FrancophonIA/ELRC3.0 huggingface dataset:
English: Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
Maltese: - Pazjenti li jkunu qegħdin jirċievu kimoterapija ta' remissjoni-induzzjoni għal lewkimja majeloġenuża akuta (AML) jew għal sindromi majelodisplastiċi (MDS) li jkunu mistennija li jikkawżaw newtropenija fit-tul u li jkunu f'riskju għoli li jiżviluppaw infezzjonijiet fungali invażivi;
English: Concomitant use of posaconazole and phenytoin and similar inducers (e.g. carbamazepine, phenobarbital, primidone) should be avoided unless the benefit to the patient outweighs the risk.
Maltese: użu fl-istess ħin ta' posaconazole u phenytoin u indutturi simili (eż. carbamazepine, phenobarbital, primidone)
English: b: In 1899 this was the period from randomization to last dose of study medicinal product plus 7 days; in 316
Maltese: b: Fi Studju 1899 dan kien il-perjodu mill-għażla aleatorja sal-aħħar doża tal-prodott mediċinali studjat u 7 ijiem aktar;
English: INFORMATION IN BRAILLE Posaconazole Accord 100 mg
Maltese: Jekk tinsa tieħu Posaconazole Accord
English: Stevens Johnson syndrome, vesicular rash Musculoskeletal and connective tissue disorders Uncommon:
Maltese: Disturbi muskolu-skeletrici u tattessuti konnettivi
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Maltese: darbiet akbar minn dak miksub b'mod terapewtiku.
English: Twenty patients received 200 mg daily dose and 210 patients received 300 mg daily dose (following twice daily dosing on Day 1 in each cohort).
Maltese: Għoxrin pazjent irċevew doża ta' 200 mg kuljum u 210 pazjenti rċevew doża ta' 300 mg kuljum (wara dożaġġ darbtejn kuljum f'Jum 1 f'kull grupp).
English: Elevated liver function tests were generally reversible on discontinuation of therapy and in some instances these tests normalised without interruption of therapy.
Maltese: It-testijiet għoljin tal-funzjoni tal- fwied kienu ġeneralment riversibbli wara li titwaqqaf it-terapija u f'xi każijiet dawn it-testijiet reġgħu lura għan-normal mingħajr ma twaqqfet it-terapija.
English: 200 mg four times daily (hospitalized) then 400 mg twice daily
Maltese: 200 mg tliet darbiet kuljum200 mg tliet darbiet kuljum200 mg erba' darbiet kuljum (dħul l-isptar)
English: blurred vision, photophobia, visual acuity reduced
Maltese: vista mċajpra, fotofobija, tnaqqis fl-akutezza tal-vista diplopja, skotoma
English: Calcium channel blockers metabolised through CYP3A4 (e.g. diltiazem, verapamil, nifedipine, nisoldipine)
Maltese: Imblokkaturi tal-kanali tal-kalċju metabolizzati permezz ta' CYP3A4
English: Posaconazole Accord should be administered with caution to patients with pro-arrhythmic conditions such as: - Congenital or acquired QTc prolongation - Cardiomyopathy, especially in the presence of cardiac failure - Sinus bradycardia - Existing symptomatic arrhythmias - Concomitant use with medicinal products known to prolong the QTc interval (other than those mentioned in section 4.3).
Maltese: L-għoti fl-istess ħin jista' jwassal għal żidiet fil-konċentrazzjonijiet fil- plażma ta' dawn ilprodotti mediċinali, li jwasslu għal titwil tal-QTc u inċidenzi rari ta' torsades de pointes (ara sezzjoni 4.3).
English: Q4 pCav: predicted Cav
Maltese: pCav:
English: The following medicines may decrease the effectiveness of Posaconazole Accord by decreasing the amount of Posaconazole Accord in the blood: - rifabutin and rifampicin (used to treat certain infections).
Maltese: Posaconazole Accord jista' possibbilment iżid ir-riskju ta' effetti sekondarji ta' xi mediċini oħra billi jżid lammont ta' dawn il-mediċini fid-demm.
English: Vistor hf.
Maltese: Vistor ehf.
English: PURSUIT trial
Maltese: Prova PURSUIT
English: Table 1
Maltese: Tabella 1:
English: Date of latest renewal: 09.07.2009
Maltese: Data ta' l-aħħar tiġdid: 09.07.2009
English: INTEGRILIN is not compatible with furosemide.
