FrancophonIA/ELRC3.0 huggingface dataset:
English: Nonclinical data performed with tenecteplase have shown bleeding with secondary mortality of dams due to the known pharmacological activity of the active substance and in a few cases abortion and resorption of the foetus occurred (effects only have been observed with repeated dose administration).
Maltese: Dejta mhix klinika li twettqet b'tenecteplase uriet ħruġ ta' demm b'mortalità sekondarja ta' annimali nisa minħabba l-attività farmakoloġika magħrufa tas-sustanza attiva, u fi ftit każijiet, abort u lassorbiment mill-ġdid tal-fetu seħħew (l-effetti ġew osservati biss bl-għoti ripetut tad-doża).
English: Metalyse belongs to a group of medicines called thrombolytic agents.
Maltese: Metalyse jappartjeni għall-grupp ta' mediċini msejħa sustanzi trombolitiċi.
English: The carton contains one vial with a lyophilised powder with 40 mg tenecteplase, one ready for use pre-filled syringe with 8 ml solvent, one vial adapter and one needle.
Maltese: Il-kaxxa tal-kartun fiha kunjett wieħed bi trab lijofilizzat li fih 40 mg tenecteplase, siringa waħda mimlija minn qabel lesta għall-użu bi 8 ml ta' solvent, adapter wieħed tal-kunjett u labra waħda.
English: In patients ≥ 75 years the observed incidence of the primary efficacy composite end point for the pharmaco-invasive strategy and primary PCI were as follows: before dose reduction 11/37 (29.7%) (95% CI: 15.9- 47.0) versus 10/32 (31.3%) (95% CI: 16.1-50.0), after dose reduction: 25/97 (25.8%) (95% CI: 17.4-35.7) versus 25/88 (24.8%) (95% CI: 19.3-39.0).
Maltese: F'pazjenti ta' ≥ 75 sena l-inċidenza osservata tal-punt aħħari tal-kompost tal-effikaċja primarja għallistrateġija farmakoinvażiva u l-PCI primarju kienu kif ġej: qabel it-tnaqqis fid-doża 11/37 (29.7%) (95% CI: 15.9- 47.
English: ** the incidence in the pharmaco-invasive group is as expected for fibrinolysis with tenecteplase (as observed in previous studies).
Maltese: ** l-inċidenza fil-grupp farmakoinvażiva hi kif mistennija għal fibrinolisi b'tenecteplase (kif osservat fl-istudji ta' qabel).
English: Each vial contains 10,000 units (50 mg) tenecteplase.
Maltese: Kull kunjett 1 fih 10,000 unità (50 mg) tenecteplase.
English: When reconstituted with 10 ml solvent each ml contains 1,000 U tenecteplase.
Maltese: solvent kull ml fih 1,000 U tenecteplase.
English: Tenecteplase is an intravenously administered, recombinant protein that activates plasminogen.
Maltese: Tenecteplase hu proteina rikombinanti li tingħata ġol-vina li tattiva l-plasminogen.
English: a bleeding disorder or tendency to bleed (haemorrhage) stroke (cerebrovascular event) very high, uncontrolled blood pressure a head injury severe liver disease a stomach ulcer (peptic ulcer) varicose veins in the gullet (oesophageal varices) abnormality of the blood vessels (e.g. an aneurysm) certain tumours inflammation of the lining around the heart (pericarditis); inflammation or infection of the heart valves (endocarditis) dementia;
Maltese: pressjoni tad-demm għolja ħafna li ma tkunx ikkontrollata korriment fir-ras mard sever tal-fwied ulċera ta' l-istonku (ulċera peptika) vini varikużi fil-gerżuma (variċi esofagali) anormalità tal-vini jew arterji (eż. anewriżmu) ċerti tumuri infjammazzjoni tal-kisja madwar il-qalb (perikardite); infjammazzjoni jew l-infezzjoni tal-valvoli tal-qalb (endokardite) dimenzja;
English: КГ - клон България
Maltese: KG Podružnica Ljubljana
English: It is recommended that antiarrhythmic therapy for bradycardia and/or ventricular tachyarrhythmias (pacemaker, defibrillator) is available when tenecteplase is administered.
Maltese: Hu rrakkommandat li t-terapija antiarritmijaka għall-bradikardija u/jew takijarritmiji ventrikulari (eż. pacemaker, defibrillatur) tkun disponibbli meta jingħata tenecteplase.
