FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a type of epilepsy where excessive electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Maltese: Din hija tip ta' epilessija fejn ħafna attività elettrika f'naħa waħda tal-moħħ tikkawża sintomi bħal movimenti spasmodiċi għal għarrieda ta' xi parti millġisem, smigħ, xamm, jew viżta mhux ċari, tnemnim jew sens ta' biża' f'daqqa.
English: This means that Levetiracetam Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Maltese: Dan ifisser li Levetiracetam Teva huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Keppra.
English: What is Levetiracetam Teva?
Maltese: Kif jintuża Levetiracetam Teva?
English: Why has Levetiracetam Teva been approved?
Maltese: Għaliex ġie approvat Levetiracetam Teva?
English: The exact way in which levetiracetam works is still unclear but it attaches to a protein called synaptic vesicle protein 2A, which is involved in the release of chemical messengers from nerve cells.
Maltese: Il-mod preċiż kif jaħdem levetiracetam għadu mhux ċar iżda jidher li dan jaqbad ma' proteina msejħa proteina sinaptika vexxili 2A, li għandha sehem firrilaxx ta' messaġġiera kimiċi miċ-ċelloli tan-nervituri.
English: When Levetiracetam Teva is added to another epilepsy treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Maltese: Meta Levetiracetam Teva jiżdied ma' kura oħra tal-epilessija, id-doża tal-bidu f'pazjenti minn 12-il sena 'l fuq li jiżnu aktar minn 50 kg hija ta' 500 mg darbtejn kuljum.
English: Because Levetiracetam Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Maltese: Peress li Levetiracetam Teva huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testijiet biex jiġi stabbilit jekk din il-mediċina hijiex bijoekwivalenti għall-mediċina ta' referenza, Keppra.
English: When Levetiracetam Teva is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Maltese: Meta Levetiracetam Teva jintuża waħdu, id-doża tal-bidu hija ta' 250 mg darbtejn kuljum, u tiżdied ġimagħtejn wara għal 500 mg darbtejn kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Teva on 26 August 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Levetiracetam Teva valida flUnjoni Ewropea kollha fis-26 ta' Awwissu 2011.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Keppra, il-benefiċċji huma akbar mir-riskji identifikati.
English: Levetiracetam Teva is a medicine that contains the active substance levetiracetam.
Maltese: Levetiracetam Teva huwa mediċina li fiha s-sustanza attiva levetiracetam.
English: Epilepsy is caused by excessive electrical activity in the brain.
Maltese: L-epilessija hija kkawżata minn ħafna attività elettrika fil-moħħ.
English: Because Levetiracetam Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Levetiracetam Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, jitqies li l-benefiċċji u r-riskji tiegħu huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Levetiracetam Teva can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Maltese: Levetiracetam Teva jista' jintuża waħdu f'pazjenti minn 16-il sena 'l fuq li ġew dijanjostikati għallewwel darba bl-epilessija, għall-kura ta' aċċessjonijiet parzjali tal-bidu (attakki ta' epilessija) b'ġeneralizzazzjoni sekondarja jew mingħajrha.
English: 100 capsules
Maltese: 100 kapsula
English: 200 mg Capsule, hard
Maltese: 200 mg Kapsula, iebsa
English: Bottle (glass)
Maltese: Flixkun (ħġieġ)
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 90 (3 x 30) tablets
Maltese: 90 (3 x 30) pilloli
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Numru tal-MA (EU) Isem (ivvintat)
English: Wessling Hungary Kft Fòti ùt 56, Budapest 1047, Hungary
Maltese: Wessling Hungary Kft Fòti ùt 56, Budapest 1047, L-Ungerija
English: Warfarin and dipyridamole
Maltese: Warfarin u dipyridamole
English: 30 days
Maltese: 30 jum
English: 0.034a a: Pearson's chi-square test of difference between placebo and eptifibatide.
Maltese: 0.034a a: Test chi square ta' Pearson tad-differenza bejn plaċebo u eptifibatide.
English: Emergency or semi-elective surgery
Maltese: Operazzjoni ta' emerġenza jew operazzjoni semi-elettiva
English: 319, Pinner Road, Harrow Middlesex HA1 4HF United Kingdom
Maltese: 319, Pinner Road, Harrow Middlesex HA1 4HF
English: The placebo arm was comparable (aspirin 99.7 %, clopidogrel 95.9 %, ticlopidin 2.6 %).
Maltese: Il-grupp tal-plaċebo kien komparabbli (aspirin 99.7 %, clopidogrel 95.9 %, ticlopidine 2.6 %).
