FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefit has Pirsue shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Pirsue?
English: How has Pirsue been studied?
Danish: Hvordan blev Pirsue undersøgt?
English: The results of these studies showed that Pirsue is effective at inhibiting the bacterial growth of a range of bacteria.
Danish: Undersøgelsernes resultater viser, at Pirsue effektivt hæmmer væksten af en række bakterier.
English: Skin that has been in contact with Pirsue should be washed and eyes should be flushed with water for 15 minutes immediately after exposure.
Danish: Får man produktet i øjnene, skal man straks skylle øjnene med vand i 15 minutter.
English: In these studies, the effective concentration of pirlimycin required to stop bacterial growth was established.
Danish: I undersøgelserne blev det målt, hvor stor en koncentration af pirlimycin, der er nødvendig for at standse bakterievæksten.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Pirsue exceed the risks for the treatment of subclinical mastitis in lactating cows and recommended that Pirsue be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) fandt, at fordelene ved Pirsue opvejer risiciene til behandling af subklinisk yverbetændelse hos mælkegivende køer.
English: How does Pirsue work?
Danish: Hvordan virker Pirsue?
English: If any of these occur while you are taking [Invented name] by mouth, then stop taking [Invented name] and seek immediate medical advice.
Danish: Hvis noget af dette forekommer, mens du tager [særnavn] gennem munden, skal du stoppe med at tage [særnavn] og straks søge læge eller skadestue.
English: Although the two effects actually have the same results, the first is the most important.
Danish: Selvom de to virkninger faktisk har samme resultater, er den første den vigtigste.
English: Most of its effects are probably due to this structural similarity.
Danish: Hovedparten af dens virkning skyldes sandsynligvis denne strukturelle lighed.
English: Children (0-17 years):
Danish: Børn (0-17 år):
English: Unknown frequency:
Danish: Ukendt hyppighed:
English: * frequency not known (cannot be estimated from the available data).
Danish: * hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The symptoms of a severe allergic reaction may include:
Danish: Symptomer på en alvorlig, allergisk reaktion kan omfatte:
English: Not known*
Danish: Ikke kendt*
English: The safety and efficacy of EACA in children aged 0 to 17 years have not been established.
Danish: EACA's sikkerhed og virkning hos børn i alderen 0-17 år er ikke klarlagt.
English: All these events have also been described as part of the natural evolution of SAH, as a result of diagnostic procedures such as angiography.
Danish: Alle disse hændelser har også været beskrevet som del af den naturlige udvikling af SAH som resultat af diagnostiske procedurer såsom angiografi.
English: Rapid infusion
Danish: Hurtig infusion
English: Please note that these instructions may also apply to medication that you have used before or you can use later.
Danish: Bemærk, at dette også kan gælde for medicin, som du har taget tidligere eller vil tage senere.
English: - Coagulation factors (Factor IX)
Danish: - koagulationsfaktorer (faktor IX).
English: This test is negative in primary fibrinolysis.
Danish: Testen er negativ ved primær fibrinolyse.
English: • If you need long-term treatment, since muscle alterations may appear.
Danish: • Hvis du har brug for langvarig behandling, da der kan forekomme forandringer i musklerne.
English: There is no need for dose adjustment in elderly patients.
Danish: Der er ikke behov for dosisjustering til ældre patienter.
English: An intravenous dose of 2.3 g/kg was fatal in dogs.
Danish: En intravenøs dosis på 2,3 g/kg var dødelig hos hunde.
English: Hypotension Bradycardia
Danish: Hypotension Bradykardi
English: • pain or skin death at the injection site
Danish: • smerter eller død hud ved injektionsstedet.
English: Some patients have tolerated doses of up to 100 g, while cases of acute kidney failure have been described after a dose of 12 g.
Danish: Nogle patienter har tolereret doser på op til 100 g, mens der er beskrevet tilfælde af akut nyresvigt efter en dosis på 12 g.
English: Neurological effects
Danish: Neurologiske virkninger
English: • If bleeding is due to a condition called disseminated intravascular coagulation.
Danish: • hvis blødningen skyldes en tilstand, der hedder dissemineret, intravaskulær koagulation.
English: System organ class
Danish: Systemorgan-klasse Almindelig
English: Rapid intravenous administration should be avoided, as it can cause hypotension, bradychardia and/or arrhythmias.
