FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study of 3235 high-risk UA/NSTEMI patients scheduled for angiography and treated with openlabel fondaparinux (OASIS 8/FUTURA), the 2026 patients indicated for PCI were randomised to receive one of two double-blind dose regimens of adjunctive UFH.
Maltese: Fi studju ta' 3235 pazjent b'riskju ogħli ta' UA/NSTEMI skedati għal anġiografija u kkurati b'fondaparinux open-label (OASIS 8/FUTURA), l-2026 pazjent indikati għal PCI kienu randomised biex jirċievu skeda waħda minn żewġ skedi ta' dożi double-blind ta' UFH miżjud mal-kura.
English: Day 30 was significantly reduced from 15% for the control group to 12.1% for the fondaparinux group (hazard ratio 0.79, 95% CI, 0.65;0.97, p = 0.023).
Maltese: 3% fuq UFH għal 11.5% b'fondaparinux (hazard ratio 0.79, 95% CI, 0.64, 0.98, p = 0.03).
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: In patients >75 years undergoing orthopaedic surgery and receiving fondaparinux 2.5 mg once daily, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients <65 years.
Maltese: F'pazjenti > 75 sena li jgħaddu minn kirurġija ortopedika, u fuq fondaparinux 2.5 mg darba kuljum, l-estimu tal-clearance tal-plażma kienu minn 1.2 sa 1.4 l-darba iżjed baxx minn dak ta' pazjenti < 65 sena.
English: Arixtra has not been tested in children and adolescents under the age of 17 years.
Maltese: Arixtra ma ġietx ittestjata fi tfal u addoloxxenti ta' taħt is-17-il sena.
English: Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery.
Maltese: It-trattament għandu jitkompla sakemm ir-riskju ta' tromboemboliżmu fil-vini jonqos, solitament sakemm il-pazjent ikun ambulanti, mill-inqas 5 sa 9 t' ijiem wara l-operazzjoni.
English: Patients were excluded if they had severe hepatic impairment, severe renal impairment (creatinine clearance <30ml/min), low body weight (<50kg), active cancer, symptomatic PE or a recent history of DVT/PE (<6 months) or superficial-vein thrombosis (<90 days), or superficial-vein thrombosis associated with sclerotherapy or a complication of an IV line, or they were at high risk of bleeding.
Maltese: Il-pazjenti kienu esklużi jekk kellhom indeboliment qawwi tal-fwied, indeboliment qawwi tal-kliewi (tneħħija tal-krejatinina <30ml/min), piż baxx tal-ġisem (<50 kg), kanċer attiv, PE sintomatika jew storja medika riċenti ta' DVT/PE (<6 xhur) jew trombożi fil-vini superfiċjali (<90 jum), jew trombożi fil-vini superfiċjali marbuta ma' skleroterapija jew li ġejja minn kumplikazzjoni ta' pajp għal ġol-vini, jew kellhom riskju kbir ta' fsada.
English: Arixtra 7.5 mg/0.6 ml solution for injection Arixtra 10 mg/0.8 ml solution for injection fondaparinux sodium
Maltese: 6ml soluzzjoni għall-injezzjoni Arixtra 10mg/0.8ml soluzzjoni għall-injezzjoni fondaparinux sodium
English: • prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness.
Maltese: • tevita l-formazzjoni ta' emboli waqt u ftit wara l-perjodu ta' mobilita` restritta minħabba mard akut.
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 tal-krejatinina ta' anqas minn 30 ml/min.
English: Arixtra 5 mg/0.4 ml is available in pack sizes of 2, 7, 10 and 20 pre-filled syringes.
Maltese: Arixtra 5 mg/0.4 ml jinstab f'pakketti ta' 2, 7, 10, u 20 siringi mimlija lesti.
English: Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Maltese: Arixtra 1.5 mg/0.3 ml soluzzjoni għall-injezzjoni, siringa mimlija lesta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.8 ml) contains 10 mg fondaparinux sodium.
Maltese: Siringa waħda mimlija lesta (0.8 ml) fiha 10 mg fondaparinux sodium.