Maltese: INTEGRILIN mhux kompatibli ma' furosemide.
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 il-plaċebo u eptifibatide.
English: − thrombocytopenia (< 100,000 cells/mm3)
Maltese: − passat ta' dijatesi emorraġika − tromboċitopenija (< 100,000 ċellula/mm3)
English: GlaxoSmithKline Manufacturing S.P.A., Strada Provinciale Asolana No. 90, San Polo di Torrile 43056, Parma, Italy
Maltese: GlaxoSmithKline Manufacturing S.P.A., Strada Provinciale Asolana No. 90, San Polo di Torrile 43056, Parma, L-Italja
English: There were no notable differences observed with GUSTO severe bleeding rates.
Maltese: Ma kien hemm l-ebda differenza notevoli osservata b'rati severi ta' fsada GUSTO.
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: diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, and warfarin.
Maltese: cefazolin, diazepam, digoxin, diltiazem, diphenhydramine, enalapril, fentanyl, furosemide, heparin, lidocaine, lisinopril, metoprolol, midazolam, morphine, nitrates, nifedipine, u warfarin.
English: Frequencies are defined as 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).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: The primary endpoint analysis [quadruple composite of death, MI, urgent target vessel revascularisation (UTVR) and thrombolytic bail-out (TBO) at 48 hours] showed a 37 % relative and 3.9 % absolute reduction in the eptifibatide group (6.6 % events versus 10.5 %, p = 0.0015).
Maltese: L-analiżi tal-punt finali primarju [kombinat kwadruplu ta' mewt, MI, urgent target vessel revascularisation (UTVR) u salvataġg trombolitiku (TBO) fit-48 siegħa] uriet tnaqqis relattiv ta' 37 % u tnaqqis assolut ta' 3.9 % fil-grupp ta' eptifibatide (6.6 % avvenimenti kontra 10.5 %, p = 0.0015).
English: Glaxo Operations UK Ltd. (Trading as Glaxo Wellcome Operations) Harmire Road
Maltese: Glaxo Operations UK Ltd., (Fil-Kummerċ bħala Glaxo Wellcome Operations), Harmire Road, Barnard
English: − sudden, severe allergic reaction.
Maltese: − reazzjoni allerġika severa f'daqqa.
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: 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 sekonda.
English: − fatal bleeding.
Maltese: − fsada fatali.
English: haematuria, oral/oropharyngeal, haemoglobin/haematocrit decreased and other).
Maltese: demm, ematurja, orali/orofarinġali, tnaqqis fl-emoglobina/ematokrit u oħrajn).
English: Vascular Disorders Common
Maltese: Disturbi Vaskulari Komuni
English: related, gastrointestinal, genitourinary, retroperitoneal, intracranial, haematemesis,
Maltese: CABG, gastro-intestinali, genitourinarja, retroperitonali, fil-kranju, rimettar ta'
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: urgent target vessel revascularisation (UTVR), u salvataġġ antitrombotiku akut b'terapija ta' impeditur ta' GP IIb/IIIa (RT) sa 48 siegħa mir-randomisation.
English: GlaxoSmithKline Manufacturing S.P.A. Strada Provinciale Asolana No. 90 San Polo di Torrile 43056 Parma
Maltese: Strada Provinciale Asolana No. 90 San Polo di Torrile 43056
English: LIST OF EXCIPIENTS Citric acid monohydrate, sodium hydroxide, water for injections.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Citric acid monohydrate, sodium hydroxide, ilma għall-injezzjonijiet.
English: Take special care with Integrilin:
Maltese: M'għandekx tingħata Integrilin:
English: The extent of eptifibatide binding to human plasma protein is about 25 %.
Maltese: Il-grad ta' l irbit ta' eptifibatide mal-proteini tal-plażma umana huwa ta' madwar 25 %.
English: − Keep this leaflet.
Maltese: − infjammazzjoni ta' vina.
English: 1 vial of 100 ml
Maltese: Kunjett ta' 100 ml
English: 1 vial of 10 ml
Maltese: Kunjett ta' 10 ml
English: Barnard Castle
Maltese: Harmire Road Barnard Castle Co.
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: − severe renal impairment (creatinine clearance < 30 ml/min) or dependency on renal dialysis
Maltese: − indeboliment sever tal-kliewi (tneħħija tal-krejatinina < 30 ml/min) jew dipendenza fuq dijalisi talkliewi
English: INTEGRILIN is compatible with 0.9 % sodium chloride solution for infusion and with dextrose 5 % in Normosol R with or without potassium chloride.