English: Arrhythmias
Maltese: Arritmiji
English: The carton contains one vial with a lyophilised powder with 50 mg tenecteplase, one ready for use pre-filled syringe with 10 ml solvent, one vial adapter and one needle.
Maltese: Il-kaxxa tal-kartun fiha kunjett wieħed bi trab lajofilizzat li fih 50 mg tenecteplaste, siringa waħda mimlija minn qabel lesta għall-użu b'10 ml ta' solvent, adapter wieħed tal-kunjett u labra waħda.
English: Composite death, shock, congestive heart failure, re-infarction
Maltese: Mewt komposta, xokk, insuffiċjenza konġestiva tal-qalb, infart mill-ġdid
English: Metalyse is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute myocardial infarction (AMI) symptoms.
Maltese: Metalyse huwa indikat għall-kura trombolitika f'adulti ta' infart mijokardjali ssuspettat flimkien ma' elevazzjoni persistenti tal-ST jew Bundle Branch Block tax-xellug riċenti fi żmien sitt sigħat wara lbidu tas-sintomi ta' l-infart mijokardjali akut (AMI).
English: PARTICULARS TO APPEAR ON THE INNER SIDE OF THE LID OF THE CARTON IN FORM OF A PICTOGRAMM
Maltese: DETTALJI LI JIDHRU FUQ IN-NAĦA TA' ĠEWWA TAL-GĦATU TAL-KAXXA TALKARTUN FIL-FORMA TA' PICTOGRAMM
English: Uncommon (may affect up to 1 in 100 people): irregular heart beat (reperfusion arrhythmias), sometimes leading to cardiac arrest.
Maltese: Mhux komuni (jistgħu jaffettwaw sa 1 minn kull 100 persuna): taħbit irregolarital-qalb(arritmiji ta' riperfużjoni),li kultantjistgħu jikkaġunaw arrest kardijaku.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65
Maltese: KG Birkendorfer Strasse 65
English: Significant bleeding disorder either at present or within the past 6 months Patients receiving effective oral anticoagulant treatment, e.g. warfarin sodium (INR > 1.3) (see section 4.4, subsection “Bleeding”)
Maltese: Mard ta' ħruġ ta' demm sinifikanti fil-preżent jew fl-aħħar 6 xhur Pazjenti li jkunu qed jirċievu kura orali b'mediċini kontra l-koagulazzjoni, eż. warfarin sodium (INR > 1.3) (ara sezzjoni 4.4, sottosezzjoni “Ħruġ ta' demm”) Kwalunkwe storja medika ta' ħsara fis-sistema nervuża ċentrali (i.e. neoplażma, anewriżmu, operazzjoni intrakranjali jew fil-kolonna vertebrali).
English: Single components of the primary composite endpoint for the pharmaco-invasive strategy versus primary PCI respectively were observed with the following frequencies:
Maltese: Komponenti waħidhom tar-riżultat aħħari tal-kompost primarju għall-istrateġija farmakoinvażiva kontra PCI primarju rispettivament ġew osservati bil-frekwenzi li ġejjin: Farmakoinvażivi (n=944)
English: one vial of 8,000 units Metalyse powder and one pre-filled syringe containing 8 ml water for injections
Maltese: kunjett wieħed ta' 8,000 unità ta' trab ta' Metalyse u siringa waħda mimlija għal-lest li fiha 8 ml ilma għall-injezzjonijiet
English: Intracranial haemorrhage after protocol amendment to half dose in patients ≥ 75 years : * the incidences in both groups are those expected in STEMI patients treated by fibrinolytics or primary PCI (as observed in previous studies).
Maltese: Emorraġija intrakranjali wara emenda tal-protokoll għal nofs doża f'pazjenti ta' ≥ 75 sena : * l-inċidenzi fiż-żewġ gruppi huma dawk mistennija f'pazjenti STEMI ikkurati minn fibrinolitiċi jew PCI primarju (kif osservat fl-istudji ta' qabel).
English: 1 vial of powder for solution for injection with 50 mg tenecteplase 1 pre-filled syringe with 10 ml of solvent for parenteral use
Maltese: Siringa 1 mimlija għal-lest fiha 10 ml ta' solvent Is-soluzzjoni rikostitwita fiha 1,000 unità (5 mg) ta' tenecteplase f'kull 1 ml.