English: A target aPTT of 50-70 seconds was recommended.
Maltese: Kien irrakkomandat targit ta' aPTT ta' 50-70 sekondi.
English: ESPRIT trial
Maltese: Prova ESPRIT
English: Thrombocytopenia.
Maltese: Tromboċitopenija.
English: - prothrombin time > 1.2 times control, or International Normalized Ratio (INR) ≥ 2.0
Maltese: − ħin ta' prothrombin > 1.2 darbiet dak tal-kontroll, jew Proporzjon Normalizzat Internazzjonali (INR) ta' ≥ 2.0
English: Nervous System disorders
Maltese: Disturbi fis-Sistema Nervuża
English: ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with eptifibatide Therapy) was a double-blind, randomised, placebo-controlled trial (n= 2,064) for nonurgent PCI with intracoronary stenting.
Maltese: ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with Eptifibatide Therapy) kienet prova double-blind, randomised, ikkontrollata bil-plaċebo (n= 2,064) għall-PCI mhux urġenti bi stenting intrakoronarju.
English: Clinical Trials
Maltese: Provi kliniċi
English: − The active substance is eptifibatide.
Maltese: − Is-sustanza attiva hi eptifibatide.
English: The active substance is eptifibatide.
Maltese: Is-sustanza attiva hi eptifibatide.
English: - sudden, severe allergic reaction.
Maltese: − reazzjoni allerġika severa f'daqqa.
English: Date of first authorisation: 11th January 2016
Maltese: Data ta' l-ewwel awtorizzazzjoni:11th Jannar 2016
English: The ESPRIT trial used a simplified regimen of heparin during PCI that consisted of an initial bolus of 60 units/kg, with a target ACT of 200 - 300 seconds.
Maltese: Il-prova ESPRIT użat kors simplifikat ta' heparin waqt il-PCI li kien jikkonsisti f'bolus inizjali ta' 60 unità/kg, b'targit ta' ACT ta' 200 - 300 sekonda.
English: Fatal bleeding (the majority involved central and peripheral nervous system disorders: cerebral or intracranial haemorrhages); pulmonary haemorrhage, acute profound thrombocytopenia, haematoma.
Maltese: Fsada fatali (il-maġġoranza kienet tinvolvi disturbi ċentrali u periferali fissistema nervuża: emorraġiji ċerebrali jew fil-kranju); emorraġija pulmonari, tromboċitopenija akuta profonda, ematoma.
English: 2 mg/ml : 3.45 mg/ml (0.150 mmol/ml) sodium For the full list of excipients, see section 6.1.
Maltese: 2 mg/ml : 3.45 mg/ml (0.150 mmol/ml) ta' sodju
English: Similar differences were noted for TIMI major haemorrhage (118 [2.5 %] in early routine use vs. 83 [1.8 %] in delayed provisional use; p=0.016).
Maltese: Differenzi jixxiebhu ġew innutati għal emorraġija kbira TIMI (118 [2.5%] f'użu bikri ta' rutina vs. 83 [1.8%] b'użu provviżorju mdewwem; p=0.016).
English: Eptifibatide Accord is not compatible with furosemide.
Maltese: Eptifibatide Accord mhux kompatibli ma' furosemide.
English: The vast majority of patients received acetylsalicylic acid (75-325 mg once daily).
Maltese: Il-maġġoranza l-kbira tal-pazjenti rċevew acetylsalicylic acid (75-325 mg darba kuljum).
English: Table 1: Incidence of Death/CEC-Assessed MI («Treated as Randomised» Population)
Maltese: Tabella 1: Inċidenza ta' Mewt/MI Vvalutata minn CEC (Popolazzjoni «Li Titqies bħala Randomizzata»)
English: Eptifibatide Accord is chemically and physically compatible with 0.9 % sodium chloride solution for infusion and with dextrose 5 % in Normosol R with or without potassium chloride up to 92 hours when stored at 20-25°C.
Maltese: Accord huwa kimikament u fiżikament kompatibbli ma' soluzzjoni għall-infużjoni ta' 0.9 % sodium chloride u ma' 5 % dextrose f'Normosol R, bi jew mingħajr potassium chloride sa 92 siegħa meta jinħażen f'temperatura ta' 20-25°C.
English: - Keep this leaflet.
Maltese: - infjammazzjoni ta' vina.
English: Eptifibatide Accord 2 mg/ml solution for injection contains 57.96 mg (2.52 mmol) of sodium per maximum daily dose.
