FrancophonIA/ELRC3.0 huggingface dataset:
English: What Metalyse is and what it is used for What you need to know before you receive Metalyse How is Metalyse administered Possible side effects
Slovenian: Kaj je zdravilo Metalyse in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Metalyse Kako boste prejeli zdravilo Metalyse Možni neželeni učinki
English: Metalyse is not recommended for use in children (below 18 years) due to a lack of data on safety and efficacy.
Slovenian: Uporabe zdravila Metalyse pri otrocih (mlajših od 18 let) ne priporočamo, ker je na voljo premalo podatkov o varnosti in učinkovitosti.
English: Invert vial/syringe and transfer the appropriate volume of the solution into syringe according to the dosing instructions.
Slovenian: Obrnemo vialo/brizgo in prenesemo ustrezen volumen raztopine v brizgo v skladu z navodili za odmerjanje.
English: Metalyse should be administered with caution in the elderly ( 75 years) due to a higher bleeding risk (see information on bleeding in section 4.4 and on the STREAM study in section 5.1).
Slovenian: Starejšim (> 75 let) je treba zdravilo Metalyse zaradi večjega tveganja za pojav krvavitve dajati previdno (glejte podatke o krvavitvah v poglavju 4.4 in o študiji STREAM v poglavju 5.1).
English: PARTICULARS TO APPEAR ON THE INNER SIDE OF THE LID OF THE CARTON IN FORM OF A PICTOGRAMM
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA NOTRANJI STRANI ROBNEGA DELA ŠKATLE V OBLIKI PIKTOGRAMA
English: However, the effect of renal and hepatic dysfunction on pharmacokinetics of tenecteplase in humans has not been specifically investigated.
Slovenian: Toda specifičnega vpliva ledvične in jetrne disfunkcije na farmakokinetiko tenekteplaze pri ljudeh niso raziskali.
English: Data on tissue distribution were obtained in studies with radioactively labelled tenecteplase in rats.
Slovenian: Podatki o tkivni porazdelitvi izvirajo iz raziskav z radioaktivno označeno tenekteplazo pri podganah.
English: Cerebrovascular disease
Slovenian: • cerebrovaskularna bolezen,
English: In any case, tenecteplase should not be readministered before assessment of haemostatic factors like fibrinogen, plasminogen and alpha2antiplasmin.
Slovenian: Tenekteplaze ne smemo ponovno dajati, ne da bi prej določili hemostatske faktorje, kot so fibrinogen, plazminogen in antiplazmin alfa2.
English: Because elimination of tenecteplase is through the liver, it is not expected that renal dysfunction will affect its the pharmacokinetics.
Slovenian: Ker se tenekteplaza izloča skozi jetra, ledvična disfunkcija predvidoma ne vpliva na njeno farmakokinetiko.
English: Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Slovenian: Koronarna tromboliza lahko povzroči aritmijo, ki jo spremlja reperfuzija.
English: However there is no systematic experience with re-administration of tenecteplase.
Slovenian: Vendar s ponovnim dajanjem tenekteplaze ni sistematičnih izkušenj.
English:  60 to < 70  70 to < 80  80 to < 90
Slovenian:  60 do < 70  70 do < 80  80 do < 90
English: Active peptic ulceration
Slovenian: • aktivni peptični ulkus,
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.
Slovenian: Če je perkutana koronarna intervencija (PKI) načrtovana v skladu z veljavnimi smernicami za zdravljenje, tenekteplaze (glejte poglavje 5.1 študija ASSENT-4) ne smete dajati.
English: Any unused solution should be discarded.
Slovenian: Neporabljeno raztopino moramo zavreči.
English: The required dose should be administered as a single intravenous bolus over approximately 10 seconds.
Slovenian: Potreben odmerek vnesemo z enim intravenskim bolusom v približno 10 sekundah.
English: In the following conditions, the risk of tenecteplase therapy may be increased and should be weighed against the anticipated benefits:
Slovenian: Pri naštetih stanjih je lahko tveganost zdravljenja s tenekteplazo povečana, zato moramo o njegovi uvedbi presoditi glede na pričakovano korist:
English: Treatment with Metalyse should be initiated as soon as possible after onset of symptoms.
Slovenian: Zdravljenje z zdravilom Metalyse moramo začeti čimprej po pojavu simptomov.
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.
