FrancophonIA/ELRC3.0 huggingface dataset:
English: The HORIZONS trial was a prospective, dual arm, single blind, randomised, multi-centre trial to establish the safety and efficacy of bivalirudin in patients with STEMI undergoing a primary PCI strategy with stent implantation with either a slow release paclitaxel-eluding stent (TAXUS™) or an otherwise identical uncoated bare metal stent (Express2™).
Maltese: Il-prova HORIZONS kienet prova prospettiva, dual arm, single blind, randomised u multi-centre biex tistabbilixxi s-sigurta' u l-effikaċja ta' bivalirudin f'pazjenti b' STEMI sottoposti minn strateġija ta' PCI primarju b'impjantazzjoni stent jew b'stent li jirħi paclitaxel b'rilaxx bil-mod (TAXUS™) jew b' stent li hu identiku ħlief għal fatt li hu tal-metal u mhux miksi (Express2™).
English: Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.
Maltese: Angiox huwa indikat bħala antikoagulant f'pazjenti adulti sottoposti għal intervent koronarju perkutanju (PCI), inkluż dawk il-pazjenti b'infart mijokardjali b'elevazzjoni segmentali ST (STEMI) li għaddejjin minn PCI primarju.
English: The Medicines Company UK Ltd Tel : +44 (0)800 587 4149 or +44 (0)203 684 6344
Maltese: United Kingdom The Medicines Company UK Ltd Tel: +44 (0)800 587 4149 or +44 (0)203 684 6344
English: Rare (≥1/10,000 to
Maltese: Rari sa<1/1,000)
English: Clearance is reduced by approximately 20% in patients with moderate or severe renal impairment, and 80% in dialysis-dependent patients (Table 8).
Maltese: It-tneħħija tonqos b'madwar 20% f'pazjenti b'indeboliment moderat jew sever tal-kliewi, u bi 80% fil-pazjenti dipendenti fuq id-dijalisi (Tabella 8).
English: Angiox is available in cartons containing 10 vials.
Maltese: Angiox jiġi f'kartuniet li fihom 10 kunjetti.
English: In clinical study TMC-BIV-07-01, the pharmacodynamic response as measured by ACT was consistent with adult studies.
Maltese: Fi studju kliniku TMC-BIV-07-01, ir-rispons farmakodinamiku kif imkejjel minn ACT kien konsistenti ma' studji fl-adulti.
English: Intraocular haemorrhage
Maltese: Emorraġija Intraokulari
English: heparin  GP IIb/IIIa inhibitor (N=2,882)
Maltese: heparin  inhibitur ta' GP IIb/IIIa (N=2,882)
English: The mean steadystate concentration of bivalirudin following a constant intravenous infusion of 2.5 mg/kg/h is 12.4 µg/ml.
Maltese: Il-konċentrazzjoni fissa medja ta' bivalirudin wara infużjoni kostanti fil-vini ta' 2.5 mg/kg/siegħa hija ta' 12.4 µg/ml.
English: In a clinical trial of 110 paediatric patients (neonates to <16 years of age) undergoing percutaneous intravascular procedures, the safety, pharmacokinetic and pharmacodynamic profile of bivalirudin was evaluated [TMC-BIV-07-01].
Maltese: F'prova klinika ta' 110 pazjent pedjatriku (trabi tat-twelid sa <16-il sena) li sarulhom proċeduri perkutanji intravaskulari, ġew evalwati s-sigurtà, il-profil farmakokinetiku u farmakodinamiku ta' bivalirudin
English: • In the ImproveR registry bolus dosing (without subsequent infusion) was observed in EU clinical practice.
Maltese: • Fir- reġistrar ta' ImproveR dożaġġbolus (mingħajr infużjoni wara) kien osservat fil- prattika klinika fl-EU.
English: Educational material includes a slide deck presentation, dosing cards as described in the risk minimization measures in the RMP, and a copy of the SmPC.
Maltese: Materjal edukattiv jinkludi preżentazzjoni bi slides, kartuniet tad-dożaġġ kif deskrit fil-miżuri għall-minimazzjoni tar-riskji fl-RMP, u kopja tal SmPC.
English: Patients receiving acetylsalicylic acid & clopidogrel as per protocol* Arm A UFH/enox +GP IIb/IIIa inhibitor (N=2,842)
Maltese: Pazjenti li rċievew acetylsalicylic acid u klopidogrel skond il-protokoll Fergħa A UFH/enox +inibitur GPIIb/IIIa (N=4603)
English: The systemic clearance of bivalirudin decreases with glomerular filtration rate (GFR).
Maltese: It-tneħħija sistemika ta' bivalirudin tonqos bir-rata tal-filtrazzjoni glomerulari (GFR).
English: Brachytherapy
Maltese: Brakiterapija
English: Similar reductions in bleeding were observed in patients who were switched to bivalirudin from heparin-based therapies (N = 2,078).
Maltese: Tnaqqis simili filfsad ġie osservat f'pazjenti li nqelbu għal bivalirudin minn terapiji bbażati fuq l-eparina (N = 2,078).
English: The 30-day results based on quadruple and triple endpoints from a randomized, double-blind trial of over 6,000 patients undergoing PCI (REPLACE-2) are shown in Table 5.
Maltese: Ir-riżultati wara jum-30 ibbażati fuq il-punti ta' l-aħħar tripli u quadruple minn prova randomised u double blind ta' iżjed minn 6,000 pazjent sottoposti għal PCI (REPLACE-2) huma murija f'Tabella 5.
English: Withdraw 5 ml from the vial, and further dilute in a total volume of 50 ml of glucose 5% solution for injection, or sodium chloride 9 mg/ml (0.9%) solution for injection to give a final bivalirudin concentration of 5 mg/ml.
Maltese: Iġbed 5 ml mill-kunjett, u kompli ddilwa f'volum totali ta' 5% 50 ml ta' soluzzjoni għal injezzjoni ta' glucose, jew soluzzjoni għal injezzjoni ta' sodium chloride 9 mg/ml (0.9%) biex tagħti konċentrazzjoni finali ta' bivalirudin ta' 5 mg/ml.
English: Compatible concentrations Incompatible concentrations
Maltese: Konċentrazzjonijiet inkompatibbli
English: Angiox should be administered with acetylsalicylic acid and clopidogrel.
Maltese: Angiox għandu jingħata ma' acetylsalicylic acid u clopidogrel.
English: If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered and the ACT re-checked 5 minutes after the administration of the second bolus dose.
Maltese: Jekk l-ACT ta' 5 minuti tkun inqas minn 225 sekonda, it-tieni doża bolus ta' 0.3mg/kg għandha tingħata u l-ACT terġa' tiġi ċċekkjata 5 minuti wara l-amministrazzjoni tat-tieni doża bolus.
English: Contents of the pack and other information
Maltese: KONTENUT TAL-PAKKETT U INFORMAZZJONI OĦRA
English: The ACUITY trial was a prospective, randomised open-label, trial of bivalirudin with or without GP IIb/IIIa inhibitor (Arms B and C respectively) versus unfractionated heparin or enoxaparin with GP IIb/IIIa inhibitor (Arm A) in 13,819 high risk ACS patients.
Maltese: Il-prova ta' ACUITY kienet prova prospettiva, randomised open-label ta' bivalirudin bi jew mingħajr inibitur GP IIb/IIIa (Fergħat B u Ċ rispettivament) meta mqabbla ma' eparina jew enoxaparina mhux frazzjonata b'inibitur GP IIb/IIIa (Fergħa A) fi 13,819-il pazjent ta' ACS b'riskju għoli.
English: The Medicines Company UK Ltd Tel : +421 (0 )268622610 alebo +421 (0) 268622610
Maltese: Slovenská republika The Medicines Company UK Ltd Tel: +421 (0 )268622610 alebo +421 (0) 268622610
English: Thrombocytopenia was reported in 10 bivalirudin-treated patients participating in the ACUITY study (0.1%).
Maltese: Tromboċitopenja ġiet irrapportata f'10 pazjenti ttrattati b'bivalirudin fl-istudju ta' ACUITY (0.1%).
