FrancophonIA/ELRC3.0 huggingface dataset:
English: Reperfusion arrhythmias may lead to cardiac arrest, can be life threatening and may require the use of conventional antiarrhythmic therapies.
Danish: Reperfusionsarytmier kan medføre hjertestop, kan være livstruende og kan nødvendiggøre brug af konventionel antiarytmisk behandling.
English: Pharmaco-invasive (n=944)
Danish: Farmako-invasivt (n=944)
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.
Danish: Flerdosistoksicitetsstudier i rotter og hunde bekræftede disse ovenfor nævnte observationer, men studievarigheden var begrænset til 2 uger af antistofdannelse til det humane protein tenecteplase, hvilket resulterede i anafylaksi.
English: When tenecteplase was given during the mid- or late-embryonal period maternal animals showed vaginal bleeding on the day after the first dose.
Danish: Da tenecteplase blev givet under midt- eller senembryonal perioden fik moderdyrerne vaginal blødning dagen efter den første dosering.
English: Check that the cap of the vial is still intact.
Danish: Undersøg om hætten til hætteglasset stadig er intakt.
English: If an anaphylactoid reaction occurs, the injection should be discontinued immediately and appropriate therapy should be initiated.
Danish: Hvis der opstår en anafylaktoid reaktion skal injektionen afbrydes øjeblikkeligt og hensigtsmæssig behandling skal initieres.
English: Metalyse belongs to a group of medicines called thrombolytic agents.
Danish: Metalyse hører til en gruppe lægemidler, som kaldes trombolytiske stoffer.
English: Because elimination of tenecteplase is through the liver, it is not expected that renal dysfunction will affect its the pharmacokinetics.
Danish: Fordi eliminationen af tenecteplase sker gennem leveren, forventes det ikke, at nedsat nyrefunktion vil påvirke dets farmakokinetik.
English: Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued with lifelong treatment unless it is contraindicated.
Danish: Behandling med acetylsalicylsyre bør initieres hurtigst muligt efter symptomdebut og fortsættes som livslang behandling, medmindre det er kontraindiceret.
English: Arterial aneurysm and known arterial/venous malformation Neoplasm with increased bleeding risk
Danish: Arteriel aneurisme og kendt arteriel/venøs misdannelse Neoplasma med stigende blødningstendens
English: The type of haemorrhage is predominantly superficial at the injection site.
Danish: Disse blødninger er overvejende overfladiske på injektionsstedet.
English: From a microbiological point of view, the reconstituted solution should be used immediately.
Danish: Fra en mikrobiologisk synsvinkel bør den rekonstituerede opløsning straks anvendes.
English: Trace residue from manufacturing process: Gentamicin
Danish: Sporrest fra fremstillingsprocessen: Gentamicin.
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.
Danish: Analyse af dosislinearitet baseret på AUC antyder, at tenecteplase udviser non-lineær farmakokinetik i det undersøgte dosisinterval, dvs. 5 til 50 mg.
English: Failure to do so may lead to greater than the required dose of Metalyse being administered.
Danish: Fejlagtig udførelse kan føre til en større indgivelsesdosis af Metalyse end påkrævet.
English: The use of rigid catheters as well as intramuscular injections and non-essential handling of the patient should be avoided during treatment with tenecteplase.
Danish: Brug af stive katetre, intramuskulære injektioner og unødig flytning af patienten skal undgås under behandling med tenecteplase.
English: Tenecteplase has a higher fibrin specificity and greater resistance to inactivation by its endogenous inhibitor (PAI-1) compared to native t-PA.
Danish: Tenecteplase har en højere fibrinspecificitet og større modstand mod inaktiveringen af dets endogene inhibitor (PAI-I) sammenlignet med t-PA.
English: Gentamicin is contained as trace residue from the manufacturing process
Danish: Gentamicin som en rest i spormængde fra fremstillingsprocessen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/169/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/00/169/005
English: STREAM study
Danish: STREAM-studiet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/169/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/00/169/006
English: Should serious bleeding occur, in particular cerebral haemorrhage, concomitant heparin administration should be terminated immediately.
Danish: Skulle alvorlige blødninger opstå, specielt cerebral hæmoragi, skal ledsagende heparinbehandling termineres med det samme.
English: Coronary patency and limited clinical outcome data showed that AMI patients have been successfully treated later than 6 hours after symptom onset.
Danish: Åbning af koronararterierne og begrænsede kliniske data har vist at AMI-patienter er blevet velbehandlet senere end 6 timer efter symptomdebut.
English: It is recommended that antiarrhythmic therapy for bradycardia and/or ventricular tachyarrhythmias (pacemaker, defibrillator) is available when tenecteplase is administered.
Danish: Det anbefales, at antiarytmisk behandling for bradykardi og/eller ventrikulære takyarytmier (pacemaker, defibrillator) er tilgængelig når tenecteplase administreres.
English: Treatment with Metalyse should be initiated as soon as possible after onset of symptoms.
Danish: Behandling med Metalyse bør initieres hurtigst muligt efter symptomdebut.
English: Metalyse should be administered on the basis of body weight, with a maximum dose of 10,000 units (50 mg tenecteplase).
Danish: Metalyse bør administreres på basis af legemsvægt, med en maksimum dosis på 10.000 enheder (50 mg tenecteplase).
English: Administration of protamine should be considered if heparin has been administered within 4 hours before the onset of bleeding.
Danish: Protaminbehandling bør overvejes hvis heparin er givet mindre end 4 timer før blødningsstarten.
English: Tenecteplase is cleared from circulation by binding to specific receptors in the liver followed by catabolism to small peptides.
Danish: Tenecteplase elimineres fra blodbanen ved binding til specifikke receptorer i leveren efterfulgt af nedbrydning til små peptider.
English: The main organ to which tenecteplase distributed was the liver.
Danish: Det organ som tenecteplase hovedsageligt fordelte sig til var leveren.
English: Alternatively the reconstitution can be performed with the included needle.
Danish: Alternativt kan opløsningen fremstilles med den vedlagte kanyle.
English: Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Danish: Koronartrombolyse kan resultere i arytmier i forbindelse med reperfusion.
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.
Danish: Det binder sig til fibrinkomponenten af tromben (størknet blod) og konverterer selektivt trombebundet plasminogen til plasmin, som nedbryder trombens fibrinmatrix.
English: Patients' body weight category (kg)
Danish: Patientens legemsvægt (kg)
English: The most common complication encountered during tenecteplase therapy is bleeding.
Danish: Den hyppigste komplikation under tenecteplasebehandling er blødning.
English: In case of severe prolonged bleeding substitution therapy may be considered (plasma, platelets), see also section 4.4.
Danish: I tilfælde af alvorlig langvarig blødning kan erstatningsbehandling overvejes (plasma, trombocytter), se også pkt.
English: However, the effect of renal and hepatic dysfunction on pharmacokinetics of tenecteplase in humans has not been specifically investigated.
Danish: Dog er effekten af nedsat nyre- og leverfunktion på tenecteplases farmakokinetik hos mennesker ikke specifikt undersøgt.
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).
Danish: Prækliniske data med tenecteplase viser blødning med sekundær dødelighed hos moderdyrene på grund af det aktive stofs kendte farmakologiske aktivitet, og i få tilfælde forekom der aborter og fosterresorption (virkninger er kun observeret ved administration af gentagne doser).
English: Tenecteplase is not considered to be teratogenic (please see section 5.3).
Danish: Tenecteplase anses ikke for at være teratogent (se pkt.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Please follow accurately the instructions for use.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Følg nøje brugervejledningen.
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).
Danish: Efter intravenøs bolus-administration af 30 mg tenecteplase hos patienter med akut myokardieinfarkt var den oprindeligt vurderede tenecteplase-plasmakoncentration 6,45 ± 3,60 µg/ml (gennemsnit ± SD).
English: No local irritation of the blood vessel was observed after intravenous, intra-arterial or paravenous administration of the final formulation of tenecteplase.
Danish: Ingen lokal irritation af blodkar viste sig efter intravenøs, intraarteriel eller paravenøs administration af den endelige opløsning af tenecteplase.
English: The initial, dominant half-life is 24 ± 5.5 (mean ±SD) min, which is 5 times longer than native t-PA.
Danish: Den initiale, dominerende halveringstid er 24  5,5 (gennemsnitlig ± SD) min., hvilket er 5 gange længere end t-PA.
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.
Danish: Intravenøs enkeltdosisadministration i rotter, kaniner og hunde viste kun dosisafhængige og reversible forandringer af koagulationsparametre med lokal blødning på injektionsstedet, hvilket blev tolket som en konsekvens af den farmakodynamiske effekt af tenecteplase.
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.
Danish: Lægemidler, som påvirker koagulationen eller de som ændrer trombocytfunktionen (f.eks. ticlopidine, clopidogrel, LMWH) kan forøge risikoen for blødning før, under og efter tenecteplasebehandling.
English: PARTICULARS TO APPEAR ON THE INNER SIDE OF THE LID OF THE CARTON IN FORM OF A PICTOGRAMM
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN DETALJER SOM KAN SES PÅ INDERSIDEN AF LÅGET PÅ KARTONEN I FORM AF ET PIKTOGRAM
English: Binding to hepatic receptors is, however, reduced compared to native tPA, resulting in a prolonged half-life.
Danish: Bindingen til leverreceptorer er dog reduceret i forhold til det naturlige t-PA, hvilket resulterer i en længere halveringstid.
English: КГ - клон България
Danish: КГклон България
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.
Danish: Hvis der er planlagt primær perkutan koronar intervention (PCI) i henhold til gældende relevante behandlingsvejledninger, bør tenecteplase ikke gives (se pkt.
English: A pre-existing intravenous line may be used for administration of Metalyse in sodium chloride 9 mg/ml (0.9%) solution only.
Danish: En allerede eksisterende intravenøs indgang med kun natriumkloridopløsning 9 mg/ml (0,9 %) kan bruges til behandling med Metalyse.
English: Very common (may affect more than 1 in 10 people): bleeding
Danish: Meget almindelig (kan forekomme hos flere end 1 ud af 10 patienter): blødning
English: Excipients: L-Arginine, Phosphoric Acid, Polysorbate 20 Trace residue from manufacturing process: Gentamicin The solvent is water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: L-arginin, phosphorsyre, polysorbat 20 Sporrest fra fremstillingsprocessen: Gentamicin Solvens er vand til injektionsvæske.
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.
Danish: Data fra fase I og II angiografiske studier antyder at tenecteplase, adminstreret som en enkelte intravenøs bolus, er effektiv til at opløse blodpropper på en dosisrelateret basis i den infarktrelaterede arterie hos forsøgspersoner som oplever et AMI.
English: Patients receiving oral anticoagulants: The use of Metalyse may be considered when dosing or time since the last intake of anticoagulant treatment makes residual efficacy unlikely and if appropriate test(s) of anticoagulant activity for the product(s) concerned show no clinically relevant activity on the coagulation system (e.g. INR ≤ 1.3 for vitamin K antagonists or other relevant test(s) for other oral anticoagulants are within the respective upper limit of normal).
Danish: Patienter i behandling med orale antikoagulantia: Metalyse kan overvejes, når resterende virkning af antikoagulans er usandsynlig ud fra dosering eller tiden siden sidste administration, og hvis relevant(e) test for antikoagulerende aktivitet af det (de) pågældende præparat(er) ikke viser en klinisk relevant aktivitet på koagulationssystemet (f.eks. INR ≤ 1,3 for vitamin Kantagonister, eller andre relevante test for øvrige orale antikoagulantia er indenfor de respektive øvre normalgrænser).
English: Phosphoric acid
Danish: Phosphorsyre
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.
Danish: STREAM-studiet var designet til at evaluere virkningen og sikkerheden af en farmako-invasiv strategi versus en strategi med standard primær PCI hos patienter med akut myokardieinfarkt med STelevation indenfor 3 timer efter symptomdebut, hvor PCI indenfor en time efter første medicinske kontakt ikke er muligt.
English: The side effects described below have been experienced by people given Metalyse:
Danish: Bivirkningerne nedenfor er set hos patienter, der har været behandlet med Metalyse:
English: There is no dose dependence of tenecteplase clearance in the therapeutic dose range.
Danish: Der er ingen dosisafhængig tenecteplaseclearance i det terapeutiske dosisområde.
English: Tenecteplase is a recombinant fibrin-specific plasminogen activator.
Danish: Tenecteplase er en rekombinant fibrinspecifik plasminogen-aktivator.
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.
Danish: Metalyse bruges til at behandle en blodprop i hjertet (myokardieinfarkt), inden for 6 timer efter de første symptomer viser sig, og hjælper med at opløse blodpropper, som er opstået i hjertets blodkar.
English: Pharmacotherapeutic group: Antithrombotic agents, enzymes; ATC code: B01A D11
Danish: Farmakoterapeutisk klassifikation: Antitrombotisk stof, enzymer, ATC-kode: B 01 AD11
English: Most frequently haemorrhage at the injection site, and occasionally genitourinary and gingival bleeding were observed.
Danish: Hyppigst blev der observeret hæmoragi på injektionsstedet, og lejlighedsvis blødning i køns- og urinveje og i tandkødet.
English: Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
Danish: Enhver anamnese med skader på centralnervesystemet (f.eks. neoplasma, aneurisme, intrakraniel eller spinal operation)
English: The bounds of the confidence interval of the observed incidences prior and after dose reduction are overlapping.
Danish: Der er overlappende grænser for konfidensintervallet for de observerede forekomster før og efter dosisreduktion.
English: In both groups the bounds of the confidence interval of the observed incidences prior and post dose reduction are overlapping.
Danish: I begge grupper er der overlappende grænser for konfidensintervallet for de observerede forekomster før og efter dosisreduktion.
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.
Danish: Den farmako-invasive strategi bestod af tidlig fibrinolytisk behandling med bolus-tenecteplase og yderligere antitrombotisk og antikoagulant behandling, efterfulgt af angiografi indenfor 6-24 timer eller akut koronar intervention.
English: Now solution is ready for iv. bolus injection.
Danish: Nu er opløsningen klar til intravenøs bolusinjektion.
English: Transfer the appropriate volume of reconstituted solution of Metalyse into the syringe, based on the patient's weight.
Danish: Overfør den passende mængde opløsning af Metalyse ind i injektionssprøjten, baseret på patientens vægt.
English: Metalyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use.
Danish: Metalyse skal ordineres af læger med erfaring i trombolytisk behandling og med mulighed for at monitorere denne behandling.
English: The concomitant use of heparin anticoagulation may contribute to bleeding.
Danish: Samtidig behandling med heparin kan bidrage til blødning.
English: After single intravenous bolus injection of tenecteplase in patients with acute myocardial infarction, tenecteplase antigen exhibits biphasic elimination from plasma.
Danish: Efter enkelt intravenøs bolusinjektion af tenecteplase hos patienter med akut myokardieinfarkt udviste tenecteplaseantigen bifasisk elimination fra plasma.
English: Metalyse should be reconstituted by adding the complete volume of water for injections from the prefilled syringe to the vial containing the powder for injection.
Danish: Metalyse bør opløses ved at tilsætte den komplette mængde af solvens fra den fyldte injektionssprøjte til hætteglasset indeholdende pulveret til injektion.
English: Tel: +49 (0) 800 77 90 900
Danish: KG Tel: +49 (0) 800 77 90 900
English: Metalyse is not recommended for use in children (below 18 years) due to a lack of data on safety and efficacy.
Danish: Metalyse bør ikke anvendes til børn under 18 år pga mangelende dokumentation for sikkerhed og virkning.
English: Tell your doctor or pharmacist if you are taking,have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Tenecteplase (U)
Danish: Tenecteplase (E)
English: internal bleeding in the abdomen (retroperitoneal bleeding) bleeding in the brain (cerebral haemorrhage).
Danish: indre blødning i maven (retroperitoneal blødning) blødning i hjernen (cerebral hæmoragi).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL FOR SOLVENT
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL SPRØJTE MED SOLVENS
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.
Danish: Efter administration af tenecteplase observeres et dosisafhængigt forbrug af 2-antiplasmin (plasmins flydende faseinhibitor) med deraf følgende stigning i systemisk plasmingenerationsniveauerne.
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.
Danish: Metalyse er indiceret til trombolytisk behandling af mistænkt myokardieinfarkt hos voksne med vedvarende ST-elevation eller nylig venstresidig Bundle Branch Block inden for 6 timer efter debut på symptomer på akut myokardieinfarkt (AMI).
English: Ensure that the appropriate vial size is chosen according to the body weight of the patient.
Danish: Sikre at det rigtige hætteglas vælges i forhold til patientens legemsvægt
English: Death or permanent disability may occur following bleeding in the brain or other serious bleeding events bleeding in the eyes (eye haemorrhage)
Danish: Død eller permanent invaliditet kan forekomme efter blødning i hjernen eller andre alvorlige blødningstilfælde blødning i øjnene (hæmoragi i øjet)
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.
Danish: 20 ml hætteglas type I med en overtrukken (B2-42) grå gummistopper og en hætte, fyldt med pulver til injektionsvæske, opløsning.
English: The active substance is tenecteplase.
Danish: Aktivt stof: Tenecteplase.
English: Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
Danish: leversvigt, cirrose, portal hypertension (esofagale varicer) og aktiv hepatitis
English: As fibrin is lysed during tenecteplase therapy, bleeding from recent puncture site may occur.
Danish: Eftersom fibrin spaltes under tenecteplasebehandling kan blødning fra tidligere injektionssteder forekomme.
English: Not known(frequency cannot be estimated from the available data): fat embolism (clots consisting of fat) nausea vomiting body temperature increased (fever) blood transfusions as consequence of bleedings
Danish: Ikke kendt (hyppigheden kan ikke bestemmes ud fra de kendte data): - fedtemboli (”propper” bestående af fedt) - kvalme - opkastning - forhøjet legemstemperatur (feber) - blodtransfusioner, som en konsekvens af blødning
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.
Danish: Reperfusionsarytmier (såsom asystoli, accelereret idioventrikulær rytme, arytmi, ekstrasystoler, atrieflimren, atrioventrikulært blok af 1. grad til komplet atrioventrikulært blok, bradykardi, takykardi, ventrikulær arytmi, ventrikelflimren, ventrikulær takykardi) opstår i tæt tidsmæssig sammenhæng med tenecteplasebehandling.
English: SPECIAL STORAGE CONDITIONS Do not store above 30C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 °C.
English: Tenecteplase is an intravenously administered, recombinant protein that activates plasminogen.
Danish: Tenecteplase er et intravenøst administreret, rekombinant protein som aktiverer plasminogen.
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.
Danish: I sammenlignelige studier blev der observeret mindre end 15 % reduktion i fibrinogen og mindre end 25 % reduktion i plasminogen i forsøgspersoner behandlet med den maksimale dosis af tenecteplase (10.000 E sv.t.
English: What Metalyse contains
Danish: Metalyse indeholder:
English: Nervous system disorders Uncommon
Danish: Nervesystemet Ikke almindelig