English: Antifibrinolytic agents are available as a last alternative.
Maltese: Sustanzi antifibrinolitiċi huma disponibbli bħala laħħar alternattivi.
English: The ASSENT-4 PCI study was designed to show if in 4000 patients with large myocardial infarctions pre-treatment with full dose tenecteplase and concomitant single bolus of up to 4,000 IU unfractionated heparin administered prior to primary PCI to be performed within 60 to 180 minutes leads to better outcomes than primary PCI alone.
Maltese: PCI kien maħsub biex juri jekk fl-4,000 pazjent b'infarti mijokardjali kbar li seħħew qabel il-kura b'doża sħiħa ta' tenecteplase, u l-użu fl-istess ħin ta' bolus wieħed sa 4,000 IU ta' eparina mhux frazzjonata qabel PCI Primarju li jrid jitwettaq fi żmien 60 sa 180 minuta, iwassalx għal riżultati aħjar milli bil-PCI Primarju waħdu.
English: Known haemorrhagic diathesis
Maltese: Informazzjoni fuq il-perijodu tal-fetu mhix disponibbli.
English: After administration of tenecteplase dose dependent consumption of 2-antiplasmin (the fluid-phase inhibitor of plasmin) with consequent increase in the level of systemic plasmin generation have been observed.
Maltese: Wara l-għoti ta' tenecteplase, kien osservat konsum li jiddependi mid-doża ta' 2-antiplasmin (il-fażi tal-fluwidu ta' l-inibitur ta' plasmin) b'żieda konsegwenti fil-ġenerazzjoni tal-livell tal-plasmin sistemiku.
English: Renal and urinary disorders Common
Maltese: Ekimosi Disturbi fil-kliewi u fis-sistema urinarja Komuni
English: The trial was prematurely terminated with 1667 randomised patients due to a numerically higher mortality in the facilitated PCI group receiving tenecteplase.
Maltese: Il-prova kellha tintemm qabel il-waqt b'1,667 pazjenti randomised minħabba l-mortalità li kienet numerikament ogħla fil-grupp tal-PCI ffaċilitat, li fih il-pazjenti kienu qed jirċievu tenecteplase.
English: It binds to the fibrin component of the thrombus (blood clot) and selectively converts thrombus-bound plasminogen to plasmin, which degrades the fibrin matrix of the thrombus.
Maltese: Hu jeħel mal-komponent talfibrin tat-trombus (embolu tad-demm) u jibdel b'mod selettiv il-plasminogen li jkun imwaħħal ma' lembolu għal plasmin, li jiddegrada l-matriċi tal-fibrin ta' l-embolu.
English: Metalyse 8,000 units powder and solvent for solution for injection Tenecteplase
Maltese: Metalyse 8,000 unità ta' trab u solvent għal soluzzjoni għall-injezzjoni.
English: if you are taking tablets/capsules used to ”thin” the blood, such as warfarin or coumarin (anticoagulants); if you have an inflamed pancreas (pancreatitis); if you have recently had major surgery including surgery to your brain or spine; if you have been given cardiopulmonary resuscitation (chest compressions) for more than 2 minutes duration, in the last two weeks.
Maltese: jekk qed tieħu pilloli/kapsuli li jintużaw biex “iraqqu” d-demm, bħal warfarin jew coumarin (mediċini kontra t-tagħqid tad-demm); jekk għandek frixa infjammat (pankreatite); jekk dan l-aħħar kellek operazzjoni maġġuri li tinkludi operazzjoni f'moħħok jew fis-sinsla taddahar; jekk ingħatajt risuxitazzjoni kardjopulmonari (kompressjonijiet tas-sider) għal iktar minn 2 minuti, fl-aħħar ġimagħtejn.
English: Powder and solvent for solution for injection Tenecteplase
Maltese: Trab u solvent għal soluzzjoni għall-injezzjoni Tenecteplase
English: As with other thrombolytic agents, the followingevents have been reported as sequelae of myocardial infarction and/or thrombolytic administration:
Maltese: Bħal fil-każ ta' sustanzi trombolitiċi, il-każijiet li ġejjin ġew rapportati bħala sekwale għal infart mijokardjali u/jew l-għoti trombolitiku:
English: 1 vial of powder for solution for injection with 40 mg tenecteplase 1 pre-filled syringe with 8 ml of solvent for parenteral use
Maltese: U KONTENUT Kunjett 1 bit-trab għal soluzzjoni għall-injezzjoni li fih 40 mg tenecteplase Siringa 1 mimlija għal-lest li fiha 8 ml ta' solvent għall-użu permezz ta' tilqima
English: Medicinal products that affect coagulation or those that alter platelet function (e.g. ticlopidine, clopidogrel, LMWH) may increase the risk of bleeding prior to, during or after tenecteplase therapy.
