FrancophonIA/ELRC3.0 huggingface dataset:
English: The in-hospital mortality in a pool of randomized, clinical trials is summarized in the table below:
Maltese: L-inċidenza ta' mortalità fl-isptar f'ġabra ta' provi kliniċi randomised, hija miġbura fil-qosor fittabella taħt:
English: It has been observed that kaolin-based ACTs are not increased to the same degree by aprotinin as are diatomaceous earth-based (celite) ACTs.
Maltese: Kien osservat li ACTs ibbażati fuq kaolin ma jiżdidux bl-istess grad permezz ta' aprotinin kif huma ACTs ibbażati fuq diatomaceous earth (Celite).
English: Heparin levels during bypass should not be allowed to drop below 2.7 U/ml (2.0 mg/kg) or below the level indicated by heparin dose-response testing performed prior to administration of aprotinin.
Maltese: Livelli ta' heparin waqt il-bypass m'għandhomx jitħallew jinżlu taħt 2.7 U/ml (2.0 mg/kg) jew taħt il-livell indikat mill-ittestjar imwettaq qabel l-għoti ta' aprotinin dwar ir-rispons għad-doża tal-heparin.
English: The adverse reactions should be interpreted within the surgical setting.
Maltese: Ir-reazzjonijiet avversi għandhom ikunu interpretati f'ambjent kirurġiku.
English: Additional heparin should be administered on the basis of heparin levels measured by protamine titration.
Maltese: Heparin addizzjonali għandu jingħata fuq il-bażi tal-livelli tal-heparin imkejla permezz ta' titrazzjoni ta' protamine.
English: Animal studies did not provide any evidence of teratogenic or other embryotoxic effects of aprotinin.
Maltese: Studji fuq l-annimali ma pprovdew l-ebda evidenza ta' effetti teratoġeniċi jew ta' effetti embrijotossiċi oħra ta' aprotinin.
English: An increase in renal failure and mortality compared to age-matched historical controls has been reported for aprotinin-treated patients undergoing cardiopulmonary bypass with deep hypothermic circulatory arrest during operation of the thoracic aorta.
Maltese: Kienet irrappurtata żjieda fl-insuffiċjenza tal-kliewi u fil-mortalità meta mqabbel ma' kontrolli storiċi ta' l-istess età għall-pazjenti kkurati b'aprotinin li kienu qed jagħmlu bypass kardjopulmonari b'waqfien ipotermiku fil-fond taċ-ċirkolazzjoni matul operazzjoni tal-aorta toraċika.
English: A heparin dose response, assessed by protamine titration, should be performed prior to administration of aprotinin to determine the heparin loading dose.
Maltese: Titrazzjoni ta' protamine, li huwa metodu li mhux affettwat minn aprotinin, jista' jintuża biex jitkejlu l-livelli ta' heparin.
English: Adequate anticoagulation with heparin must be assured (see also above).
Maltese: Antikoagulazzjoni adegwata b'heparin għandha tiġi assigurata (ara wkoll hawn fuq).
English: Elevations in the partial thromboplastin time (PTT) and celite Activated Clotting Time (Celite ACT) are expected in aprotinin-treated patients during surgery, and in the hours after surgery.
Maltese: Żjidiet fil-ħin parzjali ta' thromboplastin (PTT) u fil-Ħin ta' Tagħqid Attivat minn celite (Celite ACT) huma mistennija f'pazjenti kkurat b'aprotinin waqt kirurġija, u fis-sigħat wara l-kirurġija.
English: Cardiac disorders
Maltese: Indeboliment epatiku
English: Pregnancy and breast-feeding
Maltese: Popolazzjoni pedjatrika
English: If you are pregnant or breast-feeding <Aprotinin-containing medicinal product> should only be used if your doctor/surgeon finds it will be of benefit.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib/kirurgu li se jagħtik <prodott mediċinali li fih
English: Immediate packaging Pack size
Maltese: Il-pakkett li jmiss mal-prodott Daqs talpakkett
English: MA (EU) number
Maltese: Mnejn għandu jingħata
English: Insulatard vial (100 international units/ml), Penfill and FlexPen:
Maltese: Kunjett ta' Insulatard (100 unità internazzjonali /ml) , Penfill u FlexPen:
English: Insulatard vial (40 international units/ml) EU/1/02/233/001
Maltese: Insulatard f'kunjett (40 unità internazzjonali/ml) EU/1/02/233/001
English: Suspension for injection Multipack: 5 packs of 1 x 10 ml vial
Maltese: Pakkett multiplu: 5 pakketti ta' kunjett 1 x 10 ml
English: Insulatard vial (40 international units/ml)/Insulatard vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.