English: • Prevention of VTE - Fondaparinux is known to be mainly excreted by the kidney.
Maltese: • Prevention of VTE - Mhux neċessarju li jsir aġġustament fid-doża ta' fondaparinux.
English: Plasma concentrations of half the mean Cmax values are reached 25 minutes post-dosing.
Maltese: Konċentrazzjonijiet fil-plażma ta' nofs il-medja tal-valuri Cmax jintlaħqu 25 minuta wara ddoża.
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 randomised double-blind, 737 pazjent ġew trattati b'fondaparinux 2.5 mg darba kuljum għal 7 +/- 1 ġranet wara kirurġija għal frattura fil-ġenb.
English: Rare: other bleeding (hepatic, retroperitoneal, intracranial/intracerebral), thrombocythaemia
Maltese: intrakranja/intraċerebrali), tromboċitemija
English: In elderly healthy subjects, pharmacokinetics of fondaparinux is 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: CLINICAL PARTICULARS
Maltese: Studji klinici
English: After an initial 10 mg daily dose, a reduction of the daily dose to 7.5 mg may be considered, based on pharmacokinetic modelling (see section 4.2).
Maltese: Wara doża fil-bidu ta' 10 mg kuljum, tista' tiġi kunsidrata meta bażata fuq mudell farmakokinetiku, tnaqqis fid-doża għal 7.5 mg kuljum, (ara sezzjoni 4.2).
English: Do not administer intramuscularly.
Maltese: Ilma għal injezzjonijiet
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 talkrejatinina < 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 huwa amministrat permezz ta' injezzjoni subkutanja fonda waqt li l-pazjent ikun mindud.
English: All patients received standard medical treatment for UA/NSTEMI, with 34% of patients undergoing PCI and 9% undergoing CABG.
Maltese: Il-pazjenti kollha ġew mogħtija trattament mediku normali għal UA/NSTEMI, bi 34% minnhom operati b'PCI u 9% minnhom b'CABG.
English: The adverse event profile reported in the ACS program is consistent with the adverse drug reactions identified for VTE prophylaxis.
Maltese: Il-profil ta' effetti mhux mixtieqa li ġew irrappurtati fil-programm ACS huwa konsistenti ma' l-effetti mhux mixtieqa dentifikati għall-profilassi ta' VTE.
English: In elderly healthy subjects, pharmacokinetics of fondaparinux are linear in the range of 2 to 8 mg by subcutaneous route.
Maltese: F'suġġetti anzjani f'saħħithom, il-farmakokinetiċi ta' fondaparinux huma linejari ta' bejn 2 sa 8 mg mogħtija b'mod subkutanju.
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 tal ġenb.
English: Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Maltese: Għalkemm mhux evalwati totalment, m'hemm l-ebda evidenza ta' metaboliżmu ta' fondaparinux u b'mod partikulari ma hemm l-ebda evidenza ta' formazzjoni ta' metaboli attivi.
English: Approximately 40% and 14% of patients had mild (creatinine clearance ≥50 to <80 ml/min) or moderate (creatinine clearance ≥30 to <50 ml/min) renal impairment, respectively.
Maltese: Madwar 40% u 14% talpazjenti kellhom, rispettivament, indeboliment ħafif tal-kliewi (tneħħija ta' kreatinina ≥50 sa <80 ml/min) jew indeboliment moderat (tneħħija ta' kreatinina ≥30 sa <50 ml/min).
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 % (34/1,132), 4.4 % (32/733), 6.6% (21/318), and 14.5 % (8/55) respectively.
Maltese: PE, kienu ta' 3.0 % (34/1,132), 4.4 % (32/733), 6.6% (21/318), u 14.5 % (8/55), rispettivament.
English: Animal studies are insufficient with respect to effects on toxicity to reproduction because of limited exposure.
Maltese: Studji fuq lannimali huma insuffiċjenti rigward l-effetti tossiku fuq is-sistema riproduttiva minħabba espożizzjoni limitata.