Maltese: INTEGRILIN huwa kompatibbli ma' soluzzjoni għall-infużjoni ta' 0.9 % sodium chloride u ma' 5 % dextrose f'Normosol R, bi jew mingħajr potassium chloride.
English: Pharmacotherapeutic group: Antithrombotic agent (platelet aggregation inhibitors excl. heparin), ATC code: B01AC16
Maltese: Sustanza antitrombotika (impedituri ta' l-aggregazzjoni tal-plejtlits, ħlief heparin), Kodiċi ATC:
English: INTEGRILIN and thrombolytic agents
Maltese: INTEGRILIN u sustanzi trombolitiċi
English: Other medicines and Integrilin
Maltese: Mediċini oħra u Integrilin
English: − marked ECG changes (in particular ST-segment abnormalities)
Maltese: − bidliet sinifikanti fl-ECG (partikularment anormalitajiet fis-segment ta' ST)
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: 001). 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: INTEGRILIN is compatible with 0.9 % sodium chloride solution for injection and with dextrose 5 % in Normosol R with or without potassium chloride.
Maltese: INTEGRILIN huwa kompatibbli ma' soluzzjoni għall-injezzjoni ta' 0.9 % sodium chloride u ma' 5 % dextrose f'Normosol R, bi jew mingħajr potassium chloride.
English: Citric acid monohydrate
Maltese: 6.1 Lista ta' sustanzi mhux attivi Citric acid monohydrate Sodium hydroxide
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' l-aggregazzjoni tal-plejtlits u jappartieni għall-klassi ta' mimetiċi ta' RGD (arginine-glycine-aspartate).
English: − if you have been treated with another medicineof the same type as Integrilin.
Maltese: − jekk kont ikkurat b'mediċina oħra ta' l-istess tip ta' Integrilin.
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 (2microgram/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: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland Manufacturer:
Maltese: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, L- Irlanda Manifattur:
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 pazjent li kienu kkurati:
English: The need for blood transfusions was increased modestly by Integrilin treatment (11.8% versus 9.3% for placebo).
Maltese: Il-ħtieġa ta' trasfużjonijiet tad-demm żdiedet kemmxejn bil-kura ta' Integrilin (11.8% kontra 9.3% għall-plaċebo).
English: Manufacturer:
Maltese: PURSUIT:
English: When followed by a 2.0 microgram/kg/min continuous infusion, this regimen produces a > 80 % inhibition of ADP-induced ex vivo platelet aggregation, at physiologic calcium concentrations, in more than 80 % of patients.
Maltese: 2.0 mikrogrammi/kg/min, dan il-kors jipproduċi impedizzjoni ta' > 80 % ta' l-aggregazzjoni tal-plejtlits ex vivo kkaġunata minn ADP, f'konċentrazzjonijiet fiżjoloġiċi tal-kalċju, f'aktar minn 80 % tal-pazjenti.
English: One 100 ml vial contains 75 mg of eptifibatide.
Maltese: Kunjett wieħed ta' 100 ml fih 75 mg ta' eptifibatide.
English: > 110 mm Hg on antihypertensive therapy)
Maltese: Hg waqt terapija kontra l-pressjoni għolja)
English: Integrilin 0.75 mg/ml solution for infusion eptifibatide
Maltese: INTEGRILIN 0.75 mg/ml soluzzjoni għall-infużjoni eptifibatide
English: In an acute myocardial infarction study involving 181 patients, eptifibatide (in regimens up to a bolus injection of 180 microgram/kg, followed by an infusion up to 2 microgram/kg/min for up to 72 hours) was administered concomitantly with streptokinase (1.5 million units over 60 minutes).
Maltese: 180 mikrogramma/kg, segwita minn infużjoni sa 2 mikrogrammi/kg/min sa 72 siegħa) kien mogħti flimkien ma' streptokinase (1.5 miljun unità matul perijodu ta' 60 minuta).
English: MARKETING AUTHORISATION NUMBER EU/1/99/109/002
Maltese: FIS-SUQ EU/1/99/109/002
English: With delayed provisional eptifibatide administration, the TIMI major events were 1.4% vs 2.0% in patients who received reduced dose and standard dose respectively (p=0.54).