Danish: Hurtig, intravenøs administration skal undgås, da det kan forårsage hypotension, bradykardi og/eller arytmi.
English: When skeletal myopathy occurs, the possibility of damage to the cardiac muscle must also be considered.
Danish: Hvis skeletmyopati indtræffer, skal risikoen for beskadigelse af hjertemusklen også overvejes.
English: Plasmin can act on other clotting system components such as factors V and VIII and, in particular, fibrinogen.
Danish: Plasmin kan virke på andre komponenter i koagulationssystemet, såsom faktor V og VIII og især fibrinogen.
English: This drug must not be administered without a definitive diagnosis and/or laboratory findings indicating hyperfibrinolysis (hyperplasminaemia).
Danish: Lægemidlet må ikke administreres uden en definitiv diagnose og/eller laboratoriefund, der indikerer hyperfibrinolyse (hyperplasminæmi).
English: Symptoms may include severe sore throat with high fever.
Danish: Symptomer kan omfatte alvorlig halsbetændelse med høj feber.
English: The following adverse reactions have been reported from clinical trials, post-authorisation safety studies and from spontaneously-reported cases with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Følgende bivirkninger er rapporteret fra kliniske studier, sikkerhedsstudier efter godkendelse og spontant rapporterede tilfælde med følgende hyppigheder: 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) samt “ikke kendt”:
English: • If you are allergic to aminocaproic acid or to any of the other ingredients of this medicine.
Danish: • hvis du er allergisk over for aminocapronsyre eller et af de øvrige indholdsstoffer i lægemidlet
English: Fertility There are no clinical data on the effects of [invented name] on fertility.
Danish: Fertilitet Der er ingen kliniske data fra [særnavn]s virkning på fertiliteten.
English: The clinical relevance of these findings is unknown (see section 5.3).
Danish: Den kliniske relevans af disse fund er ukendt (se pkt.
English: Elderly patients and patients with renal failure:
Danish: Ældre patienter og patienter med nedsat nyrefunktion:
English: One case of heart and liver damage has been described in humans.
Danish: Der er rapporteret ét tilfælde af hjerte- og leverskade hos mennesker.
English: It has been shown that there are evident relationships between the proteolytic activity of plasmin and the system that forms quinines, polypeptides with different biological effects basically related to inflammation and allergy.
Danish: Det er påvist, at der er tydelige forbindelser mellem plasmins proteolytiske aktivitet og det system, der danner kininer, polypeptider med forskellige biologiske virkninger, der grundlæggende er relateret til inflammation og allergi.
English: After intravenous administration, tonic-clonic seizures were observed in dogs and mice.
Danish: Efter intravenøs administration blev der observeret tonisk-kloniske kramper hos hunde og mus.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg lægen eller apotekspersonalet til råds, før du tager nogen form for medicin.
English: The single dose of aminocaproic acid that produces overdose symptoms or considered to be life threatening is unknown.
Danish: Enkeltdosis af aminocapronsyre, der fremkalder symptomer på overdosering eller anses som livstruende, er ukendt.
English: If any of these occur during administration of [Invented name] your doctor/surgeon will stop treatment with the drug.
Danish: Hvis noget af dette forekommer, mens du får [særnavn], vil lægen/kirurgen stoppe behandlingen med lægemidlet.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: - Hormonal medication such as oestrogens
Danish: - hormonpræparater, såsom østrogen
English: If you are pregnant, thinking about becoming pregnant or are breastfeeding, ask your doctor or pharmacist before starting this treatment.
Danish: Hvis du er gravid, planlægger at blive gravid eller ammer, skal du spørge din læge eller apoteket til råds, før du bruger dette lægemiddel.
English: Therapeutic subgroup: Antihemorrhagics Pharmacotherapeutic group: Antifibrinolytics ATC code: B02AA01.
Danish: Terapeutisk undergruppe: Midler mod blødning Farmakoterapeutisk klassifikation: Antifibrinolytika ATC-kode: B02AA01.
English: • heart surgery (with or without bypass placement)
Danish: • hjerteoperation (med eller uden anlæggelse af bypass)
English: Tell your doctor and stop using [invented name] if you experience:
Danish: Fortæl det til lægen, og hold op med at tage [særnavn], hvis du får:
English: It is widely distributed (it easily spreads to the tissues, appearing in semen, synovial fluid and foetal tissue) and it is excreted in urine, largely unaltered, with a terminal elimination half life of approximately 2 hours.