English: In the Phase III study in STEMI patients, the most commonly reported non-bleeding adverse events (reported in at least 1% of subjects on fondaparinux) were atrial fibrillation, pyrexia, chest pain, headache, ventricular tachycardia, vomiting, and hypotension.
Maltese: III STEMI, l-effetti mhux mixtieqa li mhumiex relatati ma fsada, li ġew irrappurtati l-iżjed komunement (irrappurtati f'mill-anqas 1% ta' suġġetti fuq fondaparinux) kienu fibrillazzjoni ta' l-atriju, deni, uġigħ fis-sider, uġigħ ta' ras, takikardija ventrikulari, remettar u pressjoni baxxa.
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: 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: TVR - target vessel revascularization
Maltese: TVR - rivaskularizzazzjoni tal-arterja jew il-vina fil-mira
English: In patients initially not reperfused, the incidence of severe haemorrhage was 1.2% for fondaparinux vs 1.5% for controls.
Maltese: F'pazjenti li għall-bidu ma kienux riperfużi, l-inċidenza ta' emorraġija qawwija kienet ta' 1.2% f'dawk fuq fondaparinux kontra 1.5% f'dawk taħt kontroll.
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: 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: Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (See section 4.3).
Maltese: Fondaparinux huwa kontra-indikat f'indeboliment renali sever (clearance tal- krejatinina < 30ml/min)
English: OTHER SPECIAL WARNING(S), IF NECESSARY Body weight 50-100 kg
Maltese: OĦRA, JEKK MEĦTIEĠA Piż tal-ġisem 50-100 kg
English: • syringe with orange plunger and a manual safety system.
Maltese: • siringa bi planġer oranġjo u b'sistema manwali ta' sigurtà
English: The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited.
Maltese: Il-tul medju tat-trattament fi studji kliniċi kien ta' 7 t'ijiem u l-esperjenza klinika mit-trattament għal aktar minn 10 t'ijiem hija limitata.
English: Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe.
Maltese: Arixtra 7.5 mg/0.6 ml soluzzjoni għall-injezzjoni, siringa mimlija lesta
English: In patients given a thrombolytic, severe haemorrhage occurred in 1.3% of the fondaparinux patients and in 2.0% of controls.
Maltese: F'pazjenti li ħadu sustanza trombolitika, emorraġija qawwija seħħet f'1.3% talpazjenti b'fondaparinux u f'2.0% f'pazjenti taħt kontroll.
English: • coughing
Maltese: • sogħla
English: Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Maltese: Siringa waħda mimlija lesta (0.3 ml) fiha 1.5 mg fondaparinux sodium.
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: Renal impairment - Fondaparinux should be used with caution in patients with moderate renal impairment (see section 4.4).
Maltese: Indeboliment tal-kliewi - Għandha tittieħed attenzjoni bl-użu ta' fondaparinux f'pazjenti b'indeboliment moderat tal-kliewi (ara sezzjoni 4.4).
English: Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe.
Maltese: Arixtra 10 mg/0.8 ml soluzzjoni għall-injezzjoni, siringa mimlija lesta
English: • Prevention of VTE - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Maltese: • Prevenzjoni ta' VTE - Fondaparinux m'għandux jingħata lil pazjenti bi clearance tal krejatinina < 20 ml/min (ara sezzjoni 4.3).
English: Prevention of Venous Thromboembolic Events (VTE) in adult 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 adulti 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: 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 ġol vina għandha ssir minn ġo linja intravenuża diġà eżistenti, direttament jew permezz ta' volum żgħir (25 ml jew 50 ml) ta' 0.9% saline f'borża żgħira.
English: Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Maltese: Arixtra 2.5 mg/0.5 ml soluzzjoni għall-injezzjoni, siringa mimlija lesta.
English: The elderly population is at increased risk of bleeding.
Maltese: Il-popolazzjoni anzjana għandha riskju akbar ta' fsada.