Maltese: B'għoti proviżorju ttardjat ta' eptifibatide, l-avvenimenti maġġuri TIMI kienu ta' 1.4 % vs 2.0% f'pazjenti li rċevew doża mnaqqsa u doża standard rispettivament (p = 0.54).
English: − persistent or recurrent ischemic cardiac pain
Maltese: − uġigħ kardijaku iskemiku persistenti jew rikorrenti
English: If either a confirmed platelet decrease to < 100,000/mm3 or acute profound thrombocytopaenia is observed, discontinuation of each treatment medication having known or suspected thrombocytopenic effects, including eptifibatide, heparin and clopidogrel, should be considered immediately.
Maltese: Jekk ikun osservat tnaqqis ikkonfermat tal-plejtlits għal < 100,000/mm3 jew tromboċitopenija akuta profonda, għandu jiġi kkunsidrat minnufih il-waqfien ta' kull mediċina li tikkura li għandha jew hemm suspett li għandha effetti tromboċitopeniċi, inkluż eptifibatide, heparin u clopidogrel.
English: During treatment with Integrilin in this study, minor bleeding was a very common complication (>1/10, or 13.1% for Integrilin versus 7.6% for placebo).
Maltese: Waqt kura b'Integrilin f'dan l-istudju, fsada minuri kien komplikazzjoni komuni ħafna (>1/10, jew 13.1% għal Integrilin kontra 7.6% għall-plaċebo).
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 talkateter, 53.2 % irċevew thienopyridine (clopidogrel 52.7 %; ticlopidine 0.5 %) - il-biċċa l-kbira bħala doża għolja tal-bidu (300 mg jew iżjed).
English: In patients with moderate renal impairment, (creatinine clearance 30 - 50mL/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 - 50mL/min) inkisbet inibizzjoni ta' 100% fi żmien 24 siegħa wara għoti ta' 2 ug/kg/min.
English: For this diagnosis, within 24 hours after the index PCI procedure, there had to be at least two CK-MB values ≥ 3 x the upper limit of normal; thus, validation by the CEC was not required.
Maltese: 24 siegħa wara il-proċedura PCI index, ried ikun hemm mill-inqas żewġ valuri ta' CK-MB ta' ≥ 3 x illimitu ta' fuq tan-normal; għalhekk, tisħiħ mis-CEC ma kienx meħtieġ.
English: Cardiac arrest, congestive heart failure, atrial fibrillation, hypotension, and shock, which are commonly reported events from the PURSUIT trial, were events related to the underlying disease.
Maltese: Waqfien tal-qalb, insuffiċjenza konġestiva tal-qalb, fibrillazzjoni atrijali, pressjoni baxxa, u xokk, li huma avvenimenti irrappurtati b'mod komuni fil-prova PURSUIT, kienu avvenimenti relatati mal-marda eżistenti minn qabel.
English: Toxicology studies conducted with eptifibatide include single and repeated dose studies in the rat, rabbit and monkey, reproduction studies in the rat and rabbit, in vitro and in vivo genetic toxicity studies, and irritation, hypersensitivity and antigenicity studies.
Maltese: studji dwar ir-riproduzzjoni fil-firien u fil-fniek, studji dwar it-tossiċità ġenetika in vitro u in vivo, u studji dwar l-irritazzjoni, is-sensittività eċċessiva u l-antiġeneċità.
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 published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott huma mniżżla fil lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor and other adhesive ligands to the glycoprotein (GP)IIb/IIIa receptors.
Maltese: fibrinoġen, tal-fattur von Willebrand u ta' ligandi oħra li jeħlu, mar-riċetturi tal-glikoproteini (GP) IIb/IIIa.
English: Sodium hydroxide
Maltese: Proċeduri arterjali
English: With delayed provisional eptifibatide administration, the event rates were 10% vs 11.5% in patients who received reduced dose and standard dose respectively (p=0.61).
Maltese: B'għoti proviżorju ttardjat ta' eptifibatide, ir-rati ta' avvenimenti kienu ta' 10% vs 11.5% f'pazjenti li rċevew doża mnaqqsa u doża standard rispettivament (p = 0.61 ).
English: Measurements of ADP-induced ex vivo platelet aggregation at physiologic calcium concentrations (Dphenylalanyl-L-prolyl-L-arginine chloromethyl ketone anticoagulant) in patients presenting with unstable angina and Non Q-Wave Myocardial Infarction showed a concentration-dependent inhibition with an IC50 (50 % inhibitory concentration) of approximately 550 ng/ml and an IC80 (80 % inhibitory concentration) of approximately 1,100 ng/ml.
Maltese: (Non-Q-Wave), wera impedizzjoni b'mod li jiddependi mill-konċentrazzjoni, b'IC50 (konċentrazzjoni li timpedixxi 50 %) ta' madwar 550 ng/ml u IC80 (konċentrazzjoni li timpedixxi 80 %) ta' madwar 1,100 ng/ml.
English: There is limited therapeutic experience with INTEGRILIN in patients for whom thrombolytic therapy is generally indicated (e.g. acute transmural myocardial infarction with new pathological Q-waves or elevated ST-segments or left bundle branch block in the ECG).
Maltese: Hemm esperjenza terapewtika limitata dwar l-użu ta' INTEGRILIN f'pazjenti li ġeneralment għandhom bżonn terapija trombolitika (eż. infart mijokardijaku transmurali akut b'mewġiet patoloġiċi tat-tip Q ġodda jew setturi ST (ST-segments) elevati jew imblokk tal-bundle branch tax-xellug fl-ECG).
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: L-aktar komplikazzjonijiet frekwenti ta' fsada kienu assoċjati ma' proċeduri kardijaċi invażivi (relatati ma' coronary artery bypass grafting (CABG) jew fis-sit ta' aċċess ta' l-arterja femorali).
English: What Integrilin looks like and contents of the pack Integrilin solution for infusion: 100 ml vial, pack of one vial.
Maltese: Integrilin soluzzjoni għall-infużjoni: kunjett ta' 100 ml, pakkett ta' kunjett wieħed.
English: Integrilin 2 mg/ml solution for injection eptifibatide
Maltese: INTEGRILIN 2 mg/ml soluzzjoni għall-injezzjoni eptifibatide
English: Results on the primary endpoint were mainly attributed to the reduction of enzymatic MI occurrence, identified as the occurrence of early elevation of cardiac enzymes after PCI (80 out of 92 MIs in the placebo group vs. 47 out of 56 MIs in the eptifibatide group).
Maltese: enzimatika, identifikata bħala l-okkorrenza ta' elevazzjoni bikrija ta' enzimi kardijaċi wara PCI (80 minn 92 MIs fil-grupp tal-plaċebo vs.
English: This study was a 726-center, 27-country, double-blind, randomised, placebo-controlled study in 10,948 patients presenting with UA or NQMI.
Maltese: Dan l-istudju kien jikkonsisti f'726 ċentru, 27 pajjiż, double-blind, randomised, ikkontrollat bil-plaċebo, u sar fuq 10,948 pazjent li kellhom UA jew NQMI. Il-pazjenti setgħu jkunu rreġistrati biss jekk kellhom iskemija kardijaka waqt li kienu jistrieħu (≥ 10 minuti) fl-aħħar 24 siegħa u kellhom:
English: INTEGRILIN is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.
Maltese: INTEGRILIN huwa maħsub għall-prevenzjoni ta' infart mijokardijaku bikri f'adulti li jbatu minn anġina mhux stabbli jew infart mijokardijaku tat-tip tal-mewġa li mhix Q (non-Q-wave), bl-aħħar episodju ta' uġigħ tas-sider li seħħ fl-aħħar 24 siegħa u b'bidliet fl-elettrokardjogramm (ECG) u/jew enzimi kardijaċi elevati.
English: − severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure
Maltese: − pressjoni għolja severa (pressjoni sistolika tad-demm ta' > 200 mm Hg jew pressjoni dijastolika taddemm ta' > 110 mm
English: Time
Maltese: Tqala
English: (> 1 mm),
Maltese: NUMRU(/I)
English: Each ml of solution for infusion contains 0.75 mg of eptifibatide.
Maltese: Kull ml ta' soluzzjoni għall-infużjoni fih 0.75 mg ta' eptifibatide.
English: The pivotal clinical trial for Unstable Angina (UA)/Non-Q Wave Myocardial Infarction (NQMI) was PURSUIT.
Maltese: Il-prova pivitali klinika għall-Anġina mhux Stabbli (UA)/Infart Mijokardijaku tat-tip Mhux tal-Mewġa Q (NQMI) kien PURSUIT.
English: MARKETING AUTHORISATION NUMBER EU/1/99/109/001
Maltese: EU/1/99/109/001