FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥
Danish: Hyppigheder defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000> til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: Experiments in rats indicate that the liver and the kidneys are the main organs of active uptake and lysosomal degradation.
Danish: Forsøg med rotter viser at lever og nyre er de væsenligste organer for aktiv optagelse og lysosomal nedbrydning.
English: • Bleeding around the heart, in the abdomen, the brain or the eyes, under the skin, from the nose or as coughed up blood
Danish: • Blødning omkring hjertet, i underlivet, i hjernen eller fra øjnene, under huden, fra næsen eller som ophostet blod
English: • systolic blood pressure higher than 160 mmHg
Danish: • systolisk blodtryk højere end 160 mmHg
English: Use the solution immediately after reconstitution
Danish: Anvend opløsningen umiddelbart efter rekonstitution
English: Safety and effectiveness of Rapilysin in children have not been established.
Danish: Sikkerhed og effekt af Rapilysin hos børn er endnu ikke dokumenteret.
English: It is a thrombolytic medicine used to dissolve blood clots that have formed in certain blood vessels and to restore the blood flow in these blocked vessels (=thrombolysis).
Danish: Det er et trombolytisk lægemiddel, som anvendes til at opløse blodpropper, som er dannet i visse blodkar og til at gendanne blodgennemstrømningen i de blokerede blodkar (trombolyse).
English: Therefore it should not be used except in life-threatening situations.
Danish: Derfor bør det ikke anvendes til gravide kvinder undtagen ved livstruende tilstande.
English: Ischaemic or haemorrhagic cerebrovascular events may be contributing or underlying conditions.
Danish: Iskæmiske eller hæmoragiske cerebrovaskulære hændelser kan være medvirkende eller underliggende faktorer.
English: A small amount of solution may remain in the vial due to overfill.
Danish: En mindre mængede opløsning kan være tilbage i hætteglasset på grund af overskud.
English: Open the package containing the reconstitution spike, remove both protective caps from the reconstitution spike.
Danish: Pakningen indeholdende rekonstitueringsnålen åbnes; fjern begge beskyttelseshætter fra rekonstitueringsnålen.
English: • if you have a bleeding disorder.
Danish: • hvis De har blødningssygdom
English: For further information see section 4.4, section bleeding.
Danish: 4.4, afsnittet om blødning.
English: Adverse reactions seen with reteplase
Danish: Bivirkninger set ved reteplase
English: The relative contribution of the inhibitors to inactivation of reteplase decreases as follows: C1-inactivator > α2antiplasmin > α2-antitrypsin.
Danish: Den relative fordeling af inhibitorer, der inaktiverer reteplase, mindskes som følger: C1-inaktivator > α2-antiplasmin > α2antitrypsin.
English: - recent gastrointestinal or genitourinary bleeding (within 10 days)
Danish: - nylig gastrointestinal eller urogenitalblødning (indenfor 10 dage)
English: Coagulation factor V, clotting factor VIII, α2-macroglobulin, and C1-esterase inhibitor are only slightly reduced and normalise within 1 to 2 days.
Danish: Koagulationsfaktor V, koagelfaktor VIII, α2-makroglobulin, og C1-esteraseinhibitor er kun let reduceret og normaliseres indenfor 1 til 2 dage.
English: Overall stroke rates were 1.64 % in the reteplase and 1.79 % in the alteplase group.
Danish: Incidensen af apopleksi var 1,64 % i reteplase gruppen og 1,79 % i alteplase gruppen.
English: Rapilysin is used after an acute myocardial infarction (heart attack) in order to dissolve the blood clot causing the heart attack.
Danish: Rapilysin anvendes efter et akut myokardieinfarkt (hjerteanfald) for at opløse den blodprop, som har forårsaget hjerteanfaldet.
English: Ensure that the injection is not mistakenly given paravenously.
Danish: Det skal sikres, at injektionen ikke ved en fejltagelse gives paravenøst.
English: Hypersensitivity reactions (e.g. allergic reactions)1
Danish: Overfølsomhedsreaktioner (f.eks. allergiske reaktioner)1
English: A clinical trial in approximately 15 000 patients comparing reteplase with the accelerated dose regimen of alteplase (GUSTO III) (2:1 randomisation reteplase: alteplase) did not show statistically different results for the primary endpoint of 30-day mortality (reteplase: 7.47 %, alteplase 7.23 %, p = 0.61) or for the combined endpoint of 30-day mortality and non-fatal disabling stroke (reteplase: 7.89 %, alteplase 7.88 %, p = 0.99).
Danish: En klinisk undersøgelse omfattende ca. 15.000 patienter sammenlignende reteplase med det akcellererede dosis regi af alteplase (GUSTO III) (2:1 randomisering, reteplase:alteplase) viste ingen statistisk forskellige resultater for det primære endpoint, 30 døgns mortalitet (reteplase: 7,47 %, alteplase: 7,23 %, p=0,61) eller for de kombinerede endpoints, 30 døgns mortalitet og ikke-fatalt invaliderende apopleksi (reteplase: 7,89 %, alteplsase: 7:88 %, p=0,99).
English: Animal data show that in case of severely impaired renal function with a pronounced increase in serum creatinine and serum urea an increase in half-life of reteplase has to be expected.
Danish: Dyrestudier viser at tilfælde med svær nedsat lever og nyrefunktion, med en udtalt forhøjet serumkreatinin og serumurea, kan en forøget halveringstid af reteplase forventes.
English: An additional increase of half-life of activity in patients with myocardial infarction and severely impaired liver and renal function cannot be excluded, but no clinical data of pharmacokinetics of reteplase in these patients are available.
Danish: En yderligere forøgelse af halveringtiden af aktiviteten hos patienter med myokardie infarkt og svær nedsat lever- og nyrefunktion kan ikke udelukkes, men kliniske farmakokinetiske data er ikke tilgængelige for reteplase.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser, bør dette præparat ikke blandes med andre præparater.
English: Dosage of Acetylsalicylic Acid
Danish: Dosering af acetylsalicylsyre
English: There was increased local haemorrhage at the injection site.
Danish: Der blev observeret øget lokal blødning ved injektionsstedet.
English: Subacute toxicity studies did not reveal any unexpected adverse events.
Danish: Subakut toksicitets studier viste ikke nogen uventede bivirkninger.
English: Mild impairment of renal function did not significantly affect the pharmacokinetic properties of reteplase.
Danish: Let nedsat nyrefunktion påvirkede ikke signifikant de farmakokinetiske egenskaber af reteplase.
English: Treatment with reteplase should be initiated as soon as possible after the onset of AMI symptoms.
Danish: Behandling med reteplase skal påbegyndes så hurtigt som muligt efter de første tegn på AMIsymptomer.
English: Serious anaphylaxis/anaphylactoid reactions1
Danish: Alvorlige anafylaktiske/anafylaktoide reaktioner1
English: - septic thrombophlebitis or occluded arteriovenous cannula at seriously infected site
Danish: - septisk tromboflebit eller tilstoppet arteriovenøs kanyle ved alvorligt inficeret sted
English: • if you have enlarged blood vessels in the gullet (oesophagus) (frequently caused by liver disease).
Danish: • hvis De har forstørrede blodkar i spiserøret (øsophagus)(ofte forårsaget af leversygdom)
English: Injury, poisoning and procedural
Danish: Traumer, forgiftninger og behandlingskomplikationer
English: Abnormal heart beats (arrhythmias)
Danish: Abnorme hjerteslag (arytmier)
English: delirium, agitation, confusion, depression, psychosis)
Danish: forvirring med hallucinationer, ophidselse, forvirring, depression, psykose)
English: The injection must not be given mistakenly outside the vein.
Danish: Injektionen må ikke ved en fejltagelse gives udenfor venen.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the vial after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen eller på hætteglassets etiket efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Heparin, which is given together with Rapilysin, may also increase bleeding.
Danish: Heparin, som gives samtidig med Rapilysin, kan også forstærke blødning.
English: In cynomolgus monkeys, the sedative effect ranged from slight apathy to unconsciousness, caused by a reversible dose-related drop in blood pressure.
Danish: I cynomolgus aber varierede den beroligende effekt fra mild apati til bevidstløshed, som forårsagedes af et reversibelt dosisrelateret blodtryksfald.
English: Incompatibility of some prefilled glass syringes (including Rapilysin) with certain needle free connectors has been reported.
Danish: Der er blevet rapporteret om uforligelighed mellem nogle fyldte glas-injektionssprøjter (inklusive nogle med Rapilysin) og visse nålefri forbindelseselementer.
English: There is no experience with Rapilysin in pregnant women.
Danish: Der foreligger ingen erfaringer med Rapilysin anvendt til gravide kvinder.
English: Dosage of Heparin
Danish: Dosering af Heparin
English: Most patients who have bleeding can be managed by interruption of thrombolytic and anticoagulant therapy, volume replacement and manual pressure applied to an incompetent vessel.
Danish: De fleste patienter som får blødning, kan behandles ved seponering af trombolytisk og antikoagulationsbehandling, volumensubstitution eller manuel tryk på insufficiente kar.
English: Plasmin in turn degrades fibrin, which is the main component of the matrix of thrombi, thereby exerting its thrombolytic action.
Danish: Plasmin nedbryder fibrin, som er hovedkomponenten af matrixen i en trombe, og udøver derved dens trombolytiske virkning.
English: • Chest Pain / angina, low blood pressure and heart failure /shortness of breath may reappear
Danish: • Smerter i brystet/angina, lavt blodtryk og hjertesvigt/kortåndethed kan komme igen
English: Heparin and Rapilysin cannot be mixed in the same solution.
Danish: Heparin og Rapilysin kan ikke blandes i den samme opløsning.
English: Rapilysin contains the active substance reteplase(a recombinant plasminogen activator).
Danish: Rapilysin indeholder det aktive stof reteplase (en rekombinant plasminogenaktivator).
English: A large comparative mortality trial (INJECT) in approx. 6000 patients showed that reteplase reduced the incidence of heart failure (secondary efficacy criterion) in a significant manner and was at least equally effective in terms of reducing mortality (primary efficacy criterion) when compared to streptokinase.
Danish: Et stort sammenlignings mortalitetsstudie (INJECT) med ca 6000 patienter viste at reteplase reducerer risikoen for hjertesvigt (sekundær effekt kriterie) signifikant og mindst lige så stor reduktion af mortalitet (primær effekt kriterie), sammenlignet med streptokinase.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: For opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De ønsker yderligere oplysninger om Rapilysin, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Mother's milk should be thrown away during the first 24 hours after thrombolytic treatment.
Danish: Modermælken bør bortkastes i de første 24 timer efter trombolytisk behandling.
English: • if you have severe liver or kidney disease.
Danish: • hvis De har svær lever- eller nyresygdom
English: Cerebral haemorrhage2
Danish: Cerebral blødning2
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på de fremstillere ansvarlige for batchfrigivelse
English: Therefore, thrombolytic therapy requires careful attention to all possible bleeding sites (including catheter insertion sites, arterial and venous puncture sites, cut down sites and needle puncture sites).
Danish: Derfor kræver trombolytisk terapi nøje overvågning af alle mulige blødningssteder (inklusiv indførselssteder fra venekateter, arterielle og venøse punktursteder, indsnitssteder for venekateter og kanylepunktursteder).
English: Reteplase is a recombinant plasminogen activator that catalyzes the cleavage of endogenous plasminogen to generate plasmin.
Danish: Reteplase er en rekombinant plasminogen aktivator, som katalyserer spaltningen af endogent forekommende plasminogen, hvilket danner plasmin.
English: The medicine is supplied in vials as a powder for injection.
Danish: Medicinen leveres i hætteglas som pulver til injektion.
English: Because thrombolytic therapy increases the risk of bleeding, reteplase is contra-indicated in the following situations: - known haemorrhagic diathesis - patients with current concomitant therapy with oral anticoagulants (e.g. warfarin sodium) - intracranial neoplasm, arteriovenous malformation or aneurysm - neoplasm with increased bleeding risk - history of cerebrovascular accident - recent (< 10 days) prolonged and vigorous external heart massage - severe uncontrolled hypertension - active peptic ulceration - portal hypertension (oesophageal varices) - severe liver or renal dysfunction - acute pancreatitis, pericarditis, bacterial endocarditis
Danish: Da trombolytisk terapi øger risikoen for blødning, er følgende situationer kontraindiceret for reteplase: - kendt hæmoragisk diatese - patienter som er i samtidig peroral antikoagulationsbehandling (f.eks. warfarinnatrium) - intrakranial neoplasme, arteriovenøs misdannelse eller aneurisme - neoplasma med forøget blødningsrisiko - tidligere cerebrovaskulær sygdom - nylig (< 10 dage) forlænget og kraftig udvendig hjertemassage - svær ukontrolleret hypertension - aktiv peptisk ulcus - portal hypertension (oesophagusvaricer) - svær lever- eller nyreinsufficiens - akut pancreatitis, pericarditis, bakteriel endocarditis
English: Tranexamic acid di-potassium-hydrogen phosphate phosphoric acid sucrose polysorbate 80
Danish: Tranexamsyre dikaliumhydrogenphosphat phosphorsyre saccharose polysorbat 80
English: • hypersensitivity (e.g. allergic reactions)
Danish: ● Overfølsomhed (f.eks. allergiske reaktioner)
English: Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 12 hours after the onset of acute myocardial infarction AMI symptoms.
Danish: Rapilysin er indiceret til trombolytisk behandling ved mistanke om myokardie infarkt med persisterende ST elevation eller nyligt opstået venstresidigt grenblok inden for 12 timer efter de første symptomer på akut myokardieinfarkt AMI.
English: Following intravenous bolus injection of 10 + 10 U in patients with acute myocardial infarction reteplase antigen is distributed in plasma with a dominant half-life (t1/2α) of 18±5 min and eliminated with a terminal half-life (t1/2ß) of 5.5 hours±12.5 min at a clearance rate of 121±25 ml/min.
Danish: Efter en intravenøs bolusinjektion på 10 + 10 E til patienter med akut myokardie infarkt sker distribuering af reteplase-antigen i plasma med en dominerende halveringstid (t1/2α) på 18±5 minutter og eliminering med en terminal halveringstid (t1/2β) på 5,5 timer ± 12,5 min ved en clearance hastighed på 121 ± 25 ml/min.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Danish: For vejledning vedrørende opløsning af lægemidlet før administration, se pkt.
English: Gastrointestinal haemorrhage (haematemesis, melena), gingival or genitourinary bleeding
Danish: Gastrointestinal blødning (hæmatemese, melæna), gingival eller urogenital blødning
English: Heparin and other medicines that thin the blood (anticoagulants) and acetylsalicylic acid (a substance used in many medicines used to relieve pain and lower fever) may increase the risk of bleeding.
Danish: Heparin og andre lægemidler, som fortynder blodet (antikoagulantia) og acetylsalicylsyre (et aktivt stof, der anvendes i mange lægemidler, der er smertelindrende eller febernedsættende) kan øge risikoen for blødning.
English: Available evidence on reteplase does not indicate an antibody-mediated origin of these hypersensitivity reactions.
Danish: Tilgængelig information om reteplase tyder ikke på, at disse overfølsomhedsreaktioner er antistofmedierede.
English: The reconstituted solution must be used immediately.
Danish: Den rekonstituerede opløsning skal anvendes umiddelbart.
English: Patients with systolic blood pressure over 160 mmHg have a greater risk of bleeding in the brain.
Danish: Patienter med et systolisk blodtryk over 160 mmHg har større risiko for hjerneblødning.
English: Reteplase 10 U (recombinant plasminogen activator, thrombolytic agent)
Danish: Reteplase 10 E (rekombinant plasminogenaktivator, trombolytisk middel)
English: The solution must be examined to ensure that only clear, colourless solution is injected.
Danish: Opløsningen skal inspiceres for at sikre at kun klare, farveløse opløsninger injiceres.
English: As with other thrombolytic agents these cardiovascular events have been reported as sequelae of myocardial infarction and/or thrombolytic administration.
Danish: Som ved andre trombolytiske midler er disse kardiovasulære hændelser blevet rapporteret som sequelae efter myokardieinfarkt og/eller trombolytisk behandling.
English: The concomitant use of heparin anticoagulation may contribute to bleeding.
Danish: Samtidig brug af heparin (antikoagulantia) kan bidrage til blødningen.
English: Rapilysin is given as a 10 U injection followed by a second 10 U injection 30 minutes later (double bolus).
Danish: Rapilysin gives som en 10 E injektion efterfulgt af endnu en 10 E injektion 30 minutter senere (dobbelt bolus).
English: The dose of acetylsalicylic acid given before Rapilysin should be at least 250 mg-350 mg and should be followed by 75-150 mg/day, at least until discharge from hospital.
Danish: Dosis af acetylsalicylsyre, som gives før Rapilysin, skal være mindst 250-350 mg, efterfulgt af 75150 mg daglig indtil udskrivning fra sygehuset.
English: Rapilysin should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor its use.
Danish: Rapilysin bør udskrives af læger med særligt kendskab til trombolytisk terapi og med monitoreringsmuligheder.
English: Heparin should be given for at least 24 hours, preferably for 48-72 hours, in order to keep aPTT values 1.5 to 2 times normal.
Danish: Heparin skal gives i mindst 24 timer, helst i 48-72 timer, for at holde aPTT værdierne på 1,5 til 2 gange det normale.
English: Reteplase is supplied as a freeze-dried substance in vials.
Danish: Reteplase leveres som frysetørret substans i hætteglas.
English: Actavis Italy S.p.A. Nerviano Plant Via Pasteur 10
Danish: Nerviano Plant Via Pasteur 10
English: - within 3 months of severe bleeding, major trauma or major surgery (e.g. coronary artery bypass graft, intracranial or intraspinal surgery or trauma), obstetrical delivery, organ biopsy, previous puncture of non-compressible vessels.
Danish: - inden for de sidste 3 måneder med svære blødninger, større trauma eller større kirurgiske indgreb (f.eks. koronar arteriel bypass operation, intrakranial eller intraspinal kirurgi eller trauma), fødsel, organbiopsi, tidligere punktur af ikke-kompressible kar.
English: The reconstituted preparation results in a clear, colourless solution.
Danish: Rekonstitueringen resulterer i en klar, farveløs opløsning.
English: 1 vial contains 10 U* reteplase ** in 0.56 g powder 1 prefilled syringe contains 10 ml water for injections.
Danish: 1 hætteglas indeholder 10 E* reteplase** i 0,56 g pulver 1 fyldt injektionssprøjte indeholder 10 ml vand til indsprøjtning.
English: Solvent: 10 ml Water for injection (prefilled syringe)
Danish: Solvens: 10 ml vand til injektionsvæsker (fyldt injektionssprøjte)
English: However, no antibody formation to the reteplase molecule has been observed.
Danish: Der er dog ikke observeret nogen antistofdannelse overfor reteplase molekylet.
English: Systolic blood pressure over 160 mmHg before thrombolysis with reteplase was associated with greater risk for cerebral bleeding.
Danish: Et systolisk blodtryk over 160 mmHg før trombolytisk behandling med reteplase var forbundet med en øget risiko for cerebral blødning.
English: Do not use Rapilysin
Danish: Tag ikke Rapilysin
English: • septic inflammation of a vein with blood clotting (septic thrombophlebitis) or blocked blood vessels at an infected site
Danish: • septisk betændelse af en vene med størkning af blodet (septisk årebetændelse) eller tilstoppede blodkar på et infektionssted
English: The most commonly reported adverse drug reaction associated with reteplase treatment is haemorrhage, predominantly at the injection site.
Danish: Den hyppigst rapporterede bivirkning efter behandling med reteplase er blødning, overvejende ved injektionsstedet.
English: Heparin, vitamin K antagonists and medicinal product that alter platelet function (such as acetylsalicylic acid, dipyridamole and abciximab) may increase the risk of bleeding if administered prior to, during or after reteplase therapy.
Danish: Heparin, vitamin K-antagonister og lægemidler, som påvirker trombocytternes funktion (såsom acetylsalicylsyre, dipyridamol og abciximab), kan øge blødnings- risikoen, hvis det gives før, i forbindelse med eller efter reteplasebehandlingen.
English: Haemorrhage at the injection site (e.g. haematoma), a local reaction at injection site, for example a burning sensation
Danish: Blødning på injektionsstedet (f.eks. hæmatom), lokal reaktion på injektionsstedet f.eks. en brændende fornemmelse.
English: Events related to the nervous system (e.g. epileptic seizure, convulsion, aphasia, speech disorder, delirium, acute brain syndrome, agitation, confusion, depression, psychosis)
Danish: Hændelser relateret til nervesystemet (såsom epileptiske anfald, kramper, afasi, taleforstyrrelser, delirium, akut hjernesyndrom, agitation, konfusion, depression, psykose)
English: This event has been reported for the therapeutic class of thrombolytic agents.
Danish: Denne hændelse har været rapporteret som klassebivirkning ved trombolytika.
English: • Damage to the heart or heart valves, or a blood clot in the lung, brain or other part of body mayoccur
Danish: ● Skader på hjertet eller hjerteklapper eller blodprop i lunger, hjerne eller andre dele af kroppen
English: • high likelihood of a blood clot in the heart (e.g. as a result of narrowing of a heart valve or atrial fibrillation)
Danish: • stor sandsynlighed for en blodprop i hjertet (fx på grund af forsnævring af en hjerteklap eller på grund af forkammerflimren)
English: The resulting solution must be used immediately.
Danish: Den færdige opløsning skal anvendes med det samme.
English: • if you are allergic to reteplase or any of the other ingredients of this medicine (listed in section
Danish: • hvis De er allergisk over for reteplase eller et af de øvrige indholdsstoffer i Rapilysin (angivet i punkt 6).
English: Contents of the pack and other information What Rapilysin contains
Danish: Pakningsstørrelser og yderligere oplysninger Rapilysin indeholder:
English: Heparin should be administered for at least 24 hours, preferably for 48 - 72 hours, aiming to keep aPTT values 1.5 to 2 times normal.
Danish: Heparin bør administreres over minimum 24 timer, helst over 48 - 72 timer, i forsøg på at holde en PTT værdi 1,5-2 gange normalværdien.
English: Heparin and Rapilysin are incompatible when combined in solution.
Danish: Heparin og Rapilysin er uforligelige, når de blandes i en opløsning.
English: The initial dose of acetylsalicylic acid prior to thrombolysis should be at least 250 mg (250 - 350 mg) followed by 75 - 150 mg/day at least until discharge.
Danish: Initialdosis for acetylsalicylsyre før trombolytisk behandling bør være på mindst 250 mg (250 mg-350 mg) efterfulgt af 75-150 mg daglig fortsættende minimum til udskrivning.
English: • feel palpitations or an irregular heart beat
Danish: • mærker hjertebanken eller uregelmæssige hjerteslag
English: 10 U reteplase
Danish: 10 E reteplase