FrancophonIA/ELRC3.0 huggingface dataset:
English: abdominal pain, malaise, back pain and increased inflammatory markers.
Maltese: Is-sintomi jistgħu jinkludu deni, uġigħ fl-addome, telqa, uġigħ fid-dahar u żieda fil-markaturi infjammatorji.
English: Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients.
Maltese: L-aortite ġiet irrappurtata wara l-għoti ta' G-CSF f'individwi b'saħħithom u f'pazjenti bil-kanċer.
English: The active substance is tenecteplase.
Maltese: Is-sustanza attiva hi tenecteplase.
English: Primary PCI (n=948)
Maltese: PCI primarju (n=948)
English: Linearity/Non-Linearity
Maltese: Linearità/nuqqas ta' linearità
English: Investigations Rare
Maltese: Investigazzjonijiet Rari
English: GPIIb/IIIa antagonists
Maltese: Antagonisti GPIIb/IIIa
English: STREAM study
Maltese: Studju STREAM
English: Heart arrest
Maltese: Arrest kardijaku
English: D-55216 Ingelheim am Rhein Germany
Maltese: D-55216 Ingelheim am Rhein
English:  60 to < 70  70 to < 80  80 to < 90
Maltese:  60 sa < 70  70 sa < 80  80 sa < 90
English: Tel: +49 (0) 800 77 90 900
Maltese: KG Tel: +49 (0) 800 77 90 900
English: The terminal half-life is 129 ± 87 min, and plasma clearance is 119 ± 49 ml/min.
Maltese: Il-half-life terminali hi ta' 129 ± 87 min, u ttneħħija tal-plażma hi ta' 119 ± 49 ml/min.
English: Chest pain (angina pectoris)
Maltese: Uġigħ fis-sider (angina pectoris)
English: For a full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: The other ingredients are L-arginine, phosphoric acid and polysorbate 20.
Maltese: L-Arginine, Phosphoric Acid, Polysorbate 20
English: Table 1 displays the frequency of adverse reactions.
Maltese: Tabella 1 turi l-frekwenzi ta' reazzjonijiet avversi
English: Pharmaco-invasive (n=944)
Maltese: Farmakoinvażivi (n=944)
English: NAME OF THE MEDICINAL PRODUCT Metalyse 8,000 U
Maltese: TAL-PRODOTT MEDIĊINALI Metalyse 8,000 U
English: This translates into a significantly lower need of transfusions (4.3% vs. 5.5%, p=0.0002).
Maltese: Dan jiġi tradott fi ħtieġa sinifikament iktar baxxa ta' trasfużjonijiet (4.3% vs. 5.5%, p=0.0002).
English: Retroperitoneal haemorrhage (such as retroperitoneal haematoma)
Maltese: Emorraġija retroperitoneali (bħal ematoma retroperitoneali)
English: Prolonged cardiopulmonary resuscitation (> 2 minutes) within the past 2 weeks Acute pericarditis and/or subacute bacterial endocarditis Acute pancreatitis
Maltese: Risuxitazzjoni kardjopulmonari mtawla (> 2 minuti) fl-aħħar ġimagħtejn Perikardite akuta u/jew endokardite batterjali sotto-akuta Pankreatite akuta
English: Intracranial haemorrhage occurred at a rate of 0.93% vs. 0.94% for tenecteplase and alteplase, respectively.
Maltese: Emorraġija intrakranjali seħħet f'rata ta' 0.93% vs. 0.94% għal tenecteplase u alteplase, rispettivament.
English: The initial, dominant half-life is 24 ± 5.5 (mean ±SD) min, which is 5 times longer than native t-PA.
Maltese: Il-half-life inizjali u dominanti hi ta' 24 ± 5.5 (medja ± SD) min, li hi 5 darbiet itwal minn t-PA nattiv.
English: Metalyse is incompatible with glucose solution.
Maltese: Metalyse mhux kompatibbli ma' soluzzjoni ta' glucose.