Maltese: Insulatard f'kunjett (40 unità internazzjonali/ml)/ Insulatard f'kunjett (100 unità internazzjonali/ml) Kunjett (tal-ħġieġ ta'tip 1) magħluq b'disk (gomma tal-bromobutyl/polyisoprene) u b'għatu protettiv tal-plastik li jingħalaq b'sikurezza u li fih suspensjoni ta' 10 ml.
English: • Drink alcohol, see Insulatard with alcohol in section 2.
Maltese: • Tixrob l-alkoħol, ara Insulatard mal-alkoħol f'sezzjoni 2.
English: Insulatard contains sodium
Maltese: Insulatard fih sodium
English: Insulatard InnoLet EU/1/02/233/010 EU/1/02/233/011 EU/1/02/233/012
Maltese: EU/1/02/233/007 Insulatard InnoLet EU/1/02/233/010 EU/1/02/233/011
English: Insulatard FlexPen is a pre-filled disposable pen containing human insulin as isophane (NPH).
Maltese: Insulatard FlexPen Insulatard FlexPen hija pinna mimlija għal-lest li tintuża darba biss u li fiha insulina umana bħala isophane (NPH).
English: Insulatard contains less than 1 mmol sodium (23 mg) per dose, i.e. Insulatard is essentially ‘sodiumfree'.
Maltese: Insulatard fih inqas minn mmol 1 ta' sodium (23 mg) għal kull doża, i.e Insulatard huwa essenzjalment ‘bla sodium'.
English: Insulatard InnoLet is a pre-filled disposable pen containing human insulin as isophane (NPH).
Maltese: Insulatard InnoLet Insulatard InnoLet hija pinna mimlija għal-lest li tintuża darba biss u li fiha insulina umana bħala isophane (NPH).
English: Insulatard InnoLet 100 IU/ml Suspension for injection Insulin human
Maltese: Insulatard InnoLet 100 UI/ml Suspensjoni għall-injezzjoni Insulina umana
English: Component of a multipack, cannot be sold separately
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separat mill-kumplament
English: EU/1/02/233/013 1 pen of 3 ml EU/1/02/233/014 5 pens of 3 ml EU/1/02/233/015 10 pens of 3 ml
Maltese: EU/1/02/233/013 pinna 1 ta' 3 ml EU/1/02/233/014 5 pinen ta' 3 ml EU/1/02/233/015 10 pinen ta' 3 ml
English: Insulatard vial (40 international units/ml)/Insulatard vial (100 international units/ml) Administration with a syringe
Maltese: Insulatard f'kunjett (40 unità internazzjonali/ml)/Insulatard f'kunjett (100 unità internazzjonali/ml)
English: EU/1/02/233/010 1 pen of 3 ml EU/1/02/233/011 5 pens of 3 ml EU/1/02/233/012 10 pens of 3 ml
Maltese: EU/1/02/233/010 pinna 1 ta' 3 ml EU/1/02/233/011 5 pinen ta' 3 ml EU/1/02/233/012 10 pinen ta' 3 ml
English: EU/1/02/233/016 5 packs of 1 x 10 ml vial
Maltese: EU/1/02/233/016 5 pakketti ta' 1 x 10 ml
English: Insulatard with alcohol
Maltese: Insulatard mal-alkoħol
English: See your pen manual for further instructions.
Maltese: Ara l manwal tal-pinna għal aktar istruzzjonijiet.
