FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary analysis and results for ACUITY at 30-days and 1 year for the overall (ITT) population and for the patients that received acetylsalicylic acid and clopidogrel as per protocol (pre-angiography or pre-PCI) are shown in Tables 3 and 4.
Maltese: L-analiżi primarja u r-riżultati għal ACUITY wara 30 jum u wara sena għall-popolazzjoni totali (ITT) u għall-pazjenti li rċevew acetylsalicylic acid u klopidogrel skond il-protokoll (pre-anġjografija jew pre-PCI) huma murija fit-Tabelli 3 u 4.
English: Minor bleeding occurred very commonly (1/10) and major bleeding occurred commonly (1/100 and <1/10).
Maltese: Fsada minuri seħħet b'mod komuni ħafna (1/10) u fsada maġġuri seħħet b'mod komuni (1/100 u <1/10).
English: Catheter thrombosis, Vascular pseudoaneurysm
Maltese: KIF GĦANDEK TUŻA ANGIOX
English: Clinical efficacy and safety
Maltese: Effikaċja klinika u sigurta`
English: Thrombin plays a central role in the thrombotic process, acting to cleave fibrinogen into fibrin monomers and to activate Factor XIII to Factor XIIIa, allowing fibrin to develop a covalently crosslinked framework that stabilises the thrombus.
Maltese: It-thrombin għandu rwol ċentrali fil-proċess trombotiku, billi jaqsam il-fibrinoġen f'monomeri talfibrin u jattiva l-Fattur XIII għall-Fattur XIIIa, u hekk jippermetti l-fibrin jiżviluppa qafas cross-linked b'mod kovalenti li jistabbilizza t-thrombus.
English: Combined use of anti-coagulant medicinal products can be expected to increase the risk of bleeding (see section 4.5).
Maltese: Bl-użu kkombinat ta' prodotti mediċinali anti-koagulanti jista' jkun mistenni li jiżdid ir-riskju ta' fsada (ara sezzjoni 4.5).
English: Angiox 250 mg powder for concentrate for solution for injection or infusion bivalirudin
Maltese: Angiox 250 mg trab għal konċentrat għal soluzzjoni għal injezzjoni jew infużjoni bivalirudin
English: Thus, bivalirudin initially acts as a complete non-competitive inhibitor of thrombin, but transitions over time to become a competitive inhibitor enabling initially inhibited thrombin molecules to interact with other clotting substrates and to coagulation if required.
Maltese: Għalhekk, bivalirudin għall-ewwel jaġixxi kompletament bħala inibitur mhux kompetittiv tat-thrombin, iżda maż-żmien jinbidel biex isir inibitur kompetittiv li jippermetti molekuli inizjalment inibiti tat-thrombin li jinteraġixxu ma' sottostrati oħra ta' koagulazzjoni u jikkoagulaw jekk ikun meħtieġ.
English: • The most frequent serious and fatal adverse reactions are major haemorrhage (access site and non access-site bleeding, including intracranial haemorrhage) and hypersensitivity, including anaphylactic shock.
Maltese: • L-iżjed reazzjonijiet avversi serji, frekwenti u fatali kienu emoraġija maġġuri (fsad fis-sit ta' aċċess u mhux fis-sit ta' aċċess, inkluż emorraġija intrakranjali) u ipersensittivita`, inkluż xokk anafillattiku.
English: Angiox is contraindicated in patients with severe renal insufficiency (GFR<30 ml/min) and also in dialysis-dependent patients (see section 4.3).
Maltese: Angiox huwa kontraindikat għall-pazjenti li għandhom insuffiċjenza severa tal-kliewi (GFR <30 ml/min) u anke f'pazjenti li huma dipendenti fuq id-dijalisi (ara s-sezzjoni 4.3).
English: • In patients receiving warfarin, INR is increased by administration of bivalirudin.
Maltese: • F'pazjenti li jirċievu warfarina, INR tiżdied b'amministrazzjoni ta' bivalirudin.
English: Five patients had a post-baseline nadir platelet count of <150,000 cells/mm
Maltese: Ħames pazjenti kellhom l-inqas għadd ta' plejtlits ta' wara l-linja bażi ta' <150,000 ċelluli/mm
English: Ear haemorrhage
Maltese: Emorraġija intrakranjali
English: Minor haemorrhage was defined as any observed bleeding event that did not meet the criteria for a major haemorrhage.