English: The distribution phase represents 31% ± 22% to 69% ± 15% (mean ± SD) of the total AUC following the administration of doses ranges from 5 to 50 mg.
Maltese: Il-fażi tad-distribuzzjoni tirrappreżenta 31% ± 22% sa 69% ± 15% (medja ± SD) tat-total tal-AUC wara l-għoti ta' meded ta' dożi li jvarjaw minn 5 sa 50 mg.
English: In comparative studies a less than 15% reduction in fibrinogen and a less than 25% reduction in plasminogen were observed in subjects treated with the maximum dose of tenecteplase (10,000 U, corresponding to 50 mg), whereas alteplase caused an approximately 50% decrease in fibrinogen and plasminogen levels.
Maltese: Fi studji komparattivi, kien osservat li kien hemm inqas minn tnaqqis ta' 15% fil-fibrinogen u inqas minn tnaqqis ta' 25% fil-plasminogen f'pazjenti kkurati bid-doża massima ta' tenecteplase (10,000 U, li tikkorrispondi għal 50 mg), filwaqt li alteplase kkawża tnaqqis ta' madwar 50% fil-livelli ta' fibrinogen u plasminogen.
English: Sterile vial adapter.
Maltese: Adapter sterili tal-kunjett.
English: Systolic blood pressure > 160 mm Hg
Maltese: Pressjoni tad-demm sistolika ta' > 160 mm Hg Mard ċerebrovaskulari
English: For coronary intervention see section 4.4.
Maltese: Għal intervent koronarju ara sezzjoni 4.4.
English: cardiac tamponade, myocardial rupture - rare: pulmonary embolism
Maltese: trombożi venuża, għafis kardijaku, ftuq mijokardjali - rari: emboliżmu pulmonari
English: Each vial 40 mg tenecteplase.
Maltese: Kull kunjett fih 40 mg tenecteplase.
English: Each vial 50 mg tenecteplase.
Maltese: Kull kunjett fih 50 mg tenecteplase.
English: Embolism (thrombotic embolisation) Respiratory, thoracic and mediastinal disorders Common
Maltese: Emboliżmu (embolizzazzjoni trombotiċi) Disturbi respiratorji, toraċiċi u medjastinali Komuni
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 65, 88397 Biberach/Riss Germany
Maltese: KG Birkendorfer Strasse 65, 88397 Biberach/Riss Ġermanja
English: No clinically relevant antibody formation was detected at 30 days.
Maltese: L-ebda formazzjoni klinikament rilevanti ta' antikorpi ma kienet osservata wara 30 jum.
English: This observation is consistent with the intended effect of plasminogen activation.
Maltese: Din l-osservazzjoni hi konsistenti ma' l-effett intenzjonat ta' l-attivazzjoni ta' plasminogen.
English: Do not store above 30°C.
Maltese: Taħżinx f'temperatura 'lfuq minn 30°C.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and 8 hours at 30°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 24 siegħa f'temperaturi ta' 2-8°C u 8 sigħat f'temperaturi ta' 30°C.
English: Tenecteplase is not considered to be teratogenic (please see section 5.3).
Maltese: Tenecteplase mhuwiex ikkunsidrat li hu teratoġeniku (ara sezzjoni 5.3).
English: Corresponding volume of reconstituted solution (ml)
Maltese: Volum korrispondenti ta' soluzzjoni rikostitwita (ml)
English: Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Adjunctive therapy
Maltese: Terapija addizzjonali
English: Now solution is ready for iv. bolus injection.
Maltese: Issa issoluzzjoni hija lesta biex tingħata bħala injezzjoni bolus iv.
English: Following intravenous bolus administration of 30 mg tenecteplase in patients with acute myocardial infarction, the initially estimated tenecteplase plasma concentration was 6.45 ± 3.60 µg/mL (mean ± SD).
Maltese: Wara l-għoti ta' bolus ġol-vini ta' 30 mg ta' tenecteplase f'pazjenti b'infart mijokardijaku akut, ilkonċentrazzjoni inizjali stmata ta' tenecteplase fil-plażma kienet ta' 6.45 ± 3.60 µg/mL (medja ± SD).