English: Contents of the pack and other information What Insulatard contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Insulatard
English: Other medicines and Insulatard
Maltese: Mediċini oħra u Insulatard
English: Insulatard vial (100 international units/ml)
Maltese: Insulatard f'kunjett (100 unità internazzjonali/ml)
English: Insulatard vial (40 international units/ml)
Maltese: Insulatard f'kunjett (40 unità internazzjonali/ml)
English: Insulatard Penfill 100 international units/ml suspension for injection in cartridge.
Maltese: Insulatard Penfill 100 unità internazzjonali/ml suspensjoni għall-injezzjoni f'skartoċċ.
English: Changes in strength, brand (manufacturer), type, origin (animal insulin, human insulin or insulin analogue) and/or method of manufacture (recombinant DNA versus animal source insulin) may result in a need for a change in dose.
Maltese: Tibdil fil-qawwa, għamla (manifattur), tip, oriġini (insulina tal-annimali, insulina umana jew analogu tal-insulina ) u/jew metodu tal-manifattura (DNA rikombinanti kontra insulina li ġejja mill annimali) jista' jirriżulta fil-bżonn ta' tibdil fid-doża.
English: Insulatard Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: Insulatard Penfill hu magħmul biex jintuża ma' sistemi ta' għoti ta' insulina NovoNordisk u labar NovoFine jew NovoTwist.
English: Insulins and analogues for injection, intermediate-acting, insulin (human).
Maltese: Insulini u analogi għall-injezzjoni,
English: Your FlexPen is a pre-filled dial-a-dose insulin pen.
Maltese: ► F'pompi tal-infużjoni tal-insulina.
English: Insulatard Penfill EU/1/02/233/005 EU/1/02/233/006 EU/1/02/233/007
Maltese: EU/1/02/233/005 EU/1/02/233/006
English: Package leaflet: Information for the user Insulatard Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Maltese: Informazzjoni għall-utent Insulatard Penfill 100 UI/ml (unità internazzjonali/ml) suspensjoni għall-injezzjoni f'skartoċċ insulina umana
English: ► Insulatard Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Maltese: ► L-iskrataċ ta' Insulatard Penfill huma magħmula biex jintużaw mas-sistemi tal-għoti tal-insulina Novo Nordisk u mal-labar NovoFine jew NovoTwist.
English: EU/1/02/233/003 1 vial of 10 ml EU/1/02/233/004 5 vials of 10 ml
Maltese: EU/1/02/233/003 kunjett 1 ta' 10 ml EU/1/02/233/004 5 kunjetti ta' 10 ml
English: EU/1/02/233/001 1 vial of 10 ml EU/1/02/233/002 5 vials of 10 ml
Maltese: EU/1/02/233/001 kunjett 1 ta' 10 ml EU/1/02/233/002 5 kunjetti ta' 10 ml
English: Insulatard 40 international units/ml suspension for injection in vial.
Maltese: Insulatard 40 unità internazzjonali/ml suspensjoni għall-injezzjoni f'kunjett.
English: Insulatard is an isophane (NPH) human insulin suspension.
Maltese: Insulatard huwa suspensjoni ta' insulina umana isophane (NPH) Kull millilitru fih 40
English: Insulatard 100 international units/ml suspension for injection in vial.
Maltese: Insulatard 100 unità internazzjonali/ml suspensjoni għall-injezzjoni f'kunjett.
English: Insulatard FlexPen 100 international units/ml suspension for injection in pre-filled pen.
Maltese: Insulatard FlexPen 100 unità internazzjonali/ml suspensjoni għall-injezzjoni f'pinna mimlija għal-lest.
English: Package leaflet: Information for the user Insulatard 40 IU/ml (international units/ml) suspension for injection in vial human insulin
Maltese: Informazzjoni għall-utent Insulatard 40 UI/ml (unità internazzjonali/ml) suspensjoni għall-injezzjoni f'kunjett insulina umana
English: Insulatard vials are for use with insulin syringes with a corresponding unit scale.
Maltese: Il-kunjetti ta' Insulatard huma għall-użu ma' siringi tal-insulina bi skala korrispondenti ta' unitajiet.
English: Insulatard FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Maltese: Il-FlexPen hi magħmula biex tintuża mal-labar NovoFine jew NovoTwist li jintużaw darba biss u li għandhom tul ta' mhux iżjed minn 8 mm.