Maltese: Sodju Eptifibatide Accord 2 mg soluzzjoni għall-injezzjoni fih 57.96 mg (2.52 mmol) ta' sodju għal kull doża massima ta' kuljum.
English: Distrobution
Maltese: Distribuzzjoni
English: Patients were randomised to either placebo, eptifibatide 180 microgram/kg bolus followed by a 2.0 microgram/kg/min infusion (180/2.0), or eptifibatide 180 microgram/kg bolus followed by a 1.3 microgram/kg/min infusion (180/1.3).
Maltese: Il-pazjenti kienu randomised għall-plaċebo, bolus ta' 180 mikrogramma/kg ta' eptifibatide segwit minn infużjoni ta' 2.0 mikrogrammi/kg/min (180/2.0), jew bolus ta' 180 mikrogramma/kg ta' eptifibatide segwit minn infużjoni ta' 1.3 mikrogrammi/kg/min (180/1.3).
English: Thrombocytopenia and Immunogencity related to GP IIb/IIIa inhibitors
Maltese: Tromboċitopenija u Immunoġeniċità relatati ma' inibituri ta' GP IIb/IIIa
English: 0.75 mg/ml : 1.72 mg/ml (0.075 mmol/ml) sodium For the full list of excipients, see section 6.1.
Maltese: 0.75 mg/ml : 1.72 mg/ml (0.075 mmol/ml) ta' sodju
English: The rate of infusion was 2.0 microgram/kg/min for patients with serum creatinine ≤ 175 micromols/l or 1.0 microgram/kg/min for serum creatinine > 175 up to 350 micromols/l.
Maltese: Ir-rata ta' l-infużjoni kienet ta' 2.0 mikrogrammi/kg/min għall-pazjenti bi krejatinina fis-serum ta' ≤ 175 mikromols/l jew ta' 1.0 mikrogramma/kg/min għall-krejatinina fis-serum ta' > 175 sa 350 mikromols/l.
English: I.V.
Maltese: A.
English: Eptifibatide Accord 0.75 mg/ml solution for infusion contains 77.4 mg (3.37 mmol) of sodium per maximum daily dose.
Maltese: Eptifibatide Accord 0.75 mg soluzzjoni għall-infużjoni fih 77.4 mg (3.37 mmol) ta' sodju għal kull doża massima ta' kuljum.
English: Uncommon side effects
Maltese: Effetti sekondarji komuni
English: EARLY ACS (Early Glycoprotein IIb/IIIa Inhibition in Non-ST-segment Elevation Acute Coronary Syndrome) was a study of early routine eptifibatide versus placebo (with delayed provisional use of eptifibatide in the catheterization laboratory) used in combination with antithrombotic therapies (ASA, UFH, bivalirudin, fondaparinux or low molecular weight heparin), in subjects with high-risk NSTE ACS.
Maltese: Il-prova EARLY-ACS EARLY ACS (Impediment Bikri tal-Glikoproteina IIb/IIIa f'Sindrome Koronarju Akut b'Elevazzjoni tas-segment li Mhux ST) kien studju ta' għoti bikri ta' eptifibatide bħala rutina versus plaċebo (b'użu provviżorju mdewwem ta' eptifibatide fil-laboratorju ta' kateterizzazzjoni) użati flimkien ma' terapiji antitrombotiċi (ASA, UFH, bivalirudin, fondaparinux jew heparin b'piż molekulari baxx), f'individwi b'riskju għoli ta' NSTE ACS.
English: Eptifibatide Accord is an inhibitor of platelet aggregation.
Maltese: Eptifibatide Accord huwa impeditur ta' l-aggregazzjoni tal-plejtlits.
English: Eptifibatide and thrombolytic agents
Maltese: Eptifibatide u sustanzi trombolitiċi
English: The primary endpoint of the trial was death (D), MI, urgent target vessel revascularisation (UTVR), and acute antithrombotic rescue with GP IIb/IIIa inhibitor therapy (RT) within 48 hours of randomisation.
Maltese: MI, urgent target vessel revascularisation (UTVR), u salvataġġ antitrombotiku akut b'terapija ta' impeditur ta' GP IIb/IIIa (RT) sa 48 siegħa mir-randomisation.
English: In a post hoc analysis of the EARLY ACS trial the risk benefit of dose reduction in patients with moderate renal impairment is inconclusive.
Maltese: F'analiżi post hoc tal-prova EARLY ACS l-benefiċċji u r-riskji ta' tnaqqis fid-doża f'pazjenti b'indeboliment renali moderat ma kienux konklussivi.