English: Volume of reconstituted solution (ml)
Maltese: Volum ta' soluzzjoni rikostitwita (ml)
English: The primary endpoint, a composite of death or cardiogenic shock or congestive heart failure or re-infarction within 30 days, was observed in 12.4% (116/939) of the pharmaco-invasive arm versus 14.3% (135/943) in the primary PCI arm (relative risk 0.86 (0.68-1.09)).
Maltese: Il-punt aħħari primarju, kompost ta' mewt jew xokk kardjoġeniku jew insuffiċjenza konġestiva tal-qalb jew infart mill-ġdid fi żmien 30 jum, ġie osservat fi 12.4% (116/939) tal-parti farmakoinvażiva tal-istudju kontra 14.3% (135/943) fil-parti tal-istudju dwar PCI primarju (riskju relattiv 0.86 (0.68-1.09)).
English: Pharmacotherapeutic group: Antithrombotic agents, enzymes; ATC code: B01A D11
Maltese: Sustanzi antitrombotiċi, enzimi; Kodiċi ATC:
English: Date of last renewal: 23 February 2006
Maltese: Data tal-aħħar tiġdid: 23 ta' Frar, 2006
English: Frequency groupings are defined according to the following convention: 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), Not known (cannot be estimated from the available data).
Maltese: 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), Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Reperfusion arrhythmias (such as asystole, accelerated idioventricular arrhythmia, arrhythmia, extrasystoles, atrial fibrillation, atrioventricular first degree to atrioventricular block complete, bradycardia, tachycardia, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia) occur in close temporal relationship to treatment with tenecteplase.
Maltese: Arritmiji ta' riperfużjoni (bħal asistoli, arritmija idjoventrikulari aċċelerata, arritmija, ekstrasistoli, fibrillazzjoni atrijali, atrijoventrikulari tal-ewwel grad għal blokk atrijoventrikulari kompluta, bradikardja, takikardja, arritmija ventrikulari, fibrillazzjoni ventrikulari, takikardja ventrikulari) li huma marbuta mill-qrib ma' tenecteplase.
English: After the dose reduction of tenecteplase by half in patients ≥ 75 years there was no further intracranial hemorrhage (0 of 97 patients) (95% CI: 0.0-3.7) versus 8.1% (3 of 37 patients) (95% CI: 1.7-21.9) prior to dose reduction.
Maltese: Wara t-tnaqqis fid-doża ta' tenecteplase bin-nofs f'pazjenti ta' ≥ 75 sena, ma kien hemm l-ebda emorraġija intrakranjali addizzjonali (0 minn 97 pazjent) (95% CI: 0.0-3.7) kontra 8.1% (3 minn 37 pazjent) (95% CI: 1.7-21.9) qabel it-tnaqqis fid-doża.
English: Once Metalysehas been reconstituted it may be stored for 24 hours at 2-8°C and 8 hours at 30°C.
Maltese: Ġaladarba Metalyse jkun rikostitwit, jista' jinħażen għal 24 siegħa f'temperatura ta' 2-8°C u 8 sigħat f'temperatura ta' 30°C.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/169/006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/169/006
English: Anaphylactoid reaction (including rash, urticaria, bronchospasm, laryngeal oedema)
Maltese: Reazzjonijiet anafilattojdi (li jinkludi r-raxx, urtikarja, bronkospazmu, edema larinġeali)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/169/005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/169/005
English: Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
Maltese: Disfunzjoni severa epatika, li tinkludi kollass epatiku, ċirrożi, pressjoni tad-demm għolja portali (variċi esofagali) u epatite attiva
English: A pre-existing intravenous line may be used for administration of Metalyse in sodium chloride 9 mg/ml (0.9%) solution only.
Maltese: Linja ġol-vina li kienet teżisti minn qabel tista' tintuża għall-għoti ta' Metalyse f'soluzzjoni tassodium chloride 9 mg/ml (0.9%) biss.