Maltese: Prodotti mediċinali li jaffettwaw il-koagulazzjoni jew dawk li jibdlu l-funzjoni tal-plejtlets (eż. ticlopidine, clopidogrel, LMWH), jistgħu jżidu r-riskju ta' ħruġ ta' demm qabel, matul jew wara tterapija b'tenecteplase.
English: The STREAM study was designed to evaluate the efficacy and safety of a pharmaco-invasive strategy versus a strategy of standard primary PCI in patients presenting with ST elevation acute myocardial infarction within 3 hours of onset of symptoms not able to undergo primary PCI within one hour of first medical contact.
Maltese: L-istudju STREAM ġie maħsub biex jevalwa l-effikaċja u s-sigurtà ta' strateġija farmakoinvażiva kontra strateġija ta' PCI primarju standard f'pazjenti li jkollhom infart mijokardjali akut b'żieda f'ST fi żmien 3 sigħat mill-bidu tas-sintomi li ma jkunx jista' jsirilhom PCI primarju fi żmien siegħa millewwel kuntatt mediku.
English: Tenecteplase is a recombinant fibrin-specific plasminogen activator.
Maltese: Tenecteplase hu attivatur rikombinanti ta' plasminogen li hu speċifiku għal fibrin.
English: Patients who cannot undergo primary PCI within one hour as recommended by guidelines and receive tenecteplase as primary coronary recanalization treatment should be transferred without delay to a coronary intervention capable facility for angiography and timely adjunctive coronary intervention within 6-24 hours or earlier if medically indicated (see section 5.1 STREAM study).
Maltese: Pazjenti li ma jistax isirilhom PCI primarju fi żmien siegħa kif rakkomandat mil-linji gwida, u li jirċievu tenecteplase bħala kura għal rikanalizzazzjoni koronarja primarja għandhom jiġu ttrasferiti mingħajr dewmien f'faċilità li kapaċi tagħmel intervent koronarju għal anġjografija u intervent koronarju aġġuntiv f'waqtu fi żmien 6-24 siegħa jew iktar kmieni jekk ikun medikament indikat (ara sezzjoni 5.1, studju STREAM).
English: Each pre-filled syringe contains 10 ml solvent.
Maltese: Kull siringa 1 mimlija għal-lest fiha 10 ml ta' solvent.
English: Problem with the heart valve or heart lining (mitral valve incompetence, pericardial effusion) Blood clot in the veins (venous thrombosis)
Maltese: Problema bil-valv tal-qalb jew l-inforra tal-qalb (inkompetenza tal-valv mitrali, effużjoni perikardjali)
English: For intravenous use after reconstitution with 10 ml solvent
Maltese: Meta rikostitwita ma' 10 ml ta'
English: Trace residue from manufacturing process: Gentamicin
Maltese: Residwu f'ammonti traċċa mill-proċess ta' produzzjoni:
English: Patients' body weight category (kg)
Maltese: KG organizačná zložka
English: Antithrombotic adjunctive therapy with platelet inhibitors and anticoagulants should be administered according to the current relevant treatment guidelines for the management of patients with ST-elevation myocardial infarction.
Maltese: Terapija addizzjonali antitrombotika b'inibituri tal-plejtlets u mediċini kontra l-koagulazzjoni għandha tingħata skond il-linji gwida kurrenti rilevanti tal-kura għall-immaniġġar ta' pazjenti li għandhom infart mijokardjali b'elevazzjoni tal-ST.
English: Active peptic ulceration
Maltese: Ulċerazzjoni attiva ta' l-istonku
English: pericarditis, pulmonary oedema - uncommon: cardiac arrest, mitral valve incompetence, pericardial effusion, venous thrombosis,
Maltese: Embolu tad-demm fil-vini (trombożi venużi) Fluwidu bejn l-inforra tal-qalb u l-qalb (tamponade kardijaku) Tiċrit tal-muskolu kardijaku (tiċrit mijokardjali)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 10 ml water for injections
Maltese: INDIVIDWALI 10 ml ta' ilma għall-injezzjonijiet
English: For details see section 6.6: Special precautions for disposal and other handling
Maltese: Għad-dettalji ara sezzjoni 6.6: Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor
English: Patency data from the phase I and II angiographic studies suggest that tenecteplase, administered as a single intravenous bolus, is effective in dissolving blood clots in the infarct-related artery of subjects experiencing an AMI on a dose related basis.