English: Insulatard vials are for use with insulin syringes with the corresponding unit scale.
Maltese: Il-kunjetti ta' Insulatard huma għall-użu ma' siringi tal-insulina bi skala ta' unitajiet korrispondenti.
English: Package leaflet: Information for the user Insulatard FlexPen 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Maltese: Informazzjoni għall-utent Insulatard FlexPen 100 UI/ml (unità internazzjonali/ml) suspensjoni għall-injezzjoni f'pinna mimlija għal-lest insulina umana
English: Insulatard is administered subcutaneously by injection in the thigh, the abdominal wall, the gluteal region or the deltoid region.
Maltese: Insulatard irid jiġi protett mis-sħana eċċessiva u mid-dawl.
English: Package leaflet: Information for the user Insulatard InnoLet 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Maltese: Informazzjoni għall-utent Insulatard 100 UI/ml (unità internazzjonali/ml) suspensjoni għall-injezzjoni f'kunjett insulina umana
English: ► Insulatard FlexPen is only suitable for injecting under the skin.
Maltese: ► Insulatard FlexPen huwa tajjeb biss għall-injezzjonijiet minn taħt il-ġilda.
English: How to store Insulatard
Maltese: Qabel ma tuża Insulatard
English: 9 March 2017
Maltese: 9 ta' Marzu 2017
English: It is also available under other trade names: Clexane, Clexane T, Clexane Forte, Klexane, Qualiop, Enoxaparin Sanofi and Enoxaparine Sanofi.
Maltese: Dan huwa disponibbli wkoll taħt ismijiet kummerċjali oħrajn: Clexane, Clexane T, Clexane Forte, Klexane, Qualiop, Enoxaparin Sanofi u Enoxaparine Sanofi.
English: What is Lovenox?
Maltese: X'inhu Lovenox?
English: Lovenox contains the active substance enoxaparin.
Maltese: Lovenox fih is-sustanza attiva enoxaparin.
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use of machines) and 4.8 (undesirable effects).
Maltese: Il-Kumitat armonizza wkoll sezzjonijiet oħrajn tal-SmPC inkluż sezzjonijiet 4.4 (twissijiet speċjali u prekawzjonijiet), 4.5 (interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni), 4.6 (fertilità, tqala u treddigħ), 4.7 (effetti fuq il-ħila biex issuq u tħaddem magni) u 4.8 (effetti mhux mixtieqa).
English: On 12 November 2015, France referred the matter to the CHMP in order to harmonise the marketing authorisations for Lovenox in the EU.
Maltese: Fit-12 ta' Novembru 2015, Franza rreferiet il-kwistjoni lis-CHMP sabiex jiġu armonizzati lawtorizzazzjonijiet għat-tqegħid fis-suq għal Lovenox fl-UE.
English: Patients at higher risk should be given 100 IU/kg (1 mg/kg) twice daily.
Maltese: Il-pazjenti li jinsabu f'riskju ogħla għandhom jingħataw 100 Iu/kg (1mg/kg) darbtejn kuljum.
English: On 15 December 2016, the European Medicines Agency completed a review of Lovenox and associated names.
Maltese: Fil-15 ta' Diċembru 2016, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Lovenox u ismijiet assoċjati.
English: 4.1 Therapeutic indications
Maltese: Indikazzjonijiet terapewtiċi
English: Lovenox is an anticoagulant medicine (a medicine to prevent blood clots) used in adults to prevent and treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg), as well as unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart) and certain types of myocardial infarction (heart attack);
Maltese: Lovenox huwa mediċina antikoagulanti (mediċina li tipprevjeni l-emboli tad-demm) li tintuża fl-adulti biex tipprevjeni u tikkura kondizzjonijiet assoċjati ma' emboli tad-demm bħal trombożi profonda fil-vini (fejn l-embolu jiżviluppa f'vina profonda, normalment fis-sieq), kif ukoll anġina instabbli (tip ta' uġigħ sever fis-sider ikkawżat minn problemi fil-fluss tad-demm lejn il-qalb) u ċerti tipi ta' infart kardijaku (attakk tal-qalb);
English: The CHMP agreed that Lovenox can be used for the following uses:
Maltese: Is-CHMP qabel li Lovenox jista' jintuża għall-użu li ġej:
English: The European Commission issued a decision on this opinion on 9/03/2017.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fid-09/03/2017.