Maltese: Fsada minuri ġiet definita bħala kwalunkwe episodju osservat ta' fsada li ma jissodisfax il-kriterji għal emorraġija maġġuri.
English: Ischaemic target vessel revascularisation Stroke
Maltese: Iskemiċi Mewt kull kawża
English: Acute stent thrombosis (<24 hours) has been observed in patients with STEMI undergoing primary PCI and has been managed by Target Vessel Revascularisation (TVR) (see sections 4.8 and 5.1).
Maltese: Trombożi akuta tal-istent Trombożi akuta tal-istent (<24 siegħa) kienet osservata f'pazjenti b' STEMI sottoposti għal PCI primarju u kien immaneġġjat b' Target Vessel Revascularisation
English: Detailed information on this medicinal product is available on the web site of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu
English: The Medicines Company UK Ltd Teл.
Maltese: The Medicines Company UK Ltd Tel.
English: 6%) of bivalirudin-treated patients and in 67 (3.9%) of patients treated with heparin plus a GP IIb/IIIa inhibitor.
Maltese: Fl-istudju Horizons, tromboċitopenja kienet rrappurtata f'26 (1. 6%) ta' pazjenti trattati b'bivalirudin u f'67 (3.9%) tal-pazjenti trattati b'eparina flimkien ma' inhibitur ta' GP IIb/IIIa.
English: Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience
Maltese: Reazzjonijiet avversi għal bivalirudin mill-provi HORIZONS, ACUITY, REPLACE-2 u esperjenza ta' wara t-tqegħid fis-suq
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: The following data is based on a clinical study of bivalirudin in 6,000 patients undergoing PCI, half of whom were treated with bivalirudin (REPLACE-2).
Maltese: Id-dejta li ġejja hija bbażata fuq studju kliniku ta' bivalirudin f'6,000 pazjent sottoposti għal PCI, li nofshom ġew ikkurati b'bivalirudin (REPLACE-2).
English: Angiox contains bivalirudin, a direct and specific thrombin inhibitor that binds both to the catalytic site and the anion-binding exosite of fluid-phase and clot-bound thrombin.
Maltese: Angiox fih bivalirudin, inibitur dirett u speċifiku tat-thrombin li jeħel kemm mas-sit katalittiku kif ukoll ma' l-anion-binding exosite tat-thrombin fil-fażi fluwida u clot-bound.
English: Approximately 30% of patients receiving bivalirudin experienced at least one adverse event and 3% experienced an adverse reaction.
Maltese: Madwar 30% tal-pazjenti li rċevew bivalirudin esperjenzaw mill-anqas episodju avvers wieħed u 3% esperjenzaw reazzjoni avversa.
English: • 0.5 mg/kg body weight for the intravenous injection, followed by an infusion into vein of 1.75 mg/kg body weight, per hour for the duration of the PCI.
Maltese: • 0.5 mg/kg piż korporali għall-injezzjoni ġol-vina, segwit minn infużjoni ta' 1.75 mg/kg piż korporali, kull siegħa għall-medda tal-PCI.
English: • 0.1 mg/kg body weight as an intravenous injection, followed by an infusion (drip) into vein of 0.25 mg/kg body weight per hour for up to 72 hours.
Maltese: • 0.1 mg/kg piż korporali bħala injezzjoni ġol-vina, segwita minn infużjoni (drip) fil-vina ta' 0.25 mg/kg piż korporali kull siegħa għal mhux aktar minn 72 siegħa.
English: Patients with moderate renal impairment (GFR 30-59 ml/min) undergoing PCI (whether being treated with bivalirudin for ACS or not) should receive a lower infusion rate of 1.4 mg/kg/h.
Maltese: Pazjenti b'insuffiċjenza renali moderata (GFR 30-59 ml/min) li jkunu qed jagħmlu PCI (sew jekk qed jiġu ikkurati bi bivalirudin għal ACS jew le) għandhom jirċievu rata ta' infużjoni aktar baxxa ta' 1.4 mg/kg/h.
English: Patients who are to be medically managed may continue the infusion of 0.25 mg/kg/h for up to 72 hours.
Maltese: Pazjenti li għandhom jiġu ġestiti medicament jistgħu jibqgħu jieħdu l-infużjoni ta' 0.25 mg/kg/h sa 72 siegħa.
English: - Each vial contains 250 mg bivalirudin.
Maltese: - Kull kunjett fih 250 mg bivalirudin.
English: Other medicines and Angiox tell your doctor
Maltese: Mediċini oħra u Angiox
English: A total of 17 deaths occurred after subacute stent thrombosis, 3 in the bivalirudin arm and 14 in the UFH plus GP IIb/IIIa arm.
Maltese: Total ta' 17-il mewta seħħew wara trombożi stent subakuti, 3 fil-grupp ta' bivalirudin u 14 fil-grupp ta' UFH flimkien ma' inhibitur ta' GP IIb/IIIa.
English: Patients with renal impairment should be carefully monitored for clinical signs of bleeding during PCI, as clearance of bivalirudin is reduced in these patients (see section 5.2)
Maltese: Pazjenti b'impediment tal-kliewi għandhom ikunu mmonitorjati b'attenzjoni għal sinjali kliniċi ta' fsad waqt PCI, peress li l-clearance ta' bivalirudin hija mnaqqsa f'dawn il-pazjenti (ara sezzjoni 5.2).
English: Reperfusion injury (no or slow reflow), Contusion a. ADRs identified in post-marketing experience b. Compartment syndrome has been reported as a complication of forearm haematoma following administration of bivalirudin via the radial access route in post-marketing experience c. Further detail regarding stent thrombosis is provided in section 4.8: The HORIZONS Trial (Patients with STEMI undergoing primary PCI).
Maltese: Iżjed dettalji dwar trombożi wara stent huma provduti f'sezzjoni 4.8: Il-Prova HORIZONS (Pazjenti b' STEMI li jkunu sottomessi għal PCI primarju).
English: • Approved dose in patients undergoing percutaneous coronary intervention (PCI): The licensed and approved dosing regimen of Angiox is an intravenous (IV) bolus injection of 0.75 mg/kg body weight followed immediately by an intravenous infusion at 1.75 mg/kg/hour for at least the duration of the PCI.
Maltese: Id-dożaġġ illiċenzjat u approvat ta' angiox huwa injezzjoni bolus minn ġol-vina (IV) ta' 0.75mg/kg piż tal ġisem segwit immedjatament b' infużjoni minn ġol-vina ta' 1.75 mg/kg/siegħa għal mill-inqas it-tul tal-PCI.
English: For instructions for monitoring acute stent thrombosis, see section 4.4. d. Section 4.4 describes precautions for INR monitoring when bivalirudin is co-administered with warfarin.
Maltese: Għal struzzjonijiet dwar il-monitoraġġ ta' trombożi akuta wara stent, ara sezzjoni 4.4. d.Sezzjoni 4.4 tiddiskrivi l-prekawzjonijiet għal monitoraġġ ta' INR meta jingħata bivalirudin flimkien ma' warfarina.
English: Posology
Maltese: Komponenti
English: Reconstituted solution: Store in a refrigerator (2-8C).
Maltese: Aħżen fi friġġ (2-8C).
English: The pharmacokinetics of bivalirudin have not been studied in patients with hepatic impairment but are not expected to be altered because bivalirudin is not metabolized by liver enzymes such as cytochrome P-450 isozymes.
Maltese: Il-farmakokinetiċi ta' bivalirudin ma ġewx studjati f'pazjenti b'indeboliment tal-fwied iżda mhumiex mistennija li jinbidlu minħabba li bivalirudin ma jiġix metabolizzat minn enzimi tal-fwied bħallisoenzimi taċ-ċitokromu P-450.
English: Powder for concentrate for solution for injection or infusion 10 vials
Maltese: Trab għal konċentrat għal soluzzjoni għal injezzjoni jew infużjoni 10 kunjetti
English: Medicinal products with dose concentration incompatibilities to bivalirudin.
Maltese: Prodotti mediċinali b'inkompatibilitajiet fir-rigward tal-konċentrazzjoni tad-doża għal bivalirudin.
English: After reconstitution 1 ml contains 50 mg bivalirudin.
Maltese: Wara rikostituzzjoni 1 ml ikun fih 50 mg bivalirudin.
English: A total of 356 (7.7%) of patients randomised to Arm C also received a GP IIb/IIIa inhibitor.
Maltese: Total ta' 356 (7.7%) tal-pazjenti randomizzati għal Fergħa Ċ irċevew ukoll inibitur GPIIb/IIIa.
English: Haematuria
Maltese: Emorraġija
English: Administration errors may lead to fatal thrombosis.
Maltese: Żbalji fl-amministrazzjoni jistgħu jwasslu għal trombożi fatali.
English: 30-day Composite ischaemia
Maltese: 30-jum Iskemja komposta mhux ippjanata sena
English: See section 6.2 for the summary of compatible and incompatible concentrations of these compounds.