Slovenian: Analiza linearnosti odmerka, ki je temeljila na AUC, je kazala, da ima tenekteplaza nelinearno farmarmakokinetiko v preskušanem razponu odmerkov, to je 5 do 50 mg.
English: If an anaphylactoid reaction occurs, the injection should be discontinued immediately and appropriate therapy should be initiated.
Slovenian: Če se pojavi anafilaktoidna reakcija, moramo injiciranje takoj prekiniti in uvesti ustrezno zdravljenje.
English: Severe uncontrolled hypertension
Slovenian: • huda nenadzorovana hipertenzija,
English: Unfractionated heparin and enoxaparin have been used as antithrombotic adjunctive therapy in clinical studies with Metalyse.
Slovenian: Nefrakcionirani heparin in enoksaparin so že uporabili kot dodatno protitrombotično zdravilo v kliničnih preskušanjih zdravila Metalyse.
English: Concomitant use of GPIIb/IIIa antagonists increases bleeding risk.
Slovenian: Sočasna uporaba antagonistov GPIIb/IIIa poveča tveganje krvavitve.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and 8 hours at 30°C.
Slovenian: Kemična in fizikalna stabilnost med uporabo je preverjena za čas do 24 ur pri 2-8 °C in do 8 ur pri 30 °C.
English: КГ - клон България
Slovenian: КГклон България
English: ** the incidence in the pharmaco-invasive group is as expected for fibrinolysis with tenecteplase (as observed in previous studies).
Slovenian: ** V skupini s farmakoinvazivno strategiijo je pojavnost takšna, kot je pri fibrinolizi s tenekteplazo pričakovana (po podatkih iz prejšnjih študij).
English: Failure to do so may lead to greater than the required dose of Metalyse being administered.
Slovenian: Zaradi neupoštevanja navodil se lahko zgodi, da boste odmerili večji odmerek Metalysa, kot je potreben.
English: METHOD OF ADMINISTRATION Reconstituted solution, for patients of body weight (kg):
Slovenian: POSTOPEK UPORABE Pripravljena raztopina, za bolnika telesne mase (kg):
English: The doctor calculates your dose of Metalyseaccording to your bodyweight, based on the following scheme:
Slovenian: Zdravnik izračuna za vas ustrezen odmerek zdravila Metalysena podlagi vaše telesne mase po naslednji shemi:
English: Open the top of the vial-adapter.
Slovenian: Odpremo zgornji del nastavka za vialo.
English: For details see section 6.6: Special precautions for disposal and other handling
Slovenian: Glejte poglavje 6.6: Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
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.
Slovenian: Raziskava ASSENT-4 PCI je bila načrtovana tako, da bi pokazala, ali bo izid zdravljenja pri 4000 bolnikih z obsežnim miokardnim infarktom ob predzdravljenju s polnimi odmerki tenekteplaze in sočasni enkratni bolusni injekciji do 4000 i.e. nefrakcioniranega heparina pred primarno PKI, ki bo opravljena v 60 do 180 minutah, boljši kot ob sami primarni PKI.
English: Transfusion of cryoprecipitate, fresh frozen plasma, and platelets should be considered with clinical and laboratory reassessment after each administration.
Slovenian: Presoditi je treba o transfuziji krioprecipitata, sveže zamrznjene plazme in trombocitov in po vsaki transfuziji bolnikovo stanje ponovno oceniti s klinično in laboratorijsko preiskavo.
English: less than 6060 to 7070 to 8080 to 90above 90
Slovenian: manj kot 6060 do 7070 do 8080 do 90več kot 90
English: There is limited amount of data from the use of Metalyse in pregnant women.
Slovenian: Podatkov o uporabi zdravila Metalyse pri nosečnicah je malo.
English: It is not known if tenecteplase is excreted in human milk.
Slovenian: Ni znano ali se tenektoplaza izloča v materino mleko.
English: As fibrin is lysed during tenecteplase therapy, bleeding from recent puncture site may occur.
Slovenian: Ker se med zdravljenjem s tenekteplazo fibrin raztaplja, lahko pride do krvavitve na mestu nedavne punkcije.
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).
Slovenian: Intrakranialna krvavitev po spremembi protokola na polovični odmerek pri bolnikih, starih ≥ 75 let: * Pojavnost v obeh skupinah je bila takšna, kot je pričakovana za bolnike z miokardnim infarktom z dvigom spojnice ST, ki se zdravijo s fibrinolitiki ali primarno PKI (po podatkih iz prejšnjih študij).
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.
Slovenian: V primerjalnih raziskavah se je pri bolnikih, ki so jih zdravili z največjim odmerkom tenekteplaze (10.000 E, kar ustreza 50 mg), raven fibrinogena zmanjšala za manj kot 15 % in plazminogena za manj kot 25 %, alteplaza pa je povzročila približno 50-odstotno zmanjšanje ravni fibrinogena in plazminogena.
English: Metalyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use.
Slovenian: Zdravilo Metalyse morajo predpisati zdravniki, ki imajo izkušnje s trombolitičnim zdravljenjem in na voljo opremo za njegovo spremljanje.
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).
Slovenian: Neklinični podatki o tenekteplazi so pokazali krvavitev in sekundarno umrljivost samic zaradi znanega farmakološkega delovanja zdravilne učinkovine ter v nekaj primerih splav in resorpcijo plodu (te učinke so opazili samo pri ponovljenih odmerkih).
English: These cardiovascular events can be life-threatening and may lead to death.
Slovenian: Našteti srčnožilni dogodki so lahko življenjsko nevarni in lahko povzročijo smrt.
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.
Slovenian: Srednji čas zadrževanja v telesu je približno 1 ura, srednja (± SD) prostornina porazdelitve v stanju dinamičnega ravnovesja (Vss) pa 6,3 ± 2 l do 15 ± 7 l.
English: In both groups the bounds of the confidence interval of the observed incidences prior and post dose reduction are overlapping.
Slovenian: V obeh skupinah se meje intervala zaupanja pri pojavnosti pred zmanjšanjem odmerka in po njem prekrivajo.
English: Tenecteplase (U)
Slovenian: Tenekteplaza (E)
English: Very common (may affect more than 1 in 10 people): bleeding
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): krvavitev.
English: cardiac tamponade, myocardial rupture - rare: pulmonary embolism
Slovenian: tamponada srca, ruptura miokardija, - redki: pljučna embolija.
English: Accordingly, there is no guidance for the adjustment to tenecteplase dose in patients with hepatic and severe renal insufficiency.
Slovenian: Zato o prilagoditvi odmerka tenekteplaze za bolnike z jetrno ali hudo ledvično insuficienco ni priporočil.
English: Children and adolescents The use of Metalyse in children and adolescents up to the age of 18 years is not recommended.
Slovenian: Otroci in mladostniki Uporaba zdravila Metalyse pri otrocih do 18.leta starosti ni priporočena.
English: Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete,ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: The other ingredients are L-arginine, phosphoric acid and polysorbate 20.
Slovenian: Pomožne snovi so L-arginin, fosforjeva kislina in polisorbat 20.
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).
Slovenian: Bolnike, pri katerih primarne perkutane koronarne intervencije ni mogoče opraviti v eni uri, kot priporočajo smernice, in prejemajo tenekteplazo za primarno koronarno rekanalizacijo, je treba brez odlašanja premestiti v enoto, ki je opremljena za izvajanje koronarnih intervencij, opraviti angiografijo in pravočasno izvesti dodatno koronarno intervencijo v 6 do 24 urah ali prej, če je medicinsko indicirano (glejte poglavje 5.1 študija STREAM).
English: The initial, dominant half-life is 24 ± 5.5 (mean ±SD) min, which is 5 times longer than native t-PA.
Slovenian: Začetna, prevladujoča razpolovna doba je 24 ± 5,5 (srednja vrednost ± SD) minut, kar je petkrat dlje kot pri naravnem t-PA.
English: Most frequently haemorrhage at the injection site, and occasionally genitourinary and gingival bleeding were observed.
Slovenian: Najpogosteje so zasledili krvavitev na mestu injekcije, občasno pa urogenitalno krvavitev in krvavitev dlesni.
English: Tel: +49 (0) 800 77 90 900
Slovenian: KG Tel: +49 (0) 800 77 90 900
English: SPECIAL STORAGE CONDITIONS Keep the container in the outer carton.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Vsebnik shranjujte v zunanji ovojnini.
English: Metalyse is to be administered to the patient, intravenously in about 10 seconds.
Slovenian: Zdravilo Metalyse injiciramo bolniku intravensko v 10 sekundah.
English: Safety pharmacology data in cynomolgus monkeys revealed reduction of blood pressure followed by changes of ECG, but these occurred at exposures that were considerably higher than the clinical exposure.
Slovenian: Farmakološki podatki o varnosti pri opicah vrste cynomolgus so pokazali zmanjšanje krvnega tlaka in prehodne motnje na izvidu EKG, ki pa so se pojavili samo ob odmerkih, veliko večjih od klinično uporabljanih.
English: Metalyse belongs to a group of medicines called thrombolytic agents.
Slovenian: Zdravilo Metalyse sodi v skupino zdravil, ki jih imenujemo trombolitiki.
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev,se posvetujte z zdravnikom, preden prejmete zdraviloMetalyse.
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.
Slovenian: Farmakoinvazivna strategija je zajemala zgodnje fibrinolitično zdravljenje s tenekteplazo v bolusu ter dodatno protitrombocitno in antikoagulacijsko zdravljenje, zatem so v 6 do 24 urah izvedli angiografijo ali opravili reševalno koronarno intervencijo.
English: Tenecteplase induced total litter deaths during the mid-embryonal period.
Slovenian: Tenekteplaza je povzročila pogin celotnega zaroda v sredini embrionalnega razvoja.
English: Incidence of total strokes and intracranial haemorrhage
Slovenian: Pojavnost vseh možganskih kapi in intrakranialnih krvavitev
English: Total stroke (all types)
Slovenian: Skupno možganska kap (vse oblike)
English: When tenecteplase was given during the mid- or late-embryonal period maternal animals showed vaginal bleeding on the day after the first dose.
Slovenian: Če so tenekteplazo dajali v srednjem in poznem obdobju embrionalnega razvoja, se je pri samicah dan po prvem odmerku pojavila krvavitev iz nožnice.
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.
Slovenian: Po dajanju tenekteplaze so zasledili od velikosti odmerka odvisno porabo antiplazmina 2 (zaviralca plazmina tekoče faze) s posledičnim povečanjem sistemskega nastajanja plazmina.
English: A pre-existing intravenous line may be used for administration of Metalyse in sodium chloride 9 mg/ml (0.9%) solution only.
Slovenian: Zdravilo Metalyse smemo dajati skozi že vstavljen intravenski kateter samo v 9 mg/ml (0,9 %) raztopini natrijevega klorida.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/169/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/169/005
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).
Slovenian: Po intravenskem bolusu 30 mg tenekteplaze je bila pri bolnikih z akutnim miokardnim infarktom začetna ocena koncentracije tenekteplaze v plazmi 6,45 ± 3,60 µg/ml (srednja vrednost ± SD).
English: Multiple-dose toxicity studies in rats and dogs confirmed these above-mentioned observations, but the study duration was limited to two weeks by antibody formation to the human protein tenecteplase, which resulted in anaphylaxis.
Slovenian: Raziskave o toksičnosti večkratnih odmerkov so pri podganah in psih potrdile opisane učinke, vendar je nastajanje protiteles proti človeškemu proteinu tenekteplazi, ki je povzročilo anafilaksijo, trajanje raziskav omejevalo na 2 tedna.
English: Metalyse is incompatible with glucose solution.
Slovenian: Zdravilo Metalyse je inkompatibilno z raztopino glukoze.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/169/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/00/169/006
English: Tenecteplase is cleared from circulation by binding to specific receptors in the liver followed by catabolism to small peptides.
Slovenian: Iz obtoka se izloča z vezavo na specifične receptorje v jetrih, čemur sledi katabolična razgradnja v majhne peptide.
English: Tenecteplase is a recombinant fibrin-specific plasminogen activator.
Slovenian: Tenekteplaza je rekombinantni fibrinsko specifični aktivator plazminogena.
English: Haemorrhage is a very common undesirable effect associated with the use of tenecteplase.
Slovenian: Krvavitev je pri uporabi tenekteplaze zelo pogost neželeni učinek.
English: What Metalyse looks like and contents of the pack
Slovenian: Izgled zdravila Metalyse in vsebina pakiranja
English: No clinically relevant antibody formation was detected at 30 days.
Slovenian: Po 30 dneh niso zasledili klinično pomembnega nastajanja protiteles.
English: Summary of the safety profile
Slovenian: Povzetek varnostnih značilnosti zdravila
English: In case of bleeding in the brain events related to the nervous system have been reported e.g. drowsiness (somnolence), speech disorders, palsy of parts of the body (hemiparesis) and fits (convulsions).
Slovenian: V primerih, ko je prišlo do krvavitve v možganih, so poročali o posameznih dogodkih, povezanih z živčnim sistemom, kot so dremavost (somnolenca), motnje govora, ohromelost telesnih delov (hemipareza) in krče (konvulzije).
English: Tenecteplase is a fibrin-specific plasminogen activator produced in a Chinese hamster ovary cell line by recombinant DNA technology.
Slovenian: Tenekteplaza je fibrinsko specifični aktivator plazminogena, izdelan na liniji ovarijskih celic kitajskega hrčka s tehnologijo rekombinantne DNA.
English: Pharmaco-invasive (n=944)
Slovenian: Farmakoinvazivna strategija (n = 944)
English: Ensure that the appropriate vial size is chosen according to the body weight of the patient.
Slovenian: Izberemo ustrezno velikost viale glede na bolnikovo telesno maso.
English: The solvent is clear and colourless.
Slovenian: Vehikel je prozoren in brezbarven.
English: Intravenous single dose administration in rats, rabbits and dogs resulted only in dose-dependent and reversible alterations of the coagulation parameters with local haemorrhage at the injection site, which was regarded as a consequence of the pharmacodynamic effect of tenecteplase.
Slovenian: Enkratni intravenski odmerki so pri podganah, kuncih in psih povzročili le od velikosti odmerka odvisne reverzibilne spremembe parametrov strjevanja krvi z lokalnimi krvavitvami na mestu injiciranja, kar so ocenili kot posledico farmakodinamičnega učinka tenekteplaze.
English: Tenecteplase has a higher fibrin specificity and greater resistance to inactivation by its endogenous inhibitor (PAI-1) compared to native t-PA.
Slovenian: Tenekteplaza je s svojim endogenim zaviralcem (PAI-1) bolj specifična za fibrin in odpornejša na inaktivacijo v primerjavi z naravnim t-PA.
English: Retroperitoneal haemorrhage (such as retroperitoneal haematoma)
Slovenian: občasni retroperitonealna krvavitev (na primer retroperitonealni hematom)
English: Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cutdown sites and needle puncture sites).
Slovenian: Zato moramo med trombolitičnim zdravljenjem pozorno nadzorovati vsa mesta, kjer bi lahko prišlo do krvavitve (tudi mesto vstavitve katetra, arterijske in venske punkcije, kirurškega vreza in vboda igle).
English: Coronary patency and limited clinical outcome data showed that AMI patients have been successfully treated later than 6 hours after symptom onset.
Slovenian: Podatki o prehodnosti koronarne arterije in manjše število kliničnih izidov so pokazali, da je bilo zdravljenje uspešno tudi pri bolnikih z akutnim miokardnim infarktom, ki so jih začeli zdraviti pozneje kot 6 ur po pojavu simptomov.
English: Low body weight < 60 kg
Slovenian: • majhna telesna masa (< 60 kg),
English: Patients' body weight category (kg)
Slovenian: Bolnikova telesna masa (kg)
English: In case of severe prolonged bleeding substitution therapy may be considered (plasma, platelets), see also section 4.4.
Slovenian: Kadar je krvavitev huda in traja dlje časa, presodimo o nadomestnem zdravljenju (plazma, trombociti).Glej tudi poglavje 4.4.
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.
Slovenian: če jemljete tablete ali kapsule za "redčenje" krvi, npr. varfarin ali kumarin (antikoagulanse); če imate vnetje trebušne slinavke (pankreatitis); če ste pred nedavnim imeli večjo operacijo, tudi možganov ali hrbtenjače; če so vas v preteklih dveh tednih oživljali z masažo srca in umetnim dihanjem (pritiski na prsni koš) dlje kot 2 minuti.
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.
Slovenian: Zdravilo Metalyse je pri odraslih indiciran za trombolitično zdravljenje pri sumu na miokardni infarkt s persistentno elevacijo spojnice ST ali nedavnim levokračnim blokom, v 6 urah po pojavu simptomov akutnega miokardnega infarkta.
English: Metalyse is used to treat myocardial infarctions (heart attacks) within 6 hours after the onset of symptoms and helps to dissolve the blood clots that have formed in the blood vessels of the heart.
Slovenian: Zdravilo Metalyse uporabljamo v zdravljenju miokardnega infarkta (srčni napad) in ga dajemo v 6 urah po pojavu simptomov, in sicer za raztapljanje krvnih strdkov, ki so nastali v srčnih krvnih žilah.