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,
English: • dizziness
Maltese: dijareja
English: Uncommon: oedema, oedema peripheral, fever, wound secretion
Maltese: Mhux komuni: edema, edema periferali, deni, nixxija mill-ferita
English: The mean age of the patients was 67 years, and approximately 60% were at least 65 years old.
Maltese: L-eta' medja tal-pazjenti kienet ta' 67 sena, u madwar 60% kellhom mill-inqas 65 sena.
English: • syringe with a orange plunger and an automatic safety system
Maltese: • siringa oranġjo b'sistema awtomatika ta' sigurtà..
English: As renal function generally decreases with age, elderly patients may show reduced elimination and increased exposure of fondaparinux (see section 5.2).
Maltese: Minħabba li l-funzjoni renali ġeneralment tonqos bl-eta`, pazjenti anzjani jista' jkollhom tnaqqis fl-eliminazzjoni u espożizzjoni akbar għal fondaparinux (ara sezzjoni 5.2).
English: Elimination of fondaparinux decreases with weight.
Maltese: L-eliminazzjoni ta' fondaparinux tonqos mal-piż.
English: Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Maltese: Piż tal-ġisem - Il-clearance tal-plażma ta' fondaparinux jiżdied mall-piż (żieda ta' 9% kull 10 kg)
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: fsada maġġuri kienet osservata f'2.8 % tal-pazjenti trattati bid-doża rakkomandata ta' fondaparinux,
English: Disposal of syringes:
Maltese: Partijiet mis-siringi:
English: • syringe with a magenta plunger and an automatic safety system
Maltese: • siringa ta' kulur maġenta b' sistema awtomatika ta' sigurtà.
English: No dosage reduction is required for patients with mild renal impairment (creatinine clearance >50 ml/min).
Maltese: M'hemmx bżonn li titnaqqas id-doża f'pazjenti b'indeboliment renali ħafif (clearance tal-krejatinina >50 ml/min).
English: • For prevention of VTE - Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Maltese: • Għall-prevenzjoni ta' VTE - Aġenti li jistgħu jżidu r-riskju ta' emorraġija m'għandhomx jiġu amministrati flimkien ma' fondaparinux.
English: • 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: • 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: In a double-blind clinical study, 2,927 patients were randomised to receive fondaparinux 2.5mg once daily or dalteparin 5,000 IU once daily, with one 2,500 IU preoperative injection and a first 2,500 IU post-operative injection, for 7+2 days.
Maltese: fondaparinux 2.5 mg darba kuljum jew dalteparin 5,000 IU darba kuljum, b' injezzjoni waħda qabel loperazzjoni ta' 2,500 IU u l-ewwel injezzjoni ta' 2,500 IU wara l-operazzjoni, għal 7 ± 2 ġranet.
English: There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/min).
Maltese: M'hemmx esperjenza fis-sub-grupp ta' pazjenti li għandhom kemm piż għoli (>100 kg), kif ukoll indeboliment renali moderat (clearance tal- krejatinina 30-50 ml/min).
English: The majority (70/80) of the recorded VTE events were venographically detected non-symptomatic cases of DVT.
Maltese: (70/80) ta' l-eventi VTE reġistrati kienu każijiet ta' DVT mingħajr sintomi li kienu skoperti b'eżami venografiku.
English: At the 10 mg dose used in the interaction studies, fondaparinux did not influence the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Maltese: Fid-doża ta' fondaparinux (10 mg) li ntużat fl-istudji ta' interazzjoni, fondaparinux ma kellu ebda effett fuq il-ħin biex jieqaf id-demm (bleeding time) waqt trattament b' acetylsalicylic acid jew piroxicam, u lanqas fuq il-farmakokinetika ta' digoxin fi stat fiss.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Maltese: Siringa waħda mimlija lesta (0.6 ml) fiha 7.5 mg fondaparinux sodium.
English: Fondaparinux should be used with caution in patients who have an increased risk of haemorrhage, such as those with congenital or acquired bleeding disorders (e.g. platelet count <50,000/mm3), active ulcerative gastrointestinal disease and recent intracranial haemorrhage or shortly after brain, spinal or ophthalmic surgery and in special patient groups as outlined below.