English: The approved adult weight-based intravenous bolus dose of 0.75 mg/kg followed by an infusion of 1.75 mg/kg/hour was studied and pharmacokinetic/pharmacodynamic analysis found a response similar to that of adults, although weight-normalized clearance (ml/min/kg) of bivalirudin was higher in neonates than in older children and decreased with increasing age.
Maltese: Id-doża bolus fil-vina approvata għall-adulti bbażata fuq il- piż ta' 0.75 mg/kg segwita minn infużjoni ta' 1.75 mg/kg/siegħa, kienet studjata, u analiżi farmakokinetika/farmakodinamika sabet rispons simili għal dak tal-adulti, għalkemm it-tneħħija normalizzata għall-piż (ml/min/kg) ta' bivalirudin kienet ogħla fit-trabi tat-twelid milli minn fi tfal akbar, u naqset maż-żieda fl-età.
English: Angiox contains a substance called bivalirudin which is an antithrombotic medicine.
Maltese: Angiox fih sustanza msejħa bivalirudin li hija mediċina anti-trombotika.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu skeltrali u tattessut konnettiv
English: In vitro studies have indicated that bivalirudin inhibits both soluble (free) and clot-bound thrombin.
Maltese: Studji in vitro indikaw li bivalirudin jimpedixxi kemm thrombin solubbli (liberu) kif ukoll clot-bound.
English: • Angiox is contraindicated in patients with severe renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min) and in dialysis-dependent patients.
Maltese: • Angiox huwa kontraindikat f'pazjenti b' insuffiċenza severa tal-kliewi (rata ta' filtrazzjoni glomerulari(GFR) < 30 ml/min) u f'pazjenti dependenti fuq id-dijaliżi.
English: Intra-procedural thrombus formation has been observed during gamma brachytherapy procedures with Angiox.
Maltese: Kienet osservata formazzjoni ta' thrombus intra-proċedurali waqt proċeduri ta' gamma brakiterapija b'Angiox.
English: Currently available data are described in sections 5.1 and 5.2.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 5.1 u 5
English: Your warfarin blood test result (INR test) may be affected by Angiox.
Maltese: It-test tal-warfarina fid-demm tiegħek (test INR) jista' jiġi affetwat minn Angiox.
English: Bival + GP IIb/IIIa inhibitor
Maltese: Bival + inhibitur ta' GP IIb/IIIa
English: Allergic type hypersensitivity reactions were reported uncommonly (≥1/1,000 to ≤1/100) in clinical trials.
Maltese: Reazzjonijiet ta' sensittività eċċessiva li jixbhu allerġija ġew irrappurtati b'mod mhux komuni (≥1/1,000 sa ≤1/100) fi provi kliniċi.
English: HOW TO STORE ANGIOX
Maltese: Tużax Angiox
English: The most frequent event was a haematoma <5 cm at puncture site.
Maltese: L-iżjed effett frekwenti kien ematoma <5 cm fil-post tat-titqib.
English: If the 5-minute ACT is less than 225 seconds, a second bolus dose of 0.3 mg/kg should be administered.
Maltese: Jekk lACT ta' 5 minuti jkun anqas minn 225 sekonda, għandha tingħata t-tieni doża bolus ta' 0.3 mg/kg.
English: Major bleeding rates are shown in Table 6 for the IIT population and Table 7 for the per protocol population (patients receiving clopidogrel and acetylsalicylic acid).
Maltese: Ir-rati ta' fsada maġġuri huma indikati fit-Tabella 6 għal popolazzjoni ITT u Tabella 7 għal popolazzjoni skont il protocol (pazjenti li jirċievu clopidogel u acetylsalicylic acid).
English: • If you are taking blood thinners or medicines to prevent blood clots (anticoagulants or antithrombotics e.g. warfarin, dabigatran, apixaban, rivaroxaban, acetylsalicylic acid,
Maltese: (anti-koagulanti jew antitrombotiċi eż. warfarin, dabigatran, apixaban, rivaroxaban,
English: TIMI scale major bleeding *clopidogrel pre-angiography or pre-PCI
Maltese: Fsad maġġuri skala TIMI *klopidogrel pre-anġjografija jew pre-PCI
English: Bleeding Definitions
Maltese: Definizzjonijet ta' Fsad
English: Approximately 23.3% of patients receiving bivalirudin experienced at least one adverse event and 2.1% experienced an adverse reaction.
Maltese: Bejn wieħed u ieħor 23.3% tal-pazjenti li rċievew bivalirudin esperjenzaw għallinqas episodju avvers wieħed u 2.1% esperjenzaw reazzjoni avversa.
English: • if you have been treated before with medicines similar to Angiox (e.g. lepirudin).
Maltese: • jekk ħadt xi kura qabel b'mediċini simili għal Angiox (pereżempju lepirudin)
English: Data from 366 patients indicates that the ACT is unaffected by concomitant treatment with a GP IIb/IIIa inhibitor.
Maltese: Id-dejta minn 366 pazjent tindika li l-ACT mhux affettwat minn kura simultanju b'inibitur tal-GP IIb/IIIa.
English: heparin  GP IIb/IIIa inhibitor (N=3,008)
Maltese: eparina  inhibitur ta' GP IIb/IIIa (N=3,008)
English: 50 ml] of glucose solution or sodium chloride solution) 1 ml contains 5 mg bivalirudin.
Maltese: - Wara dilwizzjoni (tħallat 5 ml ta' soluzzjoni rikonstitwita ġo borża ta' infużjoni [volum totali ta' 50 ml] ta' soluzzjoni ta' glucose jew sodium chloride) 1 ml fih 5 mg bivalirudin.
English: Adverse drug reactions for bivalirudin are listed by system organ class in Table 1.The incidence of stent thrombosis within the first 24 hours was 1.5% in patients receiving bivalirudin versus 0.3% in patients receiving UFH plus GP IIb/IIIa inhibitor (p=0.0002).
Maltese: L-inċidenza ta' trombożi stent fi żmien 24 siegħa kienet ta' 1.5% fil-pazjenti li jieħdu bivalirudin meta mqabbla ma' 0.3% f'pazjenti li jieħdu UFH flimkien ma' inhibitur ta' GP IIb/IIIa (p=0.0002).
English: Heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia-thrombosis syndrome (HIT/HITTS)
Maltese: Tromboċitopenija indotta mill-eparina (HIT) u s-sindrome tat-tromboċitopenija-trombożi indotta milleparina (HIT/HITTS).
English: ACUITY trial; bleeding events up to day 30 for the population of patients who received acetylsalicylic acid and clopidogrel as per protocol*
Maltese: Tabella 7 Prova ta' ACUITY; episodji ta' fsada sa jum 30 għall-popolazzjoni ta' pazjenti li rċevew acetylsalicylic acid u clopidogrel skont il-protokoll*
English: Arm C bival alone (N=4,612)
Maltese: Fergħa C bival waħdu (N=4612)
English: Adverse reactions for bivalirudin from HORIZONS, ACUITY, REPLACE-2 trials and post-marketing experience are listed by system organ class in Table 1.
Maltese: Ir-reazzjonijiet avversi għal bivalirudin meħudin mill-provi HORIZONS, ACUITY, REPLACE-2 u mill-esperjenza ta' wara t-tqegħid fis-suq huma mniżżlin skont is-sistema tal-klassifika tal-organi f' Tabella 1.
English: Bival + GP IIb/IIIa inhibitor (N=2,924)
Maltese: Bival + inhibitur ta' GP IIb/IIIa (N=2,924) %
English: Pharmacokinetics have been evaluated in elderly patients as part of a renal pharmacokinetic study.
Maltese: Il-farmakokinetiċi ġew evalwati f'pazjenti anzjani bħala parti minn studju farmakokinetiku renali.
English: Bleeding definitions and outcomes from the HORIZONS trial are shown in Table 6.
Maltese: Id-definizzjonijiet ta' fsad u r-riżultati mill-prova HORIZONS huma murija f'Tabella 6.
English: + GP IIb/IIIa inhibitor (%)
Maltese: + inhibitur ta' GP IIb/IIIa (%)
English: In ACUITY, bleeding data were collected separately from adverse reactions.
Maltese: F'ACUITY, id-dejta dwar il-fsad inġabret separatament minn reazzjonijiet avversi.
English: All 5 events were associated with additional cardiac procedures employing heparin anticoagulation (n=3) or with infections (n=2).
Maltese: Il-ħames avvenimenti kollha kienu assoċjati ma' proċeduri kardijaċi addizzjonali li jużaw antikoagulazzjoni b'eparina (n=3) jew b'infezzjonijiet (n=2).
English: However, bivalirudin was not mutagenic or clastogenic in standard assays for such effects.
Maltese: Madankollu, bivalirudin ma kienx mutaġeniku jew klastoġeniku f'assays standard għal effetti simili.
English: The bolus dose remains 0.75 mg/kg (or 0.5 mg/kg in patients who proceed to PCI after receiving bivalirudin pre-cath lab (UA/NSTEMI)).
Maltese: Id-doża bolus tibqa 0.75 mg/kg (jew 0.5 mg/kg f'pazjenti li jmorru għal PCI wara li jirċievu bivalirudin pre-cath lab (UA/NSTEMI)).
English: Patients undergoing PCI, including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI
Maltese: Pazjenti sottoposti għal PCI, inkluż pazjenti b'infart mijokardijaku ta' elevazzjoni tas-segment ST (STEMI
English: In vitro studies have also shown that bivalirudin prolongs the activated partial thromboplastin time (aPTT) thrombin time (TT) and pro-thrombin time (PT) of normal human plasma in a concentrationdependent manner and that bivalirudin does not induce a platelet aggregation response against sera from patients with a history of Heparin-Induced Thrombocytopenia/Thrombosis Syndrome (HIT/HITTS).
Maltese: Studji in vitro wrew ukoll li bivalirudin itawwal it-thromboplastin time parzjali attivat (aPTT), itthrombin time (TT) u l-pro-thrombin time (PT) ta' plażma umana normali b'mod dipendenti fuq il konċentrazzjoni u li bivalirudin ma jinduċix rispons ta' aggregazzjoni tal-plejtlits kontra sera minn pazjenti bi preċedent tas-Sindrome tat-Tromboċitopenija/Trombożi
English: In STEMI patients undergoing primary PCI, standard pre-hospital adjunctive therapy should include clopidogrel and may include the early administration of UFH (See section 5.1).
Maltese: F'pazjenti STEMI sottoposti għal PCI primarju, it-terapija aġġuntiva li tingħata s-soltu qabel ma' jidħlu l-isptar għandha tinkludi clopidogrel u tista' tinkludi t-teħid bikri ta' UFH (Ara sezzjoni 5.1).
English: A total of 55.1% of patients receiving bivalirudin experienced at least one adverse event and 8.7% experienced an adverse drug reaction.
Maltese: Total ta' 55.1% tal-pazjenti li jieħdu bivalirudin kellhom mill-inqas effett avvers wieħed u 8.7% kellhom xi reazzjoni avversa għall-mediċina.
English: Myocardial infarction,
Maltese: Infart mill-ġdid
English: Hälsa Pharma GmbH, Nikolaus Dürkopp-Str. 4A, 33602 Bielefeld, GERMANY
Maltese: 4A, 33602 Bielefeld, Il-Ġermanja
English: ACUITY trial; 30-day and 1-year risk differences for the composite ischaemic endpoint and its components for patients that received acetylsalicylic acid and clopidogrel as per protocol*
Maltese: Prova ta' ACUITY; differenzi fir-riskju wara 30 jum u sena għal punt ta' tmiem iskemiku kompost u l-komponenti tiegħu għall-pazjenti li rċievew acetyl salicylic acid u klopidogrel skond il-protokoll*
English: Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8C.
Maltese: Stabilità kimika u fiżika waqt l-użu ġiet murija għal 24 siegħa f'temperatura ta' 2-8
English: Acute cardiac events
Maltese: Ġrajjiet kardijaċi akuti
English: The corresponding clearance is about 3.4  0.5 ml/min/kg.
Maltese: It-tneħħija korrispondenti hija ta' madwar 3.4  0.5 ml/min/kg.
English: Hypersensitivity, including anaphylactic reaction and shock, including reports with fatal outcome
Maltese: Ipersensittivita` inklużi reazzjoni anafilattika u xokk, inklużi rapporti b'eżitu fatali
English: Unfractionated heparin + GP IIb/IIIa inhibitor (%)
Maltese: Eparina mhux frazzjonata + inhibitur ta' GP IIb/IIIa (%)
English: Adverse event reactions for bivalirudin are listed by system organ class in Table 1.
Maltese: L-episodji avversi għal bivalirudin huma elenkati skond is-sistema talklassifika ta' l-organi f'Tabella 1.
English: Bleeding is more likely to occur when Angiox is used in combination with other anticoagulant or antithrombotic medicines (see section 2 ‘Taking other medicines').
Maltese: Hemm iżjed probabbiltà li sseħħ fsada meta Angiox jintuża f'kombinazzjoni ma' mediċini antikoagulanti jew antitrombotiċi oħrajn (ara sezzjoni 2 ‘Meta tieħu mediċini oħra)
English: The following data are based on a clinical study of bivalirudin in patients with STEMI undergoing primary PCI; 1,800 patients were randomised to bivalirudin alone, 1,802 were randomised to heparin plus GP IIb/IIIa inhibitor.
Maltese: Id-dejta li ġejja huma bbażati fuq studju kliniku ta' bivalirudin f'pazjenti b'STEMI li huma sottoposti għal PCI primarju, 1,800 pazjent kienu randomised fuq bivalirudin biss, 1,802 kienu randomised fuq eparina flimkien ma' inhibitur ta' GP IIb/IIIa.
English: Anaphylaxis, including anaphylactic shock with fatal outcome has been reported very rarely (≤1/10,000) in post-marketing experience (see section 4.8).
Maltese: Anafilassi, inkluż xokk anafilattiku b'eżitu fatali ġiet irrapportata rari ħafna (≤1/10,000) flesperjenza ta' wara t-tqegħid tal-prodott fis-suq (ara sezzjoni 4.8).
English: Serious adverse reactions were reported more frequently in the heparin plus GP IIb/IIIa group than the bivalirudin treated group.
Maltese: Effetti avversi serji ġew irraportati iżjed frekwentament fil grupp ta' eparina flimkien ma' GP IIb/IIIa milli fil-grupp trattati b' bivalirudin.
English: • severe renal impairment (GFR<30 ml/min) and in dialysis-dependent patients.
Maltese: • indeboliment sever tal-kliewi (GFR <30 ml/min) u f'pazjenti dipendenti fuq id-dijalisi.
English: A population pharmacokinetic/pharmacodynamic analysis, and an Exposure and Adverse Event Assessment Model based on the data from this study determined that in paediatric patients, use of the adult dosing with plasma levels similar to that achieved in adults was associated with lower levels of thrombotic events with no impact on bleeding events (see section 4.2).
Maltese: Analiżi tal-farmakokinetika/farmakodinamika tal-popolazzjoni, u Mudell ta' Evalwazzjoni ta' Avvenimenti Avversi u l-Espożizzjoni bbażat fuq id-dejta minn dan l-istudju, iddetermina li f'pazjenti pedjatriċi, lużu tad-dożaġġ tal-adulti b'livelli fil-plażma simili għal dawk li jintlaħqu fl-adulti, kien assoċjat ma' livelli aktar baxxi ta' avvenimenti trombotiċi bla ebda impatt fuq avvenimenti ta' fsada (ara sezzjoni
English: Coronary artery thrombosis and coronary stent thrombosis with myocardial infarction, and catheter thrombosis have each been reported rarely.
Maltese: Kienu rappurtati rarament trombożi tal-arterja kononarja u trombożi tal-istent koronarja b'infarct mijokardjali, u trombożi tal-kateter.
English: Other less frequently observed bleeding sites with greater than 0.1% (uncommon) bleeding included “other” puncture site, retroperitoneal, gastrointestinal, ear, nose or throat.
Maltese: Siti oħra ta' fsada osservati b'mod anqas frekwenti b'aktar minn 0.1% (mhux komuni) ta' fsada kienu jinkludu sit “ieħor” ta' titqib, retroperitonali, gastro-intestinali, il-widnejn, l-imnieħer, jew il-gerżuma.
English: In patients with mild or moderate renal insufficiency, the ACS dose (0.1 mg/kg bolus/0.25 mg/kg/h infusion) should not be adjusted.
Maltese: F'pazjenti b'insuffiċjenza ħafifa jew moderata tal-kliewi, id-doża ta' ACS (0.1 mg/kg bolus/ 0.25 mg/kg/h infużjoni) ma għandhiex tiġi aġġustata.
English: Hälsa Pharma GmbH Nikolaus Dürkopp-Str. 4A 33602 Bielefeld GERMANY
Maltese: 4A 33602 Bielefeld Germanja
English: The dose of bivalirudin used in HORIZONS was the same as that used in the REPLACE-2 study (0.75 mg/kg bolus followed by a 1.75 mg/kg body weight/hour infusion).
Maltese: Id-doża ta' bivalirudin użati f' HORIZONS kienet l-istess bħal dik użata fl-istudju REPLACE-2 (0.75 mg/kg bolus segwit minn infużjoni ta' 1.75 mg/kg piż tal-ġisem/siegħa).
English: The incidence of both ACUITY-scale and TIMI-scale bleeding events up to day 30 for the intent-totreat population is presented in Table 6.
Maltese: L-inċidenza ta' episodji ta' fsada kemm ta' skala ta' ACUITY kif ukoll ta' skala ta' TIMI sa jum 30 għal popolazzjoni intenzjonata li tiġi trattata hija ppreżentata f'Tabella 6.
English: The recommended starting dose of bivalirudin for medically managed patients with acute coronary syndrome (ACS) is an intravenous bolus of 0.1 mg/kg followed by an infusion of 0.25 mg/kg/h.
Maltese: Id-doża tal-bidu rakkomandata ta' bivalirudin għal pazjenti ġestiti medikament b'sindromu konorarja akuta (ACS) hija bolus li jingħata ġol-vini ta' 0.1 mg/kg segwit b'infużjoni ta' 0.25 mg/kg/h.
English: 1 vial contains 250 mg bivalirudin.
Maltese: Kull kunjett fih 250 mg bivalirudin.
English: Instructions for preparation
Maltese: Struzzjonijiet dwar il-preparazzjoni
English: After dilution 1 ml contains 5 mg bivalirudin.
Maltese: Wara dilwizzjoni 1 ml ikun fih 5 mg bivalirudin.
English: Just prior to surgery, a 0.5 mg/kg bolus dose should be administered followed by a 1.75 mg/kg/h intravenous infusion for the duration of the surgery.
Maltese: Ftit qabel il-kirurġija, għandha tingħata doża bolus ta' 0.5 mg/kg segwita minn infużjoni fil-vini 1.75 mg/kg/h għal kemm iddum il-kirurġija.
English: Arm B bival +GP IIb/IIIa inhibitor (N=4,604)
Maltese: Fergħa B bival + inibitur GPIIb/IIIa (N=4604)
English: The results do not suggest pharmacodynamic interactions with these medicinal products.
Maltese: Ir-riżultati ma jissuġġerux interazzjonijiet farmakodinamiċi ma' dawn il-prodotti mediċinali.
English: Bivalirudin is rapidly distributed between plasma and extracellular fluid.
Maltese: Bivalirudin jiġi assorbit malajr bejn il-plażma u l-fluwidu extra-ċellulari.
English: Angiox is for injection, followed by infusion (drip), into a vein (never into a muscle).
Maltese: Angiox huwa għal injezzjoni, segwit minn infużjoni (drip), ġol-vina (qatt ġo muskolu).
English: This medicine contains less than 23 mg of sodium per vial, which means that it is essentially “sodiumfree”.
Maltese: Din il-mediċina fiha inqas minn 23 mg of sodium kull vjala, li jfisser li essenzjalment hija “mingħajr sodium”.
English: Arm A UFH/enox +GP IIb/IIIa inhibitor (N=4,603)
Maltese: UFH/enox + inhibitur ta' GP IIb/IIIa (N= 2,842) %