English: − fatal bleeding.
Maltese: - fsada fatali.
English: Cardiac arrest, ventricular fibrillation, ventricular tachycardia, congestive heart failure, atrioventricular block, atrial fibrillation.
Maltese: Waqfien tal-qalb, fibrillazzjoni ventrikulari, takikardija ventrikulari, insuffiċjenza konġestiva tal-qalb, imblokk atrijoventrikulari, fibrillazzjoni atrijali.
English: The activated partial thromboplastin time (aPTT) must be monitored in order to maintain a value between 50 and 70 seconds, above 70 seconds there may be an increased risk of bleeding.
Maltese: Il-ħin ta' thromboplastin parzjali attivat (activated partial thromboplastin time)(aPTT) irid ikun osservat sabiex jinżamm valur ta' bejn 50 u 70 sekonda; jista' jkun hemm riskju miżjud ta' fsada 'l fuq minn 70
English: However, in a population pharmacokinetic study there was no evidence of a pharmacokinetic interaction between eptifibatide and the following concomitant medicinal products: amlodipine, atenolol, atropine, captopril, cefazolin, diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, and warfarin.
Maltese: atropine, captopril, cefazolin, diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, u warfarin.
English: • or increased CK-MB.
Maltese: • jew żjieda ta' CK-MB.
English: Citric acid monohydrate Sodium hydroxide Water for injections
Maltese: Citric acid monohydrate Sodium hydroxide Ilma għall-injezzjonijiet
English: Compared to placebo, eptifibatide administered as 180/2.0 significantly reduced the incidence of the primary endpoint events (table 1): this represents around 15 events avoided for 1,000 patients treated:
Maltese: Imqabbel mal-plaċebo, eptifibatide mogħti bħala 180/2.0 naqqas b'mod sinifikanti l-inċidenza tal-punt finali primarju (tabella 1): dan jirrappreżenta madwar 15-il avveniment li kienu evitati għal 1,000
English: The expiry date refers to the last day of that month.
Maltese: Il-waqfien tat-treddigħ waqt il perijodu ta' kura huwa rrakkomandat.
English: Other medicines and Eptifibatide Accord
Maltese: Mediċini oħra u Eptifibatide Accord
English: The most common bleeding complications were associated with cardiac invasive procedures (coronary artery bypass grafting (CABG)-related or at femoral artery access site).
Maltese: proċeduri kardijaċi invażivi (relatati ma' coronary artery bypass grafting (CABG) jew fis-sit ta' aċċess ta' l-arterja femorali).
English: Eptifibatide Accord 2 mg/ml: Each ml of solution for injection contains 2 mg of eptifibatide.
Maltese: Eptifibatide Accord 2 mg/ml: Kull ml ta' soluzzjoni għall-infużjoni fih 2 mg ta' eptifibatide.
English: If Percutaneous Coronary Intervention (PCI) is performed during eptifibatide therapy, continue the infusion for 20-24 hours post-PCI for an overall maximum duration of therapy of 96 hours.
Maltese: Jekk ikun imwettaq Intervent Koronarju Perkutanju (PCI) waqt it-terapija b'eptifibatide, kompli l-infużjoni għal 20-24 siegħa wara l-PCI għal tul totali massimu tat-terapija ta' 96 siegħa.
English: Excipients: Citric acid monohydrate, sodium hydroxide, water for injections.
Maltese: Eċċipjenti: Citric acid monohydrate, sodium hydroxide, ilma għall-injezzjonijiet.
English: No apparent differences were observed between patients treated with eptifibatide or with placebo in values for liver function (SGOT/AST, SGPT/ALT, bilirubin, alkaline phosphatase) or renal function (serum creatinine, blood urea nitrogen).
Maltese: Ma kienet osservata l-ebda differenza evidenti bejn pazjenti kkurati b'eptifibatide u dawk bil-plaċebo fil-valuri tal-funzjoni tal-fwied (SGOT/AST, SGPT/ALT, bilirubin, alkaline phosphatase) jew tal-funzjoni tal-kliewi (krejatinina fis-serum, nitroġenu bħala ureja fid-demm).
English: MI could also be reported following CEC adjudication of an investigator report.
Maltese: MI seta' wkoll ikun irrappurtat wara l-ġudizzju tas-CEC ta' rapport ta' l-investigatur.