Maltese: Ara sezzjoni 6.2 għas-sommarju tal-konċentrazzjonijiet kompatibbli u mhux kompatibbli ta' dawn is-sustanzi.
English: The majority of these patients received concomitant acetylsalicylic acid and clopidogrel, and 6 out of the 10 patients also received a GP IIb/IIIa inhibitor.
Maltese: Il-maġġoranza ta' dawn il-pazjenti rċevew acetylsalicylic acid u clopidogrel fl-istess ħin, u 6 minn 10 pazjenti irċievew ukoll inibitur GP IIb/IIIa.
English: ACUITY major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site haemorrhage requiring radiological or surgical intervention, ≥5 cm diameter haematoma at puncture site, reduction in haemoglobin concentration of ≥4 g/dl without an overt source of bleeding, reduction in haemoglobin concentration of ≥3 g/dl with an overt source of bleeding, re-operation for bleeding, use of any blood product transfusion.
Maltese: Fsada maġġuri definita bħala waħda minn dawn li ġejjin: emorraġija intrakranjali, retroperitonjali, intraokulari, fis-sit ta' l-aċċess li teħtieġ intervent radjuloġiku jew kirurġiku, ematoma b'dijametru ta' ≥5 ċm fis-sit tat-titqiba, tnaqqis fil-konċentrazzjoni ta' l-emoglobina ta' ≥ 4 g/dl mingħajr sors ovvju ta' fsada, tnaqqis fil-konċentrazzjoni ta' l-emoglobina ta' ≥3 g/dl b'sors ovvju ta' fsada, operazzjoni mill-ġdid għall-fsada jew l-użu ta' kwalunkwe trasfużjoni bi prodott tad-demm.
English: Use with other anticoagulant therapy
Maltese: Użu ma' terapija oħra ta' kontra l-koagulazzjoni
English: Approximately 77% of patients had recurrent ischaemia, approximately 70% had dynamic ECG changes or elevated cardiac biomarkers, approximately 28% had diabetes and approximately 99% of patients underwent angiography within 72 hours.
Maltese: Madwar 77% tal-pazjenti kellhom iskemja rikorrenti, madwar 70% kellhom tibdil dinamiku fl-ECG jew bijomarkaturi kardijaċi għoljin, bejn wieħed u ieħor 28 % kellhom id-dijabete u bejn wieħed u ieħor 99% tal-pazjenti kellhom jgħaddu minn anġjografika fi żmien 72 siegħa.
English: Diluted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 25C.
Maltese: Stabilità kimika u fiżika waqt l-użu ġiet murija għal 24 siegħa f'temperatura ta' oC.
English: The incidence of both ACUITY-scale and TIMI-scale bleeding events to day 30 for the per protocol population are presented in Table 7.
Maltese: L-inċidenza ta' fsad kemm fl-iskala ACUITY u TIMI sa jum 30 għal popolazzjoni tal-protokol huma preżentati f'tabella 7.
English: In Arms B and C of the ACUITY trial, the recommended dose of bivalirudin was an initial postrandomisation intravenous bolus of 0.1 mg/kg followed by a continuous intravenous infusion of 0.25 mg/kg/h during angiography or as clinically warranted.
Maltese: Fil-fergħat B u Ċ tal-prova ta' ACUITY, id-doża rakkomandata ta' bivalirudin kienet bolus ġol-vina inizjali ta' wara r-randomizzazzjoni ta' 0.1 mg/kg segwita minn infużjoni ġol-vina kontinwa ta' 0.25 mg/kg/h matul anġjografija jew kif klinikament garantit.
English: ACUITY scale major bleeding
Maltese: Fsad maġġuri skala
English: Bivalirudin inhibits each of these thrombin effects.
Maltese: Bivalirudin jimpedixxi dawn l-effetti kollha tat-thrombin.
English: Bleeding definitions and outcomes from the REPLACE-2 trial are shown in Table 6.
Maltese: Definizzjonijiet ta' fsad u r-riżultati mill-provi REPLACE-2 huma murija f'Tabella 6.
English: • if you are having radiation treatment in the vessels that supply blood to the heart (treatment called beta or gamma brachytherapy).
Maltese: (trattament imsejjaħ brakiterapija beta jew gamma).
English: Excipient
Maltese: Eċċipjenti
English: All patients received acetylsalicylic acid and clopidogrel with twice as many patients (approximately 64%) receiving a 600mg loading dose of clopidogrel than a 300mg loading dose of clopidogrel.
Maltese: Il-pazjenti kollha rcievew acetylsalicylic acid u clopidogrel, bid-doppju tal-pazjenti ( madwar 64%) li rċievew 600mg ta' clopidogrel bħala doża għolja tal-bidu minnflok 300mg ta' clopidogrel bħala doża għolja tal-bidu.
English: Reconstituted material should then be further diluted in a total volume of 50 ml to give a solution of 5 mg/ml bivalirudin.
Maltese: Imbagħad, il-materjal rikostitwit għandu jiġi dilwit aktar f'volum totali ta' 50 ml sabiex jirriżulta f'soluzzjoni ta' 5 mg/ml bivalirudin.
English: About 20% of bivalirudin is excreted unchanged in the urine.
Maltese: Madwar 20% ta' bivalirudin jitneħħa mhux mibdul fl-awrina.
English: **p0.001
Maltese: [TMC-BIV-07-01].
English: The Medicines Company UK Ltd Tel. Nr.: +370 880031794 arba +370 852140678
Maltese: Nr.: +370 880031794 arba +370 852140678
English: Based on the short half-life of bivalirudin (25 minutes), failure to initiate an infusion following the Angiox bolus will result in a plasma concentration that is below the required level within minutes
Maltese: Minħabba l-half life qasir ta' bivalirudin (25 minuta), jekk ma jinbediex infużjoni wara bolus b' Angiox, fi ftit minuti il- konċentrazzjoni fil-plażma tkun iżjed baxxa milli hi meħtieġa.
English: Rarely this may require surgery to repair the blood vessel in the groin (fistula, pseudoaneurysm) (may affect up to 1 in 1,000 people).
Maltese: Rarament jista' ikun hemm bżonn kirurġija sabiex issewwi il-vini jew arterji tad-demm fil-parti rqiqa ta' bejn il-koxxox u ż-żaqq (fistula, psewdoanuriżma) (jistgħu jaffetwaw sa 1 minn 1,000 persuna).
English: Lyophilised (freeze-dried) powder: Do not store above 25C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25C.
English: • Slow heartbeat
Maltese: • fsad minuri
English: The ACT vs concentration data suggest a trend for a lower concentration response curve for adults as compared to older children (6 years to < 16 years) and younger children (2 years to <6 years), and for older children compared to infants (31 days to <24 months) and neonates (birth to 30 days).
Maltese: L-ACT vs dejta dwar ilkonċentazzjoni jissuġġerixxi andament lejn kurva ta' rispons-konċentrazzjoni iżjed baxxa għall-adulti meta mqabbla ma' tfal akbar (minn 6 snin sa < 16-il sena) u tfal iżgħar (minn sentejn sa <6 snin), u għal tfal akbar meta mqabbla ma' trabi (31 ġurnata sa <24 xahar) u trabi tat-twelid (mit-twelid sa 30 ġurnata).
English: Intent-to-treat
Maltese: Bijotrasformazzjoni
English: From the knowledge of their mechanism of action, combined use of anti-coagulant medicinal products (heparin, warfarin, thrombolytics or antiplatelet agents) can be expected to increase the risk of bleeding.
Maltese: Minn dak li huwa magħruf dwar il-mekkaniżmu ta' azzjoni tagħhom, l-użu kombinat ta' prodotti mediċinali antikoagulanti (eparina, warfarin, trombolitiċi jew sustanzi kontra l-plejtlits) jista' jkun mistenni li jżid ir-riskju ta' fsada.
English: • INR test (warfarin blood test result) increased (see Section 2, Other medicines and Angiox)
Maltese: Effetti sekondarji rari (jistgħu jaffetwaw sa 1 minn 1,000 persuna) żieda fit-test INR (riżultat tat-test tad-demm tal-warfarin) (ara Sezzjoni 2, Mediċini oħra u Angiox)
English: Major bleeding rates for the intent-to-treat trial population are shown in Table 6.
Maltese: Ir-rati ta' fsada maġġura għall-popolazzjoni tal-intenzjoni ta' kura huma indikati fit-Tabella 6.
English: Breastfeeding
Maltese: Bivalirudin
English: Pharmacokinetic parameters for bivalirudin in patients with normal and impaired
Maltese: Parametri farmakokinetiċi għal bivalirudin f'pazjenti b'funzjoni tal-kliewi
English: Both major and minor bleeds were significantly less frequent with bivalirudin alone than the heparin plus GP IIb/IIIa inhibitor and bivalirudin plus GP IIb/IIIa inhibitor groups.