English: For the treatment of deep vein thrombosis and pulmonary embolism, the CHMP also clarified that the dose regimen of 150 IU/kg (1.5 mg/kg) given once daily should only be used only in uncomplicated patients who have a low risk of a further venous thromboembolism.
Maltese: Għall-kura ta' trombożi profonda fil-vini u ta' emboliżmu pulmonari, is-CHMP ikkjarifika wkoll li l-kors tad-doża ta' 150 Iu/kg (1.5 mg/kg) li jingħata darba kuljum għandu jintuża biss f'pazjenti mhux ikkumplikati li għandhom riskju baxx ta' tromboemboliżu ġol-vini ulterjuri.
English: The CHMP agreed that the strength of the active substance enoxaparin will now be expressed both in international units (IU) and in milligram (mg) throughout the product information.
Maltese: Is-CHMP qabel li l-qawwa tas-sustanza attiva enoxaparin issa se tiġi espressa kemm f'unitajiet internazzjonali (IU, international units) kif ukoll f'milligrammi (mg) fl-informazzjoni dwar il-prodott kollha.
English: • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg) or pulmonary embolism (clot in a blood vessel supplying the lung);
Maltese: • biex jikkura kondizzjonijiet assoċjati ma' emboli tad-demm bħal trombożi profonda fil-vini (fejn l-embolu jifforma f'vina profonda, normalment fis-sieq) jew emboliżmu pulmonari (emboli f'vażu tad-demm li jforni lill-pulmun);
English: Questions and answers on Lovenox and associated names (enoxaparin, solution for injection)
Maltese: Mistoqsijiet u tweġibiet dwar Lovenox u ismijiet assoċjati (enoxaparin, soluzzjoni għall-injezzjoni)
English: The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding.
Maltese: L-iskeda għandha tintgħażel mit-tabib abbażi ta' valutazzjoni individwali inkluż evalwazzjoni tar-riskju tromboemboliku u r-riskju ta' emorraġija.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Lovenox in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Lovenox fl-Unjoni Ewropea (UE).
English: Lovenox was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Lovenox ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċedura tar-Rikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
Maltese: • biex jikkura anġina instabbli (tip ta' uġigħ sever fis-sider ikkawżat minn problemi fil-fluss tad demm lejn il-qalb);
English: Why was Lovenox reviewed?
Maltese: Għaliex ġie rieżaminat Lovenox?
English: Lovenox is available in all EU countries.
Maltese: Lovenox huwa disponibbli fil-pajjiżi kollha tal-UE.
English: 4.2 Posology and method of administration
Maltese: .2. Pożoloġija u metodu ta' kif għandu jingħata
English: • to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they have reduced mobility due to illness;
Maltese: • biex jipprevjeni tromboemboliżmu ġol-vini (emboli tad-demm li jiffurmaw ġol-vini, li jfixklu l fluss tad-demm), speċjalment f'pazjenti li jkunu qed jiġu operati jew li jinsabu f'riskju akbar ta'
English: A table with dosing recommendations in this group was included.
Maltese: Ġiet inkluża tabella birrakkomandazzjonijiet tad-dożaġġ f'dan il-grupp.
English: Lovenox is authorised in the EU via national procedures.
Maltese: Lovenox huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The lysine analogues epsilon aminocaproic acid (EACA, also referred as aminocaproic acid) and tranexamic acid (TXA) inhibit more specifically the conversion of plasminogen to plasmin.
Maltese: L-analogu ta' lysines epsilon aminocaproic acid (EACA, imsejjaħ ukoll aminocaproic acid) u tranexamic acid (TXA) jinibixxi b'mod iktar speċifiku l-konverżjoni ta' plasminogen fi plasmin.
English: Sufficient evidence of efficacy in this patient population is available.
Maltese: Evidenza suffiċjenti tal-effikaċja f'din il-popolazzjoni ta' pazjenti hija disponibbli.