Maltese: Madankollu, l-analiżi ta' informazzjoni minn iktar minn 12,000 pazjent li kienu kkurati matul fażi I, II u III, ma żvelat l-ebda interazzjonijiet klinikament rilevanti ma' prodotti mediċinali li jintużaw b'mod komuni f'pazjenti b'AMI u li jintużaw fl-istess ħin ma' tenecteplase.
English: Screw prefilled syringe in the vialadapter tightly.
Maltese: Labra sterili li tintuża darba biss.
English: one vial of 10,000 units Metalyse powder and one pre-filled syringe containing 10 ml water for injections.
Maltese: kunjett wieħed ta' 10,000 unità ta' trab ta' Metalyse u siringa waħda mimlija għal-lest li fiha 10 ml ilma għall-injezzjonijiet
English: 20 ml glass vial type I, with a coated (B2-42) grey rubber stopper and a flip-off cap filled with powder for solution for injection.
Maltese: Kunjett ta' 20 ml ta' ħġieġ ta' tip I, b'tapp tal-lastku griża miksi (B2-42) u għatu li jinfetaħ b'daqqa ta' saba' mimli bit-trab għal soluzzjoni għall-injezzjoni.
English: Each pre-filled syringe contains 8 ml solvent.
Maltese: INDIVIDWALI 8 ml ta' ilma għall-injezzjonijiet
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Metalyse 8,000 U
Maltese: U MNEJN GĦANDU JINGĦATA Solvent għal Metalyse 8,000 U
English: If primary percutaneous coronary intervention (PCI) is scheduled according to the current relevant treatment guidelines, tenecteplase (see section 5.1 ASSENT-4 study) should not be given.
Maltese: Jekk intervent koronarju perkutanju (PCI, percutaneous coronary intervention) primarju jkun skedat skont il-linji gwida ta' kura rilevanti kurrenti, tenecteplase (ara sezzjoni 5.1, studju ASSENT-4) m'għandux jingħata.
English: Date of first authorisation: 23 September 2009 Date of latest renewal: 14 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Settembru 2009 Data tal-aħħar tiġdid: 14 ta' Mejju 2014
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven Germany
Maltese: TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Il-Ġermanja
English: New cardiovascular events (primary endpoint) were prevented, with relative risk reductions of 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI: -26.9, 26.7), 6% (CI: -33.5, 34.3) and 14% (CI: -31.6, 44.2), during the 0-1, 1-3, 3-6, 6-9 and 9-12 month study intervals, respectively.
Maltese: Twaqqfu avvenimenti kardjovaskulari ġodda (punt primarju ta' tmien), bi tnaqqis fir-riskju relattiv ta' 22% (CI: 8.6, 33.4), 32% (CI: 12.8, 46.4), 4% (CI:26.9, 26.7), 6% (CI: -33.5, 34.3) u 14% (CI: -31.6, 44.2), waqt l-intervalli ta' studju ta' 0-1, 1-3, 3-6, 6-9 u 912 xhur, rispettivament.
English: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: KRKA d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: Blister of OPA/Alu/PVC-Alu containing 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 filmcoated tablets in the box.
Maltese: Folji ta' OPA/AL/PVC-Al li fihom 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 u 120 pillola miksija b'rita filkaxxa.
English: A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non- fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Maltese: It-total ta' 99.7% tal-pazjenti rċevew is-sustanzi fibrinolitiċi (speċifiċi ghallfibrin: 68.7%, mhux speċifiċi għall-fibrina: 31.1%), 89.5% heparin, 78.7% imblokkaturi tar-riċetturi beta, 54.7% l-inibituri ACE u 63% statins.
English: Boxes of 7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 film-coated tablets in blisters are available.
Maltese: Kaxxi disponibbli f'7, 14, 28, 30, 50, 56, 60, 84, 90, 100, 112 u 120 pillola miksija b'rita ġo folji.