Maltese: Kemm fsad minuri kif ukoll fsad maġġuri kienu ferm inqas frekwenti b'bivalirudin waħdu milli l-eparina flimkien ma' Inibitur GP IIb/IIIa u bivalirudin flimkien ma' gruppi ta' inibituri GP IIb/IIIa.
English: • 0.75 mg/kg body weight as an intravenous injection, followed immediately by an infusion (drip) into vein of 1.75 mg/kg body weight, per hour for at least the duration of the PCI.
Maltese: • 0.75 mg/kg piż korporali bħala injezzjoni ġol-vini, segwita minnufih minn infużjoni (dripp) ġol-vina ta' 1.75 mg/kg piż korporali, kull siegħa għal mill-inqas il-medda tal-PCI.
English: • severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients 4.4 Special warnings and precautions for use
Maltese: • indeboliment sever tal-kliewi (GFR <30 ml/min) u f'pazjenti dipendenti fuq id-dijalisi
English: Angina pectoris,
Maltese: Pazjenti pedjatriċi
English: The pharmacokinetic properties of bivalirudin have been evaluated and found to be linear in patients undergoing Percutaneous Coronary Intervention and in patients with ACS.
Maltese: Il-kwalitajiet farmakokinetiċi ta' bivalirudin ġew evalwati u nstabu li huma lineari f'pazjenti sottoposti għal Intervent Koronarju Perkutanju u f'pazjenti b'ACS Assorbiment
English: Major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than 3 g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified.
Maltese: Fsada maġġuri ġiet definita bħala s-seħħ ta' xi waħda minn dawn li ġejjin: emorraġija intrakranjali, emorraġija retroperitonali, telf ta' demm li jwassal għal trasfużjoni ta' mill-anqas żewġ unitajiet ta' demm sħiħ jew ċelloli ħomor tad-demm ippakkjati, jew fsada li tirriżulta fi tnaqqis fl-emoglobina ta' aktar minn 3 g/dl, jew tnaqqis fl-emoglobina ta' aktar minn 4 g/dl (jew 12% ta' l-ematokrit) mingħajr ma jkun identifikat l-ebda sit ta' fsada.
English: REPLACE-2 major bleeding was defined as the occurrence of any of the following: intracranial haemorrhage, retroperitoneal haemorrhage, blood loss leading to a transfusion of at least two units of whole blood or packed red blood cells, or bleeding resulting in a haemoglobin drop of more than 3 g/dl, or a fall in haemoglobin greater than 4 g/dl (or 12% of haematocrit) with no bleeding site identified.
Maltese: Fsad maġġuri f' REPLACE-2 bħala l-okkorrenza ta' qwalunkwe minn li ġejjin: emorraġija ġewwa lkranju, wara l-peritonew, telf ta' demm li jwassal għal trasfużżjoni ta' mill-inqas żewġ unitajiet ta' demm sħieħ jew ċelloli tad-demm ħomor ippakkjati, jew fsad li jirriżulta f'tnaqqis ta' emoglobina ta' iżjed minn 3 g/dl, jew tnaqqis fil-konċentrazzjoni ta' l-emoglobina ta' iżjed minn 4 g/dl (jew 12% ta' ematokrit) mingħajr sit ta' fsada identifikat.
English: For patients who proceed to coronary artery bypass graft (CABG) surgery off pump, the intravenous infusion of bivalirudin should be continued until the time of surgery.
Maltese: Għal pazjenti li jipproċedu għal kirurġija ta' bypass graft ta' l-arterja koronarja (CABG) tat-tip off pump, l-infużjoni fil-vini ta' bivalirudin għandha titkompla sal-ħin tal-kirurġija.
English: The advantage of bivalirudin over UFH/enoxaparin plus GP IIb/IIIa inhibitor in terms of bleeding events was only observed in the bivalirudin monotherapy arm.
Maltese: Ilvantaġġ ta' bivalirudin fuq UFH/enoxaparin flimkien ma' inhibitur ta' GP IIb/IIIa f'termini ta'ġrajjiet ta' fsad kien osservat biss fil-parti tal-istudju b'monoterapija b'bivalirudin.
English: Acute stent thrombosis
Maltese: TA' KIF JINGĦATA
English: Injury, poisoning and procedural complications
Maltese: Korriment, avvelenament u komplikazzjonijiet proċedurali