English: Several data sources informed the opinion of the Committee, including available data from clinical studies, published literature, spontaneous reports and other data submitted by marketing authorisation holders (MAHs) of medicinal products containing aprotinin, EACA or TXA.
Maltese: L-opinjoni tal-Kumitat ġiet iffurmata permezz ta' diversi sorsi ta' dejta, inkluż dejta disponibbli minn studji kliniċi, dokumentazzjoni ppubblikata, rapporti spontanji u dejta oħra sottomessa mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ta' prodotti mediċinali li fihom aprotinin, EACA jew TXA.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Aprotinin containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' riferiment dwar prodotti mediċinali antifibrinolitiċi li fihom Aprotinin (ara Anness I)
English: In March 2010 Germany triggered an article 31 referral to assess the benefits and risks of the antifibrinolytic drugs aprotinin, EACA and TXA in all their approved indications.
Maltese: F'Marzu 2010, il-Ġermanja tat bidu għal riferiment skont l-Artikolu 31 sabiex jiġu evalwati l-benefiċċji u r-riskji tal-mediċini antifibrinolitiċi aprotinin, EACA u TXA fl-indikazzjonijiet approvati kollha tagħhom.
English: Divergent positions are appended to the Opinion.
Maltese: II għall-opinjoni.
English: • The CHMP concluded that the BART data and the signal on increased mortality associated with aprotinin compared to EACA and TXA were not considered reliable, based on the totality of evidence now available since the review of aprotinin undertaken in 2007, including more recent observational studies, the new analyses of the BART study data and the identified major study flaws, and taking the advice of the SAG into account.
Maltese: • Is-CHMP ikkonkluda li d-dejta BART u s-sinjal dwar iż-żieda fil-mortalità assoċjata ma' aprotinin meta mqabbla ma' EACA u TXA ma kinux ikkunsidrati affidabbli, abbażi tat-totalità ta' evidenza issa disponibbli mir-reviżjoni ta' aprotinin li saret fl-2007, inklużi studji aktar reċenti ta' osservazzjoni, l-analiżi l-ġdida tad-dejta tal-istudju BART u d-difetti maġġuri identifikati tal-istudju, u b'kunsiderazzjoni tal-parir tas-SAG.
English: Anaphylactic reactions are another well-known adverse effect that primarily occurs after repeated treatment.
Maltese: Ir-reazzjonijiet anafilattiċi huma effetti avversi oħra magħrufa sew li primarjament iseħħu wara kura ripetuta.
English: The preliminary results of a randomised controlled clinical trial, the ‘Blood conservation using antifibrinolytics: a randomised trial in a cardiac surgery population' (BART) study, had shown that although the use of aprotinin was associated with less serious bleeding than either of the comparator drugs, an increase in 30 day all-cause mortality had been observed among patients receiving aprotinin compared to patients taking other medicines.
Maltese: Ir-riżultati preliminari ta' prova klinika kkontrollata randomizzata, l-istudju dwar il-‘Konservazzjoni tad-demm permezz tal-antifibrinolitiċi: prova randomizzata f'popolazzjoni ta' kirurġija tal-qalb' (BART), urew li minkejja li l-użu ta' aprotinin kien assoċjat ma' fsadiet inqas serji minn dawk li jirriżultaw mill-mediċini ta' tqabbil, ġiet osservata żieda fir-rata ta' mortalità fuq perjodu ta' 30 jum minħabba kwalunkwe kawża fost il-pazjenti li kienu qegħdin jirċievu aprotinin meta mqabbla ma' pazjenti li kienu qegħdin jieħdu mediċini oħra.
English: The reduction of the need for resurgery after coronary artery bypass grafting (CABG) demonstrated for aprotinin is considered to be a benefit of high clinical relevance.
Maltese: It-tnaqqis tal-ħtieġa ta' kirurġija mill-ġdid wara bypass graft tal-arterja koronarja (CABG) muri għal aprotinin huwa kkunsidrat bħala benefiċċju ta' rilevanza klinika għolja.
English: This document presents the conclusions on aprotinin.
Maltese: Dan id-dokument jippreżenta l-konklużjonijiet dwar aprotinin.