English: 7 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 84 film-coated tablets 90 film-coated tablets 100 film-coated tablets 112 film-coated tablets 120 film-coated tablets
Maltese: 7 pilloli miksija b'rita 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 100 pillola miksija b'rita 112-il pillola miksija b'rita 120 pillola miksija b'rita
English: There have been a number of retrospective analyses, however, to evaluate this effect in patients treated with clopidogrel for whom there are genotyping results: CURE (n=2721), CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), and ACTIVE-A (n=601), as well as a number of published cohort studies.
Maltese: CHARISMA (n=2428), CLARITY-TIMI 28 (n=227), TRITON-TIMI 38 (n=1477), u ACTIVE-A (n=601), kif ukoll numru ta' studji ko-orti ppubblikati.
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)).
Maltese: In-numru ta' pazjenti li għaddew mill-punt primarju ta' tmiem [mewt kardjovaskulari (CV), infart mijokardijaku (MI) jew puplesija] kien 582 (9.3%) fil-grupp ikkurat bi clopidogrel u 719 (11.4%) fil-grupp ikkurat bil-plaċebo, li jissarraf fi tnaqqis fir-riskju relattiv ta' 20% (95% CI ta' 10%-28%; p=0.00009) għallgrupp ikkurat bi clopidogrel (tnaqqis fir-riskju relattiv ta' 17% f'pazjenti li kienu kkurati b'mod konservattiv, 29% meta kellhom anġoplastija koronarja transluminali perkutanja (PTCA) bi stent jew mingħajru u 10% meta kellhom trapjant ta' bajpass f'arterja koronarja (CABG)).
English: What Clopidogrel Krka contains - The active substance is clopidogrel.
Maltese: X'fih Clopidogrel Krka - Is-sustanza attiva hi clopidogrel.
English: How to take Clopidogrel Krka
Maltese: Tiħux Clopidogrel Krka
English: - carbamazepine a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer, - anti-retroviral medicines (medicines to treat HIV infections).
Maltese: - efavirenz, mediċina għat-trattament tal-infezzjonijiet mill-HIV (virus tal-immunodefiċjenza umana), - moclobemide, mediċina għat-trattament tad-dipressjoni, - repaglinide, mediċina għat-trattament tad-dijabete, - paclitaxel, mediċina għat-trattament tal-kanċer, - mediċini antiretrovirali (mediċini għall-kura ta' infezzjonijiet bl-HIV).
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel-treated group and 363 (5.8%) in the placebo-treated group].
Maltese: Dan il-benefiċċju ġie l-iktar mit-tnaqqis li kien statistikament sinifikanti ta' l-inċidenza ta' MI [287 (4.6%) fil-grupp ikkurat bi clopidogrel u 363 (5.8%) fil-grupp ikkurat bil-plaċebo].
English: Clopidogrel significantly reduced the relative risk of death from any cause by 7% (p=0.029), and the relative risk of the combination of re-infarction, stroke or death by 9% (p=0.002), representing an absolute reduction of 0.5% and 0.9%, respectively.
Maltese: Clopidogrel naqqas b'mod sinifikanti r-riskju relattiv tal-mewt minn kwalunkwe kawża b'7% (p=0.029), u rriskju relattiv ta' infart ġdid, puplesija jew il-mewt b'9% (p=0.002), li jirrappreżentaw tnaqqis assolut ta' 0.5% u 0.9%, rispettivament.
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1752) or placebo (n=1739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Maltese: Il-pazjenti rċevew clopidogrel (300 mg bħala d-doża qawwija inizjali segwita minn 75 mg /kuljum, n=1752) jew il-plaċebo (n=1739), it-tnejn ma' ASA (150 sa 325 mg bħala doża qawwija inizjali segwita minn 75 sa 162 mg/kuljum), sustanza fibrinolitika u, fejn kien xieraq, heparin.
English: - Active pathological bleeding such as peptic ulcer or intracranial haemorrhage.
Maltese: - Emorraġija patoloġika attiva bħal b'ulċera peptika jew emorraġija intrakranjali.
English: Patients received clopidogrel (75 mg/day, n=22,961) or placebo (n=22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge.
Maltese: Il-pazjenti ngħataw clopidogrel (75 mg/kuljum, n=22,961) jew il-plaċebo (n=22,891), flimkien ma' ASA (162 mg/kuljum), għal 28 jum jew sakemm ġew illiċenzjati millisptar.