English: The pharmaco-invasive strategy consisted of early fibrinolytic treatment with bolus tenecteplase and additional antiplatelet and anticoagulant therapy followed by angiography within 6-24 hours or rescue coronary intervention.
Maltese: L-istrateġija farmakoinvażiva kienet tikkonsisti minn kura fibrinolitika bikrija b'bolus tenecteplase u terapija addizzjonali kontra l-plejtlits u antikoagulanti segwita minn anġjografija fi żmien 6-24 siegħa jew intervent koronarju ta' salvataġġ.
English: Unfractionated heparin and enoxaparin have been used as antithrombotic adjunctive therapy in clinical studies with Metalyse.
Maltese: Eparina mhux frazzjonata u enoxaparin kienu użati bħala terapija addizzjonali antitrombotika fi studji kliniċi b'Metalyse.
English: Uncommon (may affect up to 1 in 100 people):
Maltese: Mhux komuni(jistgħu jaffettwaw sa 1 minn kull 100 persuna):
English: The secondary endpoints re-infarction and repeat target vessel revascularisation were significantly increased in the group pre-treated with tenecteplase: reinfarction: 6.1% vs. 3.7% p=0.0279; repeat target vessel revascularisation: 6.6% vs. 3.4% p=0.0041.
Maltese: Ir-riżultati sekondarji aħħarin ta' l-infart mill-ġdid u tar-rivaskularizzazzjoni ripetuta tal-vina/arterja fil-mira, kienu ogħla sinifikament fil-grupp li kien ikkurat minn qabel b'tenecteplase: infart mill-ġdid: 6.1% vs. 3.7% p=0.0279; rivaskularizzazzjoni ripetuta tal-vina/arterja fil-mira: 6.6% vs. 3.4% p=0.0041.
English: Gastrointestinal haemorrhage (such as gastric haemorrhage, gastric ulcer haemorrhage, rectal haemorrhage, haematemesis, melaena, mouth haemorrhage)
Maltese: Emorraġija gastrointestinali (bħal emorraġija gastrika, emorraġija ta' ulċera gastrika, emorraġija fir-rektum, ematemesi, melaena, emorraġija fil-ħalq)
English: The following adverse events occurred more frequently with tenecteplase prior to PCI: intracranial haemorrhage: 1% vs. 0% p=0.0037; stroke: 1.8% vs. 0% p<0.0001; major bleeds: 5.6% vs. 4.4% p=0.3118; minor bleeds: 25.3% vs. 19.0% p= 0.0021; blood transfusions: 6.2% vs. 4.2% p=0.0873; abrupt vessel closure: 1.9% vs. 0.1% p=0.0001.
Maltese: L-avvenimenti avversi li ġejjin seħħew b'mod iktar frekwenti b'tenecteplase qabel il-PCI: emorraġija intrakranjali: 1% vs. 0% p=0.0037; puplesija: 1.8% vs. 0% p<0.0001; ħruġ ta' demm maġġuri: 5.6% vs. 4.4% p=0.
English: less than 6060 to 7070 to 8080 to90above 90
Maltese: 60 sa 70 70 sa 80 80 sa 90 iktar minn
English: Other medicinesand Metalyse
Maltese: X'fih Metalyse
English: The mean residence time (MRT) in the body is approximately 1 h and the mean (± SD) volume of distribution at the steady-state (Vss) ranged from 6.3 ± 2 L to 15 ± 7 L.
Maltese: Il-medja tal-ħin ta' residenza (MRT) fil-ġisem hi ta' madwar siegħa u l-medja (± SD) tal-volum tad-distribuzzjoni flistat fiss (Vss) varjat minn 6.3 ± 2 L sa 15 ± 7 L.
English: The study population consisted of 1,892 patients randomised by means of an interactive voice response system.
Maltese: Il-popolazzjoni tal-istudju kienet tikkonsisti minn 1,892 pazjent li ntgħażlu b'mod każwali permezz ta' sistema interattiva ta' rispons bil-vuċi.
English: The reconstituted solution contains 1,000 units (5 mg) tenecteplase per ml.
Maltese: Is-soluzzjoni rikostitwita fiha 1,000 unità (5 mg) ta' tenecteplase f'kull 1 ml.
English: Metalyse 10,000 units powder and solvent for solution for injection Tenecteplase
Maltese: Metalyse 10,000 unità trab u solvent għal soluzzjoni għall-injezzjoni
English: PHARMACEUTICAL PARTICULARS
Maltese: Farmakoinvażivi
English: When reconstituted with 8 ml solvent each ml contains 1,000 U tenecteplase.
Maltese: Meta rikostitwita ma' 8 ml ta' solvent kull ml fih 1,000 U tenecteplase.
English: Remove tip-cap from syringe.
Maltese: Neħħi l-għatu tat-tarf mis-siringa.
English: Rare (may affect up to 1 in 1,000 people): Blood clot in the lung (pulmonary embolism)
Maltese: Rari(jistgħu jaffettwaw sa 1 minn kull 1,000 persuna): Embolu tad-demm fil-pulmun (emboliżmu pulmonari)
English: Total stroke (all types)
Maltese: Puplesiji totali (it-tipi kollha)
English: Adverse reactions listed below are classified according to frequency and system organ class.
Maltese: Reazzjonijiet avversi elenkati hawn isfel huma kklassifikati skont il-frekwenza u s-sistema talklassifika tal-organi.
English: 10 ml plastic pre-filled syringe with 8 ml of solvent.
Maltese: Siringa tal-plastik ta' 10 ml mimlija għal-lest b'8 ml ta' solvent.
English: As with other thrombolytic agents, the following events have been reported as sequelae of myocardial infarction and/or thrombolytic administration: very common: hypotension, heart rate and rhythm disorders, angina pectoris common: recurrent ischaemia, cardiac failure, myocardial infarction, cardiogenic shock, pericarditis, pulmonary oedema uncommon: cardiac arrest, mitral valve incompetence, pericardial effusion, venous thrombosis, cardiac tamponade, myocardial rupture rare: pulmonary embolism
Maltese: Bħal sustanzi trombolitiċi oħrajn, l-avvenimenti li ġejjin kienu rrappurtati bħala konsegwenza ta' infart mijokardjali u/jew ta' għoti trombolitiku. komuni ħafna: pressjoni tad-demm baxxa ħafna, disturbi fir-rata u fir-rittmu tal-qalb, anġina pectoris komuni: iskemija rikorrenti, kollass kardijaku, infart mijokardjali, xokk kardjoġeniku, perikardite, edema pulmonari mhux komuni: waqfien tal-qalb, inkompetenza tal-valv mitrali, tnixxija mill-perikardju, trombożi venuża, għafis kardijaku, ftuq mijokardjali rari: emboliżmu pulmonari
English: Coronary intervention
Maltese: Intervent koronarju
English: Low body weight < 60 kg
Maltese: Piż tal-ġisem baxx < 60 kg
English: All-cause mortality Cardiogenic shock Congestive heart failure Re-infarction Cardiac mortality
Maltese: Mortalità mill-kawżi kollha Xokk kardjoġeniku Insuffiċjenza konġestiva tal-qalb Infart mill-ġdid
English: NAME OF THE MEDICINAL PRODUCT Metalyse 10,000 U
Maltese: Metalyse 10,000
English: Intracranial haemorrhage (such as cerebral haemorrhage, cerebral haematoma, haemorrhagic stroke, haemorrhagic transformation stroke, intracranial haematoma, subarachnoid haemorrhage) including associated symptoms as somnolence, aphasia, hemiparesis, convulsion
Maltese: Emorraġija intrakranjali (bħal emorraġija ċerebrali, ematoma ċerebrali, puplesija emorraġika, trasformazzjoni emorraġika pupletika, ematoma intrakranjali, emorraġija sottoaraknojdi) li jinkludu sintomi assoċjati bħal ħedla, afasja, emiparesi, konvulżjoni
English: Numerically all of the components of the clinical composite endpoint were in favour of the PCI only regimen: death: 6.7% vs. 4.9% p=0.14; cardiogenic shock: 6.3% vs. 4.8% p=0.19; congestive heart failure: 12.0% vs. 9.2% p=0.06 respectively.
Maltese: Numerikament, il-komponenti kollha tar-riżultat aħħari tal-kompost kliniku kienu favur il-kors tal-PCI biss: mewt: 6.7% vs. 4.9% p=0.14; xokk kardjoġeniku: 6.3% vs. 4.8% p=0.19; kollass tal-qalb konġestiv:
English: In any case, tenecteplase should not be readministered before assessment of haemostatic factors like fibrinogen, plasminogen and alpha2antiplasmin.
Maltese: Fi kwalunkwe każ, tenecteplase m'għandux jingħata mill-ġdid qabel evalwazzjoni ta' fatturi emostatiċi bħal fibrinogen, plasminogen u alpha2-antiplasmin.
English: NAME OF THE MEDICINAL PRODUCT Metalyse 8,000 units powder and solvent for solution for injection
Maltese: IL-PRODOTT MEDIĊINALI Metalyse 8,000 unità trab u solvent għal soluzzjoni għall-injezzjoni
English: The dose linearity analysis based on AUC suggested that tenecteplase exhibits non-linear pharmacokinetics in the dose range studied, i.e. 5 to 50 mg.
Maltese: L-analiżi tal-linearità tad-doża bbażata fuq l-AUC tissuġġerixxi li tenecteplase juri farmakokinetika mhux lineari fil-medda tad-doża studjat, i.e. 5 sa 50 mg.
English: Rare(may affect up to 1 in 1,000 people): low blood pressure (hypotension) bleeding in the lungs (pulmonary haemorrhage) hypersensitivity (anaphylactoid reactions) e.g.rash, hives (urticaria), difficulty breathing (bronchospasm) bleeding into the area surrounding the heart (haemopericardium) blood clot in the lung (pulmonary embolism) and in the vessels of other organ systems (thrombotic embolisation)
Maltese: Rari(jistgħu jaffettwaw sa 1 minn kull 1,000 persuna): pressjoni tad-demm baxxa (ipotensjoni) emorraġija fil-pulmun (emorraġija pulmonari) sensittività eċċessiva (reazzjonijiet anafilattojdi) eż. raxx, ħorriqija (urtikarja), diffikultà biex tieħu n-nifs (bronkospażmu) ħruġ ta'demm għal ġoż-żona ta'madwar il-qalb (emoperikardju) embolu tad-demm fil-pulmun (emboliżmu pulmonari)u fil-vażi ta' sistemi organiċi oħra (embolizzazzjoni trombotika)
English: The occurrence of the primary endpoint, a composite of death or cardiogenic shock or congestive heart failure within 90 days, was significantly higher in the group receiving the exploratory regimen of tenecteplase followed by routine immediate PCI: 18.6% (151/810) compared to 13.4% (110/819) in the PCI only group, p=0.0045.
Maltese: L-okkorrenza tar-riżultat aħħari primarju, kompost ta' mewt jew xokk kardjoġeniku jew kollass konġestiv tal-qalb fi żmien 90 jum, kien ogħla sinifikament fil-grupp li kien qed jirċievi l-kors esploratorju ta' tenecteplase, segwit minn PCI immedjat ta' rutina: 18.6% (151/810) meta mqabbla ma' 13.4% (110/819) fil-grupp tal-PCI biss, p=0.0045.
English: 10 ml plastic pre-filled syringe with 10 ml of solvent.
Maltese: Siringa tal-plastik ta' 10 ml mimlija għal-lest ma' 10 ml ta' solvent.
English: Nervous system disorders Uncommon
Maltese: Disturbi fis-sistema nervuża
English: Children and adolescents The use of Metalyse in children and adolescents up to the age of18 years is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Metalyse fit-tfal u adolexxenti sal-età ta' 18-il sena mhuwiex rakkomandat.
English: Pericardial haemorrhage
Maltese: Reazzjoni avversa
English: Each vial contains 8,000 units (40 mg) tenecteplase.
Maltese: Kull kunjett 1 fih 8,000 unità (40 mg) tenecteplase.
English: A large scale mortality trial (ASSENT-2) in approx. 17,000 patients showed that tenecteplase is therapeutically equivalent to alteplase in reducing mortality (6.2% for both treatments, at 30 days, upper limit of the 95% CI for the relative risk ratio 1.124) and that the use of tenecteplase is associated with a significantly lower incidence of non-intracranial bleedings (26.4% vs. 28.9%, p=0.0003).
Maltese: Prova kbira dwar il-mortalità (ASSENT-2) f'madwar 17,000 pazjent uriet li tenecteplase hu terapewtikament ekwivalenti għal alteplase fit-tnaqqis tal-mortalità (6.2% għaż-żewġ tipi ta' kuri, wara 30 jum, limitu ta' fuq ta' 95% CI għall-proporzjon ta' riskju relattiv 1.124) u li l-użu ta'
English: Ecchymoses are observed commonly but usually do not require any specific action.
Maltese: L-ekkimosi huma osservati b'mod komuni iżda normalment ma jeħtieġu l-ebda azzjoni speċifika.
English: Clinical data as well as nonclinical studies on fertility are not available for tenecteplase (Metalyse).
Maltese: Dejta klinika kif ukoll studji mhux kliniċi fuq il-fertilità mhumiex disponibbli għal tenecteplase (Metalyse).
English: if you have had any allergic reaction other than a sudden life-threatening allergic reaction (severe hypersensitive) to the active substance tenecteplase, to gentamicin (a trace residue from the manufacturing process), or to any ofthe other ingredients of Metalyse (see section 6: “Contents of the pack and other information”); if you have high blood pressure; if you have problems with circulation of blood in the brain (cerebrovascular disease); if you have had gastrointestinal (gut) or genitourinary bleeding within the last ten days (this may cause blood in stools or urine); if you have a heart valve abnormality (e.g. mitral stenosis) with an abnormal heart rhythm (e.g. atrial fibrillation); if you have had an intramuscular injectionin the last two days; if you are aged over 75 years; if you weigh less than 60 kg; if you have ever received Metalyse before.
Maltese: jekk inti kellek xi reazzjoni allerġika li ma kinetx reazzjoni allerġika f'daqqa u ta' periklu għall-ħajja (sensittività eċċessiva severa) għas-sustanza attiva tenecteplase, għal gentamicin (fdalf'ammonti traċċa mill-proċess ta' produzzjoni) jew għal xi sustanzaoħra ta' Metalyse (ara sezzjoni 6: “Kontenut tal-pakkett u informazzjoni oħra”); jekk għandek pressjoni tad-demm għolja; jekk għandek problemi biċ-ċirkolazzjoni tad-demm fil-moħħ (mard ċerebrovaskulari); jekk kellek ħruġ ta'demm gastrointestinali (fl-imsaren) jew ġenitourinarju matul l-aħħar għaxart ijiem (dan jista'jikkawża demm fl-ippurgar jew fl-awrina); jekk għandek anormalità fil-valv tal-qalb (eż. stenosi mitrali) b'rittmu anormali tal-qalb (eż. fibrillazzjoni atrijali); jekk kellek injezzjoni ġol-muskoli fl-aħħar jumejn; jekk għandek iktar minn 75 sena; jekk tiżen inqas minn 60kg; jekk qatt ma rċivejt Metalyse fil-passat.
English: Potency of tenecteplase is expressed in units (U) by using a reference standard which is specific for tenecteplase and is not comparable with units used for other thrombolytic agents.
Maltese: Il-potenza ta' tenecteplase hi espressa f'unitajiet (U) billi tintuża referenza standard li hi speċifika għal tenecteplase u mhix komparabbli ma' unitajiet użati għall-sustanzi trombolitiċi oħrajn.