Maltese: Fondaparinux għandu jintuża b'attenzjoni f'pazjenti b'riskju ogħla ta' emorraġija, bħal dawk b'mard ta' fsada kemm konġenitali jew akkwistati (es. għadd ta' plejtlets < 50,000/ mm3), mard gastrointestinali ulċerattiv attiv u emorraġija riċenti fil-kranju jew ftit wara kirurgija fil-moħħ, is-sinsla jew l-għajnejn u fi gruppi speċjali ta' pazjenti li jissemmew hawn taħt.
English: Minor gastrointestinal bleeding was reported in another patient on day 5 of therapy which resulted in temporary discontinuation of fondaparinux.
Maltese: Fsada gastrointestinali ħafifa kienet irrappuratata f'pazjent ieħor fil-jum 5 tat terapija li wassal għal twaqqif temporanju ta' fondaparinux.
English: Following once daily subcutaneous dosing, steady state of plasma levels is obtained after 3 to 4 days with a 1.3-fold increase in Cmax and AUC.
Maltese: Meta tibda tittieħed id- doża darba kuljum, livelli fissi fil-plażma jintlaħqu wara 3 sa 4 t'ijiem, b'żieda ta' 1.3 darba iżjed f' Cmax u AUC.
English: Fondaparinux does not inactivate thrombin (activated Factor II) and has no effects on platelets.
Maltese: Fondaparinux ma' jinattivax trombin (Fattur II
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Maltese: Siringa waħda mimlija lesta (0.4 ml) fiha 5 mg fondaparinux sodium.
English: Rare: chest pain, fatigue, hot flushes, leg pain, oedema genital, flushing, syncope
Maltese: Rari: anzjeta`, nagħas, vertigo, sturdament, uġigħ ta' ras, konfużjoni
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,
English: Over 4,874 patients were studied in controlled Phase II and III clinical studies.
Maltese: Iżjed minn 4,874 pazjent kienu studjati f'studji kliniċi kontrollati f' Fażi
English: In patients >75 years undergoing orthopaedic surgery, the estimated plasma clearance was 1.2 to 1.4 times lower than in patients <65 years.
Maltese: F'pazjenti > 75 sena li jgħaddu minn kirurġija ortopedika, il-clearance tal-plażma ġiet stmata bħala 1.2 sa 1.4 drabi iktar baxxa milli f'pazjenti ta' < 65 sena.
English: Fondaparinux neither influenced the INR activity of warfarin, nor the bleeding time under acetylsalicylic acid or piroxicam treatment, nor the pharmacokinetics of digoxin at steady state.
Maltese: Fondaparinux lanqas ma influwenza l-attivita` INR ta' warfarin, lanqas il-ħin ta' fsada taħt acetylsalicylic acid jew trattament ta' piroxicam, lanqas ilfarmakokinetiċi ta' digoxin fi stat fiss.
English: • The active substance is 1.5 mg fondaparinux sodium in 0.3 ml solution for injection
Maltese: • Is-sustanza attiva hija 2.5 mg ta' fondaparinux sodium f'0.5ml ta' soluzzjoni għall-injezzjoni.
English: Rare: rash erythematous, pruritus
Maltese: • ħass ħażin jew sturdament, pressjoni baxxa
English: The safety and efficacy of 1.5 mg has not been studied.
Maltese: Is-sigurtà u l-effikaċja ta' doża ta' 1.5 mg ma ġietx studjata.
English: EU/1/02/206/031 - 2 pre-filled syringes with a manual safety system EU/1/02/206/032 - 10 pre-filled syringes with a manual safety system EU/1/02/206/035 - 20 pre-filled syringes with a manual safety system
Maltese: EU/1/02/206/031 - 2 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/032 - 10 siringi mimlijin lesti b'sistema manwali ta' sigurtà EU/1/02/206/035 - 20 siringi mimlijin lesti b'sistema manwali ta' sigurtà
English: Uncommon: dyspnoea
Maltese: Mhux komuni: anemija