FrancophonIA/ELRC3.0 huggingface dataset:
English: Two studies were in patients with chronic CML (198 and 36 patients), one was in accelerated CML (120 patients), one was in myeloid blast CML (80 patients), and one was in Ph+ ALL and lymphoid blast CML (81 patients).
Danish: Der blev foretaget to studier af kronisk CML (198 og 36 patienter), ét af accelereret CML (120 patienter), ét af myeloid blast-CML (80 patienter) og ét af Ph+-ALL- og lymfoid blast-CML (81 patienter).
English: Most of these studies assessed how well the leukaemia responded to treatment by measuring the levels of white cells and platelets in the blood, to see if they were returning to within normal levels, and by measuring the number of white blood cells that contained the Philadelphia chromosome, to see if it was decreasing.
Danish: I de fleste af studierne blev patienternes reaktion på behandlingen vurderet ved at måle, om antallet af hvide blodlegemer og blodplader var ved at vende tilbage til det normale, og om antallet af hvide blodlegemer, som indeholdt Philadelphiakromosomet, var faldende.
English: Another main study looked at the effectiveness of Sprycel in 113 children with Ph+ chronic phase CML, including 29 patients who could not use imatinib or it had not worked, as well as 84 newly diagnosed children who had not been previously treated.
Danish: Endnu et hovedstudie så på virkningen af Sprycel hos 113 børn med Ph+-CML i kronisk fase, herunder 29 patienter, der ikke kunne få eller ikke havde reageret på imatinib, samt 84 nydiagnosticerede børn, som ikke tidligere var blevet behandlet.
English: What benefits of Sprycel have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Sprycel?
English: A further study involving 519 patients compared Sprycel with imatinib in treating newly diagnosed Ph+ patients with chronic phase CML who had not received any previous treatment.
Danish: Endnu et studie med 519 patienter sammenlignede Sprycel med imatinib til behandling af nydiagnosticerede Ph+-patienter, som havde CML i kronisk fase og ikke tidligere havde fået nogen behandling.
English: Ph+ means that some of the patient's genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia.
Danish: Ph+ betyder, at nogle af patientens gener har omarrangeret sig og dannet et særligt kromosom, der kaldes Philadelphiakromosomet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sprycel have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Sprycel.
English: How does Sprycel work?
Danish: Hvordan virker Sprycel?
English: Other incompatibilities may also exist.
Danish: Andre uforligeligheder kan også forekomme.
English: Date of first authorisation: 29 August 1996 Date of last renewal: 29 August 2006
Danish: Dato for første tilladelse: 29. august 1996 Dato for sidste genregistrering: 29. august 2006
English: No interaction studies have been performed.
Danish: Ingen interaktionsstudier har været udført.
English: - age over 75 years
Danish: - alder over 75 år
English: Therefore, repeated use is not recommended.
Danish: Derfor anbefales gentagen anvendelse ikke.
English: Do not add any other medicines.
Danish: Tilsæt ikke andre lægemidler.
English: You must tell your doctor if you are pregnant or think you are pregnant.
Danish: De skal fortælle Deres læge, hvis De er gravid eller tror De er gravid.
English: The fibrinogen level normalises within 2 days.
Danish: Fibrinogen niveauet normaliseres inden for 2 dage.
English: 2 needles 19 G1
Danish: 2 nåle 19 G1
English: • age over 75 years
Danish: • er ældre end 75 år
English: The dose is now ready for intravenous administration.
Danish: Dosis er nu klar til intravenøs administration.
English: Local reactions at injection site can also occur.
Danish: Lokale reaktioner ved injektionsstedet kan også forekomme.
English: Visual inspection of the solution is necessary after reconstitution.
Danish: Visuel inspektion af opløsningen er nødvendig efter rekonstitution.
English: Reports of intracranial bleeding, many of which are fatal, are of particular concern.
Danish: Rapporter om intracraniale blødninger, hvoraf mange er fatale, er specielt bekymrende.
English: 20014 Nerviano (Milan) Italy
Danish: 20014 Nerviano (Milan) Italien
English: As with other plasminogen activators a rebound phenomenon then occurs during which fibrinogen levels reach a maximum within 9 days and remain elevated for up to 18 days.
Danish: Som med andre plasminogen aktivatorer ses et rebound fænomen under hvilken fibrinogen niveauet når et maksimum inden for 9 dage og forbliver forhøjet i optil 18 dage.
English: Be sure to tell hospital staff immediately if any of these symptoms appear.
Danish: Sørg for straks at meddele hospitalspersonalet, hvis nogle af disse symptomer viser sig.
English: • if you have had external heart massage within the past 10 days.
Danish: • hvis De har fået ekstern hjertemassage indenfor de sidste 10 dage
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis det ikke anvendes straks, er opbevaringstiden under anvendelse og opbevaringsbetingelserne forud for anvendelsen brugerens ansvar.
English: Therefore, be sure to tell the medical staff if you experience pain during the injection.
Danish: Husk derfor at fortælle sundhedspersonalet, hvis De mærker smerter under injektionen.
English: In the event of overdosage there may be an increased risk of bleeding.
Danish: I tilfælde af overdosering kan der være en forøget risiko for blødning.
English: • if you have severe uncontrolled high blood pressure (hypertension).
Danish: • hvis De har svært, ukontrolleret forhøjet blodtryk (hypertension)
English: The frequency of adverse reactions reported is listed in the following table.
Danish: Hyppigheden af de rapporterede bivirkninger er angivet i nedenstående tabel.
English: Your doctor can tell you the risks and benefits of using Rapilysin during pregnancy.
Danish: Lægen kan fortælle Dem om fordele og risici ved at anvende Rapilysin under graviditet.
English: Shelf-life as package for sale: 3 years.
Danish: Holdbarhed i salgspakning: 3 år
English: This medicinal product should not be mixed with Heparin and/or acetylsalicylic acid.
Danish: Dette lægemiddel må ikke blandes med heparin og/eller acetylsalicylsyre.
English: Each injection should be given slowly within 2 minutes.
Danish: Hver injektion gives langsomt indenfor 2 minutter.
English: Therefore tell the medical staff immediately if you
Danish: Derfor skal De straks fortælle lægen, hvis De
English: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois France
Danish: 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois Frankrig
English: If more Rapilysin is used than recommended
Danish: Hvis der anvendes mere Rapilysin end der anbefales:
English: Use aseptic technique throughout.
Danish: Aseptisk teknik anvendes under hele proceduren.
English: • severe allergic reaction, causing shock or collapse
Danish: ● Svær allergisk reaktion, som kan forårsage chok eller kollaps
English: Rapilysin is usually given in a hospital.
Danish: Rapilysin gives normalt på sygehuset.
English: Attention should be paid to this effect especially during periods of low plasma fibrinogen (up to about 2 days after fibrinolytic therapy of AMI).
Danish: Opmærksomheden bør henledes på denne effekt specielt i perioder med lav plasmafibrinogen (op til 2 dage efter fibrinolytisk behandling af AMI).
English: • if you have had a stroke.
Danish: • hvis De har haft et slagtilfælde
English: Instructions for use/handling
Danish: Instruktioner vedrørende anvendelse/håndtering
English: ** Recombinant plasminogen activator produced in Escherichia coli by recombinant DNA technology.
Danish: ** Rekombinant plasminogenaktivator produceret i Escherichia coli ved rekombinant DNA teknologi.
English: In the alteplase group 33.0 % were fatal and 39.8 % were disabling.
Danish: I alteplase gruppen var 33,0 % fatale og 39,8 % invaliderende.
English: Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30 °C after dissolving with water for injection.
Danish: Kemisk og fysisk stabilitet er påvist til 8 timer mellem 2° og 30 °C efter rekonstitution med vand til injektionsvæsker.
English: In addition, the second bolus of reteplase should not be given if the serious bleeding occurs before it is administered.
Danish: Desuden må den anden bolusinjektion med reteplase ikke gives, hvis alvorlig blødning indtræffer inden denne administreres.
English: Thrombolytic treatment may cause the heart to beat irregularly.
Danish: Trombolytisk behandling kan få hjertet til at slå uregelmæssigt.
English: Exact data on the main elimination routes for reteplase in humans are not available and the consequences of hepatic or renal insufficiency are not known.
Danish: Nøjagtige data om de væsentligste eliminationsveje for reteplase hos mennesker er ikke tilgængelige og konsekvensen af hepatisk og renal insufficiens er ikke kendt.
English: • any other condition in which bleeding might be especially dangerous or might occur at a site where it would be difficult to control
Danish: • andre tilstande, hvor blødning kan være særlig farlig eller kan forekomme et sted, hvor den vil være vanskelig at kontrollere
English: At present there is no experience with repeated use of Rapilysin.
Danish: På nuværende tidspunkt er der ingen erfaring med gentagen anvendelse af Rapilysin.
English: It is given within 12 hours after the onset of symptoms.
Danish: Det gives indenfor 12 timer efter, at symptomerne er begyndt.
English: • if you have other tumours associated with an increased risk of bleeding.
Danish: • hvis De har andre tumorer, der er forbundet med en forøget blødningsrisiko.
English: In the following conditions the risks of reteplase therapy may be increased and should be weighed against the anticipated benefits:
Danish: Under følgende betingelser kan der opstå forøget risiko ved reteplaseterapi og denne risiko skal opvejes mod de forventede fordele:
English: In dogs repeated dosing of the human peptide reteplase led to immunologic-allergic reactions.
Danish: Hos hunde førte gentagen indgift af human peptid reteplase til immunologiske-allergiske reaktioner.
English: This plasminogenolysis occurs preferentially in the presence of fibrin.
Danish: Denne plasminogenolyse sker hovedsagelig ved tilstedeværelse af fibrin.
English: Side effects of frequency not known (cannot be estimated from the available data) • Blockage of blood vessels due to cholesterol (fat)
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (kan ikke vurderes ud fra de tilgængelige data) ● Blokering af blodkar på grund af kolesterol (fedt)
English: White powder and clear colourless liquid (water for injections).
Danish: Hvidt pulver og klar farveløs væske (vand til injektionsvæsker).
English: In general, however, it is not necessary to replace the coagulation factors because of the relatively short half-life of reteplase.
Danish: Generelt er det dog ikke nødvendigt at tilføre erstatningsbehandling med koagulationsfaktorer, på grund af reteplases korte halveringtid.
English: These events can be life-threatening and may lead to death.
Danish: Disse hændelser kan være livstruende og dødelige.
English: In rats, a species insensitive to the pharmacological effects of reteplase, there were no adverse effects on fertility, embryo-foetal development and offspring.
Danish: Hos rotter, en art der er ufølsom overfor farmakologiske effekter af reteplase, var der ingen negative virkninger på fertilitet, embryo-føtal udvikling og afkom.
English: A pre- and postnatal toxicity study was not performed with reteplase.
Danish: Der blev ikke udført et præ- og postnatalt studie med reteplase.
English: Reteplase (10+10 U) dose-dependently reduces plasma fibrinogen levels by about 60 to 80 %.
Danish: Reteplase (10+10 E) reducerer dosis-afhængigt plasma fibrinogen niveauet med omkring 60-80 %.
English: Protamine should be considered if heparin has been administered within 4 hours of the onset of bleeding.
Danish: Protamin bør overvejes hvis heparin har været administreret indenfor 4 timer fra blødningstart.
English: - any other condition in which bleeding constitutes a significant hazard or would be particularly difficult because of its location
Danish: - andre tilstande, hvor blødning udgør en signifikant fare eller ville være særlig ondartet p.g.a. dets placering
English: Each patient being considered for therapy with reteplase should be carefully evaluated.
Danish: Patienter der overvejes til reteplase behandling bør nøje bedømmes.
English: • Burning sensation when Rapilysin is injected
Danish: • Brændende fornemmelse, når Rapilysin injiceres
English: The risks of Rapilysin treatment may be increased if you have any of the following conditions:
Danish: Risikoen ved behandling med Rapilysin kan øges, hvis De har en af følgende lidelser:
English: A target fibrinogen level of 1 g/l is desirable with cryoprecipitate or fibrinogen infusion.
Danish: Et fibrinogen niveau på 1g/l er ønsket med kryopræcipitat eller fibrinogen infusion.
English: The only relevant available animal data refer to studies performed in rabbits, which showed vaginal bleedings associated with abortions (see section 5.3).
Danish: De eneste tilgængelige relevante data med dyr omhandler forsøg udført med kaniner, hvilke viste vaginale blødninger forbundet med aborter (se pkt.
English: * Potency of reteplase is expressed in units (U) by using a reference standard which is specific for reteplase and is not comparable with units used for other thrombolytic agents.
Danish: 6.1 * Styrken af reteplase er udtrykt i enheden (E) ved brug af en referencestandard, som er specifik for reteplase og som ikke er sammenlignelig med enheder brugt for andre trombolytiske lægemidler.
English: Pharmacotherapeutic group: antithrombotic agent, ATC Code: B01AD07
Danish: Farmakoterapeutisk klassifikation: antithrombotisk middel, ATC-kode: B01AD07
English: Genotoxicity of reteplase was excluded by a complete battery of tests at different genetic end points in vitro and in vivo.
Danish: Genotoksiske blev udelukket gennem et complet testbatteri med forskellige genetiske endpoints in vitro og in vivo.
English: Treatment of children with Rapilysin is not recommended.
Danish: Behandling af børn med Rapilysin kan derfor ikke anbefales.
English: The use of rigid catheter as well as intramuscular injections and nonessential handling of the patient should be avoided during treatment with reteplase.
Danish: Brugen af ueftergiveligt kateter såvel som intramuskulære injektioner og unødvendig håndtering af patienten skal undgås under behandling med reteplase.
English: Plasminogen activator inhibitor 1 (PAI-1) activity can be reduced to around zero, but rapidly normalises within two hours showing a rebound phenomenon.
Danish: Plasminogen aktivator inhibitor 1 (PAI-1) aktiviteten kan være reduceret til omkring nul, men en hurtig normalisering indenfor 2 timer viser en rebound fænomen.
English: There are no adequate data on the use of reteplase in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af reteplase til gravide.
English: Prothrombin activation fragment 1 levels and thrombin-antithrombin III-complexes increase during thrombolysis indicating thrombin production of which the clinical relevance is unknown.
Danish: Prothrombin aktiveringsfragment 1. niveau og trombin-antitrombin III-kompleks forøges under trombolysen, hvilket indikerer en trombin produktion, hvis kliniske relevans er ukendt.
English: Treatment with Rapilysin 10 U should be started as soon as possible after the symptoms of heart attack begin.
Danish: Behandling med Rapilysin 10 E skal påbegyndes så hurtigt som muligt efter, symptomerne på et hjerteanfald er begyndt.
English: Therefore Rapilysin must be given only in the presence and under the instructions of an emergency doctor.
Danish: Derfor må Rapilysin kun gives i nærvær og under instruktion af en speciallæge.
English: 220 Hafnarfjordur Iceland.
Danish: 220 Hafnarfjordur
English: You should not breast-feed your baby during treatment with Rapilysin as it is not known whether Rapilysin is excreted into mother's milk.
Danish: De må ikke amme Deres barn under behandling med Rapilysin, da det ikke vides om Rapilysin udskilles i modermælken.
English: In the reteplase group, 49.4 % of these strokes were fatal and 27.1 % were disabling.
Danish: I reteplase gruppen var 49,4 % af disse apopleksi tilfælde fatale og 27,1 % var invaliderende.
English: Do not store above 25 °C Keep the vial in the outer carton in order to protect from light
Danish: Må ikke opbevares over 25 °C Opbevar hætteglasset i den ydre karton for at beskytte mod lys
English: In the event of overdosage one might expect depletion of fibrinogen and other blood coagulation components (e.g. coagulation factor V) with a consequent risk of bleeding.
Danish: I tilfælde af overdosering kunne man forvente en formindskelse af fibrinogen og andre blodkoaguleringskomponenter (f.eks. koagulations faktor V) med deraf følgende risiko for blødning.
English: For information on medicines that should not be physically mixed with Rapilysin solution for injection, see section 3.
Danish: For oplysninger om lægemidler, som ikke fysisk må blandes med Rapilysinopløsning til injektion (se punkt 3).
English: Repeated use
Danish: Gentagen anvendelse
English: • if you are taking medicine to thin your blood (oral anticoagulants, e.g. warfarin).
Danish: • hvis De tager medicin, som fortynder blodet (orale antikoagulantia, f.eks. warfarin)
English: The reconstituted solution contains 1 U reteplase per ml.
Danish: Den rekonstituerede opløsning indeholder 1E reteplase pr. ml.
English: Each bolus is administered as a slow intravenous injection within 2 minutes.
Danish: Hver bolus administreres som en langsom intravenøs injektion over højst 2 minutter.
English: Should serious bleeding, in particular cerebral haemorrhage, occur any concomitant heparin should be terminated immediately.
Danish: Skulle alvorlig blødning, især hjerneblødning, opstå, skal eventuel samtidig heparinbehandling seponeres omgående.
English: Discuss with your doctor when you can take up breast-feeding again.
Danish: Tal med lægen om, hvornår De kan begynde at amme igen.
English: Before use, the powder for injection must be dissolved in the water for injection supplied in the prefilled syringe that is in the package.
Danish: Før anvendelsen skal pulveret til opløsning opløses i vand til injektionsvæsker, som findes i den forfyldte sprøjte, der er i pakningen.
English: Pay careful attention to all possible bleeding sites (e.g. injection sites).
Danish: Vær særlig opmærksom på mulige blødningssteder (f.eks. injektionssteder).
English: Fat embolism, which may lead to corresponding consequences in the complications organs concerned4
Danish: Fedtemboli, der kan forårsage følgevirkninger i de implicerede organer4
English: Retrospective analyses of clinical studies did not reveal any clinically relevant interactions with medicinal product used concomitantly with reteplase in patients with acute myocardial infarction.
Danish: Retrospektive analyser af kliniske studier viste ingen klinisk relevante interaktioner med lægemidler samtidig anvendt med reteplase hos patienter med akut myokardie infakt.
English: - The active substance is reteplase 10U/10 ml after reconstitution.
Danish: - Aktivt stof: reteplase 10 E/10 ml efter rekonstitution.
English: Additional studies in human plasma samples in vitro suggest that complexation with C1-inactivator, α2-antiplasmin and α2-antitrypsin contributes to the inactivation of reteplase in plasma.
Danish: Yderligere studier på human plasmaprøver in vitro tyder på, at kompleksdannelse med C1 -inaktivator, α2-antiplasmin og α2-antitrypsin bidrager til inaktivering af reteplase i plasma.
English: No other medicines should be added to the injection solution (see below).
Danish: Ingen andre lægemidler må tilsættes injektionsopløsningen (se nedenfor).
English: Reductions of plasma levels of plasminogen and α2-antiplasmin normalise within 1 to 3 days.
Danish: Reduktion i plasma plasminogenniveau og α2-antiplasmin normaliseres indenfor 1 til 3 dage.
English: Transfusions of cryoprecipitate, fibrinogen, fresh frozen plasma and platelets should be considered with clinical and laboratory reassessment after each administration.
Danish: Transfusion med kryopræcipitat, fibrinogen, friskfrossen plasma og trombocytter bør klinisk og laboratoriemæssig overvejes med en vurdering efter hver administration.
English: If an anaphylactoid reaction occurs, the injection should be discontinued immediately and appropriate therapy should be initiated.
Danish: Hvis der indtræffer en anafylaktisk reaktion, skal injektionen straks afbrydes og passende behandling skal institueres.
English: The half-life of reteplase was increased in patients with AMI as compared to healthy volunteers.
Danish: Halveringtiden af reteplase var forøget hos patienter med AMI sammenlignet med raske forsøgspersoner.
English: Acute toxicity studies were performed in rats, rabbits and monkeys Subacute toxicity studies were performed in rats, dogs and monkeys.
Danish: Akut toksicitetsstudier blev udført på rotter, kaniner og aber, og subakutte toksicitetsstudier blev udført på rotter, hunde og aber.
English: In case of incompatibility an adaptor can be used and removed together with the glass syringe immediately after administration
Danish: I tilfælde af uforligelighed kan en adapter anvendes og fjernes sammen med glas-injektionssprøjten straks efter administration.
English: In rabbits, vaginal bleedings and abortions possibly associated to prolonged haemostasis, but no foetal abnormalities were noted.
Danish: Hos kaniner observeredes vaginale blødninger og aborter muligvis forbundet med forlænget hæmostase, men ingen føtale abnormaliteter.
English: Take the 10 ml syringe out of the package.
Danish: Tag 10 ml injektionssprøjten ud af pakningen.
English: The predominant acute symptom after single high doses of reteplase in rats and rabbits was transient apathy shortly after injection.
Danish: Det dominerende tegn på toksicitet, efter en enkelt højdosis af reteplase hos rotter og kaniner, var en forbigående apati kort efter injektionen.
English: Other medicines may also not mix well with Rapilysin.
Danish: Andre lægemidler kan måske heller ikke blandes med Rapilysin.
English: It is not known whether reteplase is excreted into breast milk.
Danish: Det vides ikke hvorvidt reteplase udskilles i modermælk.
English: • diseases of the blood vessels in the brain
Danish: • karsygdomme i hjernens blodkar
English: Coronary thrombolysis may result in arrhythmias associated with reperfusion.
Danish: Koronartrombolyse kan føre til arytmier, som associeres med reperfusion.
English: - cerebrovascular disease
Danish: - cerebrovaskulær sygdom
English: Therefore, the compatibility of the glass syringe and intravenous access should be ensured before use.
Danish: Forligelighed mellem glasinjektionssprøjten og intravenøs adgang bør derfor sikres før anvendelse.
English: No other medicines should be added to the injection solution.
Danish: Ingen andre lægemidler må tilsættes injektionsopløsningen.
English: At present, little data are available on the use of Rapilysin in patients with diastolic blood pressure higher than 100 mmHg.
Danish: På nuværende tidspunkt er der kun få data om anvendelsen af Rapilysin hos patienter med et diastolisk blodtryk højere end 100 mmHg.
English: As fibrin is lysed during reteplase therapy, bleeding from recent puncture sites may occur.
Danish: Da fibrin lyseres ved reteplaseterapi kan blødning fra friske punktursteder forekomme.