza awtomatika blu.
English: • The active substance is 2.5 mg fondaparinux sodium in 0.5 ml solution for injection
Maltese: • Is-sustanza attiva hija 2.5 mg ta' fondaparinux sodium f'0.5ml ta' soluzzjoni għall-injezzjoni.
English: Hepatic impairment - Fondaparinux pharmacokinetics has not been evaluated in hepatic impairment.
Maltese: Indeboliment tal-fwied - Il-farmakokinetika ta' fondaparinux ma ġietx evalwata f'indeboliment talfwied.
English: 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.
Maltese: 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.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/001-004
Maltese: NUMRUI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/206/001-004
English: 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 flarterja koronarja (CABG), fejn possibbli fondaparinux m'għandux jingħata fl-24 siegħa ta' qabel ilkirurġija u jista jerġa jinbeda 48 siegħa wara l-operazzjoni.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Siringa waħda mimlija lesta (0.8 ml) fiha 10 mg fondaparinux sodium.
English: There are limited clinical data available from patients with creatinine clearance less than 30 ml/min.
Maltese: Hemm tagħrif kliniku limitat fuq pazjenti bi clearance talkrejatinina ta' anqas minn 30 ml/min.
English: ANNEX II A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: DETENTUR(I) TA' L-AWTORIZZAZZJONI TALMANIFATTURA RESPONSABBLI
English: 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).
Maltese: 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.
English: STEP BY STEP GUIDE TO USING QUIXIDAR
Maltese: GWIDA PASS-PASS BIEX TUŻA QUIXIDAR
English: These may affect up to 1 in 1000 people treated with Quixidar.
Maltese: Dawn jistgħu jaffettwaw sa 1 kull 1000 persuna trattati bi Quixidar:
English: Renal impairment - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Maltese: Indeboliment renali - Fondaparinux m'għandux jingħata lil pazjenti bi clearance tal-krejatinina < 20 ml/min (ara sezzjoni 4.3).
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/012-014, 019
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/206/012-014, 019
English: Renal impairment Fondaparinux is known to be mainly excreted by the kidney.
Maltese: Indeboliment renali Fondaparinux hu magħruf li jiġi mneħħi prinċipalment mill-kliewi.
English: Quixidar 7.5 mg/0.6 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes with a magenta automatic safety system.
Maltese: Quixidar 7.5 mg/0.6 ml jinstab f'pakketti ta' 2, 7, 10, u 20 siringi mimlija lesti b' sistema awtomatika ta' sigurta' ta' kulur maġenta.
English: MedDRA
Maltese: Sentejn
English: • flushing
Maltese: • sturdament
English: In elderly healthy subjects, pharmacokinetics of fondaparinux are linear in the range of 2 to 8 mg by subcutaneous route.
Maltese: F'pazjenti anzjani f'saħħithom, il-farmakokinetika ta' fondaparinux b'injezzjoni subkutanja hija linejari fil-medda ta' 2 sa 8 mg.
English: 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.
Maltese: 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 għallprevenzjoni ta'eventi tromboemboliċi fil-vini (VTE), jiġifieri trombożi fil-vini fondi prossimali u tattruf 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 talġenb.
English: Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Maltese: Piż tal-ġisem - Clearance tal-plażma b'fondaparinux tiżdied mal-piż tal-ġisem (9 % żieda għal kull 10 kg).
English: Body weight above 100 kg
Maltese: Il fuq minn 100 kg
English: Intravenous administration should be through an existing intravenous line either directly or using a small volume (25 or 50ml) 0.9% saline minibag.
Maltese: L-amministrazzjoni ġolvina 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.
English: 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 (see section 5.1).
Maltese: Il-prevenzjoni ta' Każi Trombo-emboliċi Venużi (VTE) f'pazjenti 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: The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due to a reduction of asymptomatic distal DVT.
Maltese: Iddifferenza fir- rati ta' VTE totali bejn il-gruppi ta' trattament, li ma kienx statistikament sinifikanti, kien l-biċċa l-kbira minħabba tnaqqis f' DVT fit-truf mhux sintomatiku.
English: 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).
Maltese: F'pazjenti bi clearance tal-krejatinina ta' bejn 20 sa 50 ml/min, iddoża ta' fondaparinux għandha titnaqqas għal 1.5 mg darba kuljum (ara sezzjonijiet 4.4 u 5.2).
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.2 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: L-MAH jimpenja ruħu li jwettaq l-istudji u l-attivitajiet addizzjonali ta' farmakoviġilanza dettaljati fil-Pjan ta' Farmakoviġilanza, kif miftiehem fil-verżjoni 1.2 tal-Pjan dwar il-Maniġġjar ta' Riskju (RMP) preżentat fit-Taqsima 1.8.2 ta' l-Applikazzjoni għall-Awtorizzazzjoni għat-Tqegħid fis-Suq u fl-aġġornamenti sussegwenti tal-RMP mifthema mas-CHMP.
English: Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (See section 4.3).
Maltese: Fondaparinux m'għandux jintuża f'pazjenti b'indeboliment sever tal-kliewi (clearance tal-krejatinina < 30ml/min) (ara sezzjoni 4.3).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.3 ml) contains 1.5 mg fondaparinux sodium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Siringa waħda mimlija lesta (0.3 ml) fiha 1.5 mg fondaparinux sodium.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Siringa waħda mimlija lesta (0.6 ml) fiha 7.5 mg fondaparinux sodium.
English: The mean age of the patients was 61 years, and approximately 40% were at least 65 years old.
Maltese: L-eta' medja talpazjenti kienet ta' 61 sena, u madwar 40% kellhom għall-inqas 65 sena.
English: Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease.
Maltese: Il-prevenzjoni ta' Każi Trombo-emboliċi Venużi (VTE) f' pazjenti mediċi li huma meqjusa f'riskju għoli ta' VTE u li huma immobili minħabba mard akut bħal insuffiċienza kardijaka u/jew mard respiratorju akut, u/ jew mard akut infettiv jew ta' infjammazzjoni.
English: EU/1/02/207/005- 2 pre-filled syringes EU/1/02/207/006 - 7 pre-filled syringes EU/1/02/207/007 - 10 pre-filled syringes EU/1/02/207/008 - 20 pre-filled syringes
Maltese: EU/1/02/206/005 - 2 siringi mimlija lesti EU/1/02/206/006 - 7 siringi mimlija lesti EU/1/02/206/007 - 10 siringi mimlija lesti EU/1/02/206/008 - 20 siringa mimlija lesta
English: 3 Plunger 4 Finger-grip 5 Security sleeve Syringe BEFORE USE
Maltese: Qabel ma tuża Quixidar 3. Kif għandek tuża Quixidar 4.
English: Hydrochloric acid
Maltese: Indeboliment epatiku qawwi
English: Undesirable effects in medical patients
Maltese: Effetti mhux mixtieqa f'pazjenti mediċi
English: There are limited data on the use of UFH during non-primary PCI in patients treated with fondaparinux (see section 5.1).
Maltese: Hemm tagħrif limitat dwar l-użu ta' UFH waqt PCI mhux primarju f'pazjenti li qed jirċievu trattament b' fondaparinux (ara sezzjoni 5.1).
English: The duration of treatment should not exceed that evaluated during clinical trial (mean 7 days) (see sections 4.2, 4.3 and 5.2).
Maltese: It-tul tat-trattament m' għandux jiżboq dak studjat waqt il-prova klinika (medda ta' 7 t'ijiem) (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A).
Maltese: Agħżel post fil-parti t'isfel ta' l-istonku, ta' l-inqas 5 cm miżżokra (figura A).
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: Cmax (mg/l) - 0.50 (32 %), Cmin (mg/l) - 0.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Maltese: Kull siringa mimlija lesta (0.3 ml) fiha 1.5 mg fondaparinux sodium.
English: The majority (70/80) of the recorded VTE events were venographically detected non-symptomatic cases of DVT.
Maltese: Ilmaġġoranza (70/80) ta' l-eventi VTE reġistrati kienu każijiet ta' DVT mingħajr sintomi li kienu skoperti b'eżami venografiku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Siringa waħda mimlija lesta (0.4 ml) fiha 5 mg fondaparinux sodium.
English: EU/1/02/207/015 - 2 pre-filled syringes EU/1/02/207/016 - 7 pre-filled syringes EU/1/02/207/017 - 10 pre-filled syringes EU/1/02/207/020 - 20 pre-filled syringe
Maltese: EU/1/02/206/015 - 2 siringi mimlija lesti EU/1/02/206/016 - 7 siringi mimlija lesti EU/1/02/206/017 - 10 siringi mimlija lesti EU/1/02/206/020 - 20 siringa mimlija lesta
English: 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).
Maltese: 3% fuq UFH għal 11.5% b'fondaparinux (hazard ratio 0.79, 95% CI, 0.64, 0.98, p = 0.03).
English: For treatment of UA/NSTEMI and STEMI, fondaparinux should be used with caution in patients who are being treated concomitantly with other agents that increase the risk of haemorrhage (such as GPIIb/IIIa inhibitors or thrombolytics).
Maltese: Fit-trattament ta' UA/NSTEMI u STEMI, fondaparinux għandu jintuża b'kawtela f'pazjenti li qed jirċievu fl-istess ħin aġenti oħra li jżidu r-riskju ta' emorraġija (bħal inibituri GP IIb/IIIa jew trombolitiċi).
English: NAME OF THE MEDICINAL PRODUCT Quixidar 10 mg/0.8 ml solution for injection, pre-filled syringe.
Maltese: Quixidar 10 mg/0.8 ml soluzzjoni għal injezzjoni.
English: EU/1/02/207/012- 2 pre-filled syringes EU/1/02/207/013 - 7 pre-filled syringes EU/1/02/207/014 - 10 pre-filled syringes EU/1/02/207/019 - 20 pre-filled syringe
Maltese: EU/1/02/206/012 - 2 siringi mimlija lesti EU/1/02/206/013 - 7 siringi mimlija lesti EU/1/02/206/014 - 10 siringi mimlija lesti EU/1/02/206/019 - 20 siringa mimlija lesta
English: Take special care with Quixidar:
Maltese: Jekk tinsa tuża Quixidar:
English: For patients receiving primary PCI, the incidence of severe haemorrhage was 1.0% for fondaparinux and 0.4% for controls.
Maltese: 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.
English: Patients with body weight <50 kg are at increased risk of bleeding.
Maltese: Pazjenti li għandhom piż < 50 kg għandhom riskju ikbar ta' fsada.
English: EXPIRY DATE EXP {month/year}
Maltese: DATA META JISKADI JIS [xahar/sena]
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.5 ml) contains 2.5 mg fondaparinux sodium.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Siringa waħda mimlija lesta (0.5 ml) fiha 2.5 mg fondaparinux sodium.
English: If you inject too much Quixidar
Maltese: X'fih Quixidar
English: EU/1/02/207/001 - 2 pre-filled syringes EU/1/02/207/002 - 7 pre-filled syringes EU/1/02/207/003 - 10 pre-filled syringes EU/1/02/207/004 - 20 pre-filled syringes
Maltese: EU/1/02/206/001 - 2 siringi mimlija lesti EU/1/02/206/002 - 7 siringi mimlija lesti EU/1/02/206/003 - 10 siringi mimlija lesti EU/1/02/206/004 - 20 siringa mimlija lesta
English: NAME OF THE MEDICINAL PRODUCT Quixidar 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Maltese: Quixidar 1.5 mg/0.3 ml soluzzjoni għall-injezzjoni, siringa mimlija lesta.
English: Mean (CV%) steady state pharmacokinetic parameters estimates of fondaparinux in patients undergoing hip replacement surgery receiving fondaparinux 2.5 mg once daily are: Cmax (mg/l) - 0.39 (31%), Tmax (h) - 2.8 (18%) and Cmin (mg/l) -0.14 (56%).
Maltese: Cmax (mg/l) - 0.39 (31 %), Tmax (h) - 2.8 (18 %) u Cmin (mg/l) -0.14 (56 %).
English: Some other medicines may affect the way that Quixidar works or be affected by Quixidar.
Maltese: It-treddigħ mhux rakkomandat waqt trattament b' Quixidar.
English: 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).
Maltese: Jekk għandu jsir intervent koronarju minn ġol-ġilda (PCI) fuq pazjent, għandha tiġi amministrata leparina 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).
English: Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure.
Maltese: Studji fuq l-annimali huma insuffiċjenti rigward l-effetti tossiku fuq is-sistema riproduttiva minħabba espożizzjoni limitata.
English: MARKETING AUTHORISATION NUMBERS EU/1/02/207/015-017, 020
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/206/015-017, 020
English: The antithrombotic activity of fondaparinux is the result of antithrombin III (antithrombin) mediated selective inhibition of Factor Xa.
Maltese: L-attivita` kontra t-trombożi ta' fondaparinux huwa riżultat ta' l-inibizzjoni selettiva ta' Fattur Xa medjat minn antitrombin III (antitrombin).
English: EU/1/02/207/009- 2 pre-filled syringes EU/1/02/207//010 - 7 pre-filled syringes EU/1/02/207/011 - 10 pre-filled syringes EU/1/02/207/018 - 20 pre-filled syringe
Maltese: EU/1/02/206/009 - 2 siringi mimlija lesti EU/1/02/206/010 - 7 siringi mimlija lesti EU/1/02/206/011 - 10 siringi mimlija lesti EU/1/02/206/018 - 20 siringa mimlija lesta
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Maltese: Kull siringa mimlija lesta (0.5 ml) fiha 2.5 mg fondaparinux sodium.
English: The needle protection system of the Quixidar pre-filled syringe has been designed with an automatic safety system to protect from needle stick injuries following injection.
Maltese: Is-sistema ta' protezzjoni tal-labra tas-siringi mimlija lesti Quixidar giet diżinjata b'sistema ta' sikurezza awtomatika biex tipproteġi minn feriti bil-labra wara l-injezzjoni.
English: Uncommon: pain, oedema, Rare: reaction at injection site
Maltese: Mhux komuni: uġigħ, edema Rari: reazzjoni fil-post ta' injezzjoni
English: The safety of fondaparinux has been evaluated in 2,517 patients treated for Venous ThromboEmbolism and treated with fondaparinux for an average of 7 days.
Maltese: Is-sigurta' ta' fondaparinux 2.5 mg ġiet evalwata f'2,517 pazjent li kienu fuq trattament b' fondaparinux għal medja ta' 7 t'ijiem għal Trombo-Emboliżmu Venuż.
English: Gastrointestinal disorders gastritis, constipation, diarrhoea
Maltese: Disturbi vaskulari Disturbi respiratorji, toraċiċi u medjastinali
English: 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: Pazjenti bi clearance talkrejatinina 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: 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.
Maltese: 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.
English: 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.
Maltese: 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.
English: • prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness.
Maltese: • jevita l-formazzjoni ta' emboli waqt u ftit wara l-perjodu ta' mobilita` restritta minħabba mard akut.
English: Following once daily dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC.
Maltese: 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.
English: NAME OF THE MEDICINAL PRODUCT Quixidar 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Maltese: Quixidar 2.5 mg/0.5 ml soluzzjoni għal injezzjoni.
English: A total of 2192 patients were treated; for both groups, patients were treated for at least 5 days and up to 26 days (mean 7 days).
Maltese: Total ta' 2192 pazjent kienu trattati; fiż-żewgt gruppi, pazjenti kienu trattati għal mill-inqas 5 t'ijiem u għal mhux iżjed minn 26 ġurnata (medja ta' 7 t'ijiem).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quixidar 2.5 mg/0.5 ml injection fondaparinux Na
Maltese: U MNEJN GĦANDU JINGĦATA Quixidar 2.5 mg/0.5 ml soluzzjoni għall-injezzjoni fondaparinux Na
English: • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
Maltese: • Is-sustanza attiva hija 1.5 mg ta' fondaparinux sodium f'0.