Danish: Det fordeles bredt (det spredes nemt til væv, fremkommer i sæd, synovialvæske og fostervæv) og udskilles i urinen, stort set uændret, med en terminal eliminationshalveringstid på ca. 2 timer.
English: The following tests can be performed to distinguish between the two disorders: - Platelet count: it is usually reduced in DIC but not in primary fibrinolysis.
Danish: Følgende test kan udføres for at skelne mellem de to tilstande: - Trombocyttal: Dette er normalt reduceret ved DIC, men ikke ved primær fibrinolyse.
English: • or a collapse.
Danish: • eller kollaps.
English: • skin rash with small, flat, red spots;
Danish: • hududslæt med små, flade, røde pletter
English: The maximum daily dose should not exceed 24 g.
Danish: Den maksimale daglige dosis må ikke overstige 24 g.
English: • gastroenterology
Danish: • gastroenterologi
English: CPK must be monitored in patients undergoing prolonged treatment.
Danish: CK skal monitoreres hos patienter i langvarig behandling.
English: Effects on ability to drive and use machines No studies have been conducted on the effects on the ability to drive and use machines.
Danish: Virkning på evnen til at føre motorkøretøj eller betjene maskiner Der er ikke foretaget studier af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: • gynaecology (cervical surgery), in patients where tranexamic acid is not available or not tolerated
Danish: • gynækologi (operation i livmoderhalsen) hos patienter, hvor tranexamsyre ikke er til rådighed eller ikke tåles
English: The patient received 2 g of aminocaproic acid every 6 hours to make a total dose of 26 g. The patient died from prolonged cerebrovascular haemorrhage.
Danish: Patienten fik 2 g aminocapronsyre hver 6. time til en samlet dosis på 26 g. Patienten døde af langvarig hjerneblødning.
English: The consequences ranged from absence of effects and transient hypotension to acute renal failure resulting in death.
Danish: Konsekvenserne varierede fra manglende virkning og forbigående hypotension til akut nyresvigt, der medførte død.
English: In case of overdose with <Aminocaproic acid-containing medicinal products>, tell your doctor or pharmacist immediately, go to the nearest hospital.
Danish: I tilfælde af overdosering med <lægemidler, der indeholder aminocapronsyre> skal du straks fortælle det til lægen eller på apoteket eller tage på nærmeste hospital.
English: • If you have haematuria (blood in urine) from the upper urinary tract.
Danish: • Hvis du har blod i urinen (hæmaturi) fra de øvre urinveje.
English: Aminocaproic acid is rapidly absorbed when administered orally and its peak plasma concentrations are reached after two hours.
Danish: Aminocapronsyre absorberes hurtigt, når det administreres oralt, og den maksimale plasmakoncentration nås efter to timer.
English: Thrombophlebitis, a possibility with all intravenous treatments, should be avoided, paying special attention to appropriate needle insertion and fixation.
Danish: Tromboflebitis, der er en risiko ved alle intravenøse behandlinger, bør undgås ved at udvise særlig opmærksomhed på korrekt indstik og fiksering.
English: Total dosage should not exceed 18 g/m2 (600 mg/kg) in 24 hours.
Danish: Den samlede dosis må ikke overstige 18 g/m2 (600 mg/kg) i løbet af 24 timer.
English: Carcinogenesis, mutagenesis and fertility disorders: No long-term studies have been conducted in animals to evaluate the carcinogenic or mutagenic potential of aminocaproic acid.
Danish: Karcinogenicitet, mutagenicitet og fertilitetsanomalier: Der er ikke udført langvarige dyrestudier for at evaluere aminocapronsyres karcinogene eller mutagene potentiale.
English: • dark-coloured urine, decreased amount or frequency of urine
Danish: • mørkfarvet urin, nedsat mængde urin eller færre vandladninger
English: The most important affect the fibrinolytic enzyme system, the mechanism responsible for dissolving fibrin meshes and, therefore, clots.
Danish: Den vigtigste er påvirkning af det fibrinolytiske enzymsystem, den mekanisme, der opløser fibrin og dermed koagler.
English: Aminocaproic acid should therefore not be administered in case of haematuria originating in the upper urinary tract unless the expected benefits more than exceed the risks.
Danish: Aminocapronsyre må derfor ikke administreres ved hæmaturi, der har oprindelse i de øvre urinveje, medmindre de forventede fordele klart overstiger risiciene.