English: Solution for infusion 100 ml
Maltese: 100 ml
English: Eptifibatide, a synthetic cyclic heptapeptide containing six amino acids, including one cysteine amide and one mercaptopropionyl (desamino cysteinyl) residue, is an inhibitor of platelet aggregation and belongs to the class of RGD (arginine-glycine-aspartate)-mimetics.
Maltese: Eptifibatide, li huwa eptapeptid ċikliku sintetiku li fih sitt aċidi amminiċi, li jinkludu cysteine amide wieħed u residwu ta' mercaptopropionyl (desamino cysteinyl) wieħed, huwa impeditur ta' laggregazzjoni tal-plejtlits u jappartieni għall-klassi ta' mimetiċi ta' RGD (arginine-glycine-aspartate).
English: The primary endpoint event rate was 11.9 % in patients who received a reduced dose (1microgram/kg/min) vs 11.2 % in patients who received the standard dose (2 microgram/kg/min) when eptifibatide was administered in the early routine fashion (p=0.81).
Maltese: 11.9% f'pazjenti li rċevew doża mnaqqsa (1 mikrogramma/kg/min) vs 11.2% f'pazjenti li rċevew doża standard (2 mikrogrammi/kg/min) meta eptifibatide ingħata f'rutina bikrija (p = 0.81).
English: On the day of PCI, prior to catheterization, 53.2 % received a thienopyridine (clopidogrel 52.7 %; ticlopidine 0.5 %) - mostly as a loading dose (300 mg or more).
Maltese: Fil-jum tal-PCI, qabel il-proċess tad-dħul tal-kateter, 53.2 % irċevew thienopyridine (clopidogrel 52.7 %; ticlopidine 0.5 %) - il-biċċa l-kbira bħala doża għolja tal-bidu (300 mg jew iżjed).
English: Early routine eptifibatide in this high-risk NSTE-ACS optimally-treated population who were managed with an invasive strategy did not result in a statistically significant reduction in the composite primary endpoint of rate of death, MI, RI-UR, and TBO within 96 hours compared with a regimen of delayed provisional eptifibatide (9.3 % in early eptifibatide patients vs. 10.0 % in patients assigned to delayed provisional eptifibatide; odds ratio=0.920; 95 % CI=0.802-1.055; p=0.234).
Maltese: 0% f'pazjenti li kienu assenjati għal għoti provviżorju mdewwem ta' eptifibatide; proporzjon ta' probabbiltà =0.920; 95% CI=0.802-1.055; p=0.234). Fsada GUSTO
English: One 10 ml vial contains 20 mg of eptifibatide.
Maltese: Kunjett wieħed ta' 10 ml fih 20 mg ta' eptifibatide.
English: Arterial procedures
Maltese: Proċeduri arterjali
English: This recommendation is based on pharmacodynamic and pharmacokinetic data.
Maltese: Din ir-rakkomandazzjoni hija bbażata fuq dejta farmakodinamika u farmakokinetika.
English: Bleeding events were more frequent in patients receiving concurrent heparin while undergoing PCI, when ACT exceeded 350 seconds (see section 4.4, heparin use).
Maltese: Avvenimenti ta' fsada kienu aktar spissi f'pazjenti li kienu qed jirċievu wkoll heparin waqt li kienu sottoposti għall-PCI, meta l-ACT qabeż it-350 sekonda (ara sezzjoni 4.4, l-użu ta' heparin).
English: UA/NQMI: For a patient who weighs ≥ 70 kg, it is recommended that a bolus dose of 5,000 units is given, followed by a constant intravenous infusion of 1,000 units/hr.
Maltese: Għal pazjent li jiżen ≥ 70 kg, huwa rrakkomandat li tingħata doża bolus ta' 5,000 unità, segwita minn infużjoni kontinwa fil-vini ta' 1,000 unità/hr.
English: Eptifibatide Accord 2 mg/ml solution for injection eptifibatide
Maltese: Eptifibatide Accord 2 mg/ml soluzzjoni għall-injezzjoni eptifibatide
English: • either ST-segment changes: ST depression > 0.5 mm of less than 30 minutes or persistent ST elevation > 0.5 mm not requiring reperfusion therapy or thrombolytic agents, T-wave inversion (> 1 mm),
Maltese: • bidliet fis-setturi ST: tnaqqis ta' > 0.5 mm ta' ST ta' inqas minn 30 minuta jew elevazzjoni persistenti ta' > 0.5 mm ta' ST li ma kinetx teħtieġ terapija ta' restawrazzjoni taċ-ċirkolazzjoni tad-demm jew sustanzi trombolitiċi, inverżjoni tal-mewġa T (> 1 mm),
English: The pharmacokinetics of eptifibatide are linear and dose proportional for bolus doses ranging from 90 to 250 microgram/kg and infusion rates from 0.5 to 3.0 microgram/kg/min.
Maltese: Assorbiment Il-farmakokinetika ta' eptifibatide hija lineari u proporzjonjali mad-doża għal dożi bolus li jvarjaw minn 90 sa 250 mikrogramma/kg u rati ta' infużjoni minn 0.5 sa 3.0 mikrogrammi/kg/min.
English: Unfractionated heparin was administered intravenously or subcutaneously at the physician's discretion, most commonly as an intravenous bolus of 5,000 U followed by a continuous infusion of 1,000 U/h.
Maltese: Heparin mhux frazzjonat kien mogħti fil-vini jew taħt il-ġilda skond id-diskrezzjoni tat-tabib, l-aktar mod komuni bħala bolus ta' 5,000 U fil-vini segwit minn infużjoni kontinwa ta' 1,000 U/h.
English: Cerebral ischaemia.
Maltese: Iskemija ċerebrali.
English: Eptifibatide Accord is an antithrombotic agent that acts by inhibition of platelet aggregation; therefore the patient must be observed carefully for indications of bleeding during treatment (see section 4.8).
Maltese: Eptifibatide Accord huwa sustanza antitrombotika li taġixxi permezz ta' l-impedizzjoni ta' laggregazzjoni tal-plejtlits; għalhekk il-pazjent għandu jkun osservat b'attenzjoni għal indikazzjonijiet ta' fsada waqt il-kura (ara sezzjoni 4.8).
English: During treatment with eptifibatide in this study, minor bleeding was a very common complication (> 1/10, or 13.1 % for eptifibatide versus 7.6 % for placebo).
Maltese: Waqt kura b'eptifibatide f'dan l-istudju, fsada minuri kien komplikazzjoni komuni ħafna (>1/10, jew 13.1% għal eptifibatidekontra 7.6% għall-plaċebo).
English: Vascular Disorders
Maltese: Disturbi Vaskulari
English: It is usually given with aspirin and unfractionated heparin.
Maltese: Ġeneralment jingħata flimkien mal-aspirina u heparin mhux frazzjonat.
English: The need for blood transfusions was increased modestly by eptifibatide treatment (11.8 % versus 9.3 % for placebo).
Maltese: Il-ħtieġa ta' trasfużjonijiet tad-demm żdiedet kemmxejn bil-kura ta' eptifibatide (11.8% kontra 9.3% għall-plaċebo).
English: In the subgroup of patients undergoing PCI, major bleeding was observed commonly, in 9.7 % of eptifibatide -treated patients vs. 4.6 % of placebo-treated patients.
Maltese: Fis sottogrupp ta' pazjenti li għamlu PCI, fsada maġġuri kienet osservata b'mod komuni, f'9.7 % tal pazjenti kkurati b'eptifibatide vs. 4.6 % tal-pazjenti kkurati bil-plaċebo.
English: One 100 ml vial contains 75 mg of eptifibatide.
Maltese: Kunjett ta' 100 ml fih 75 mg ta' eptifibatide.
English: Of the patients in PURSUIT, 13 % were managed with PCI during eptifibatide infusion, of whom approximately 50 % received intracoronary stents; 87 % were managed medically (without PCI during eptifibatide infusion).
Maltese: Mill-pazjenti ta' PURSUIT, 13 % kienu mmaniġġjati b'PCI waqt l-infużjoni ta' eptifibatide, li minnhom madwar 50 % irċivew stents intrakoronarji; 87 % kienu mmaniġġjati b'mod mediku (mingħajr PCI waqt l-infużjoni ta' eptifibatide).
English: In patients with moderate renal impairment, (creatinine clearance 30 - 50 ml/min) 100 % inhibition was achieved at 24 hours following administration of 2 microgram/kg/min.
Maltese: F'pazjenti b'indeboliment renali moderat, (tneħħija tal-krejatinina 30 - 50 mL/min) inkisbet inibizzjoni ta' 100% fi żmien 24 siegħa wara għoti ta' 2 ug/kg/min.
English: Eptifibatide Accord 0.75 mg/ml solution for infusion: 100 ml vial, pack of one vial.
Maltese: Eptifibatide Accord 0.75 mg/ml soluzzjoni għall-infużjoni: kunjett ta' 100 ml, pakkett ta' kunjett wieħed.