English: The concomitant administration of clotting factors (Factor IX) and oestrogens can increase the risk of thrombosis.
Danish: Administration sammen med koagulationsfaktorer (faktor IX) og østrogener kan øge risikoen for trombose.
English: Allergic reactions may occur uncommonly in patients receiving [Invented name] (in fewer than 1 in 100 patients but more than 1 in 1000 patients).
Danish: Der kan forekomme allergiske reaktioner hos patienter, der får [særnavn], men det er ikke almindeligt (forekommer hos færre end 1 ud af 100 patienter, men hos flere end 1 ud af 1.000 patienter).
English: Aminocaproic acid is an amino acid that is structurally similar to other physiological amino acids, especially two fundamental amino acids, lysine and arginine.
Danish: Aminocapronsyre er en aminosyre, der strukturelt minder om andre fysiologiske aminosyrer, især to fundamentale aminosyrer, lysin og arginin.
English: Warnings and precautions .
Danish: Advarsler og forsigtighedsregler
English: • increased pressure in the brain that can result in severe headache, visual disturbance,
Danish: • øget tryk i hjernen, der kan give kraftig hovedpine, synsforstyrrelser, opkastning, svimmelhed,
English: - Protamine paracoagulation test: positive in DIC; a precipitate forms when a drop of protamine sulphate is added to “citrate” plasma.
Danish: - Protamin-parakoagulationstest: positiv ved DIC; en udfældning dannes, hvis der tilsættes en dråbe protaminsulfat til citratplasma.
English: The intravenous and oral lethal dose 50 of aminocaproic acid was 3 and 12 g/kg, respectively, in mice and 3.2 and 16.4 g/kg, respectively, in rats.
Danish: Den intravenøse og orale dødelige dosis50 (LD50) for aminocapronsyre var henholdsvis 3 og 12 g/kg hos mus og henholdsvis 3,2 og 16,4 g/kg hos rotter.
English: It is unknown whether epsilon aminocaproic acid is excreted in human milk.
Danish: Det er ukendt, om epsilon-aminocapronsyre udskilles i human mælk.
English: It has been suggested that extravascular clots formed in vivo may not undergo spontaneous lysis like normal clots.
Danish: Det tyder på, at ekstravaskulære koagler, der dannes in vivo, ikke undergår spontan lyse ligesom normale koagler.
English: - Aminocaproic acid should not be used in DIC without the concomitant administration of heparin.
Danish: - Aminocapronsyre bør ikke anvendes ved DIC uden samtidig indgivelse af heparin.
English: • urology (surgery of the bladder and prostate)
Danish: • urologi (operation i blære og prostata)
English: • obstetrics (post-partum and post-miscarriage haemorrhages) after correction of the coagulation defect
Danish: • obstetrik (blødning postpartum og efter abort) efter korrektion af koagulationsdefekten
English: - Euglobulin clot test: abnormal in primary fibrinolysis and normal in DIC.
Danish: - Euglobulin-koagulationstest: unormal ved primær fibrinolyse og normal ved DIC.
English: The administration of the equivalent to the maximum therapeutic dose in humans in the diet of rats caused fertility disorders in both sexes.
Danish: Administration af en dosis, der svarer til den maksimale terapeutiske dosis til mennesker, i maden til rotter forårsagede fertilitetsanomalier hos begge køn.
English: • swelling of your eyelids, face, lips and tongue
Danish: • hævelse af øjenlåg, ansigt, læber og tunge
English: On rare occasions, skeletal muscle weakness with muscular fibre necrosis has been described after prolonged administration.
Danish: I sjældne tilfælde har der været beskrevet svækkelse af skeletmuskler med nekrose af muskelfibre efter langvarig administration.
English: • heavy menstrual periods;
Danish: • kraftige menstruationer
English: 6.2 Incompatibilities [Invented name] should not be used with levulose solutions, solutions containing penicillin or with blood.
Danish: 6.2 Uforligeligheder [Særnavn] bør ikke anvendes sammen med fructoseinfusionsvæsker, med injektionsvæsker indeholdende penicillin eller med blod.
English: Nonsurgical haematuria of the lower urinary tract (secondary to cystitis, etc.).
Danish: Ikke-kirurgisk hæmaturi i de nedre urinveje (sekundært til cystitis osv.).
English: Aminocaproic acid is not very toxic, so intoxication can only occur in very exceptional cases, such as in cases of relative overdose with kidney failure.
Danish: Aminocapronsyre er ikke udpræget toksisk, så intoksikation vil kun forekomme i meget få exceptionelle tilfælde, såsom i tilfælde af relativ overdosering ved nedsat nyrefunktion.
English: However, it should be administered with precaution in cases in which the existence of thrombosis or embolism is suspected, and in renal failure.
Danish: Det skal imidlertid administreres med forsigtighed ved mistanke om trombose eller emboli samt ved nyresvigt.
English: There are no or limited amount of data from the use of epsilon aminocaproic acid in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af epsilon-aminocapronsyre til gravide kvinder.
English: The condition remits after administration is suspended; however, the syndrome may recur if the administration of aminocaproic acid is resumed.
Danish: Tilstanden remitterer, når administrationen ophører, men syndromet kan recidivere, hvis administrationen af aminocapronsyre genoptages.
English: In fact, the appearance or persistence of a haemorrhage could be, and in many cases is, due to local hyperfibrinolysis, especially when the haemorrhage is in organs rich in plasminogen activators, such as the uterus, prostate, lung, urinary tract, etc. On the other hand, aminocaproic acid has been shown to have a beneficial effect on general haemorrhages, such as those of a haematological origin, in which no hyperfibrinolysis is found in circulating blood.
Danish: Faktisk kan forekomst af eller persisterende blødning være - og er i mange tilfælde - forårsaget af lokal hyperfibrinolyse, især ved blødning i organer, der har mange plasminogenaktivatorer, såsom uterus, prostata, lunger, urinveje osv. På den anden side er det vist, at aminocapronsyre har en gavnlig virkning på generelle blødninger, såsom af hæmatologisk oprindelse, hvor der ikke er fundet hyperfibrinolyse i det cirkulerende blod.
English: Aminocaproic acid inhibits the effect of plasminogen activators and, to a lesser extent, plasmin activity.
Danish: Aminocapronsyre hæmmer effekten af plasminogenaktivatorer og i mindre grad plasminaktiviteten.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN [Udfyldes nationalt]
English: Inhibition of plasmin activity
Danish: Hæmning af plasminaktivitet
English: Some cases of acute overdose have been described after the intravenous administration of aminocaproic acid.
Danish: Der er beskrevet nogle tilfælde af akut overdosering efter intravenøs administration af aminocapronsyre.
English: No treatment is known for overdose, although there is evidence that aminocaproic acid is eliminated by haemodialysis and can be eliminated by peritoneal dialysis.
Danish: Der er ingen kendt behandling af overdosering, selvom der er tegn på, at aminocapronsyre elimineres via hæmodialyse og kan elimineres via peritonealdialyse.
English: Therapeutic indications
Danish: Terapeutiske indikationer
English: However, the anti-haemorrhagic effect of aminocaproic acid is not necessarily linked to the presence of fibrinolysis in blood shown by the respective tests.
Danish: Men aminocapronsyrens antihæmoragiske virkning er ikke nødvendigvis bundet til tilstedeværelsen af fibrinolyse i blod, som det kan ses med de respektive test.
English: • unusual aches or pains in your muscles that go on for longer than you might expect (as these can result in kidney problems and potentially life-threatening muscle damage [rhabdomyolysis])
Danish: • usædvanlige smerter i musklerne, der varer længere, end du forventer (dette kan skyldes nyreproblemer og muligvis livstruende muskelskade [rabdomyolyse]).
English: Aminocaproic acid has multiple pharmacological effects.
Danish: Aminocapronsyre har adskillige farmakologiske virkninger.
English: • hallucinations
Danish: • hallucinationer
English: DATE OF REVISION OF THE TEXT [To be completed nationally
Danish: DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt]
English: • reduction in blood platelets which increases risk of bleeding or bruising
Danish: • nedsat antal blodplader med øget risiko for blødning eller blå mærker
English: Like all medicines, aminocaproic acid can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If you use more <Aminocaproic acid-containing medicinal products> than you should If you take more <Aminocaproic acid-containing medicinal products> than you should, you may experience a sudden decrease in blood pressure (hypotension), with symptoms including dizziness, fainting, lightheadedness, blurred vision, a rapid, or irregular heartbeat (palpitations), confusion, feeling like you are going to be sick (nausea) or general weakness.
Danish: Hvis du har brugt for meget <lægemiddel, der indeholder aminocapronsyre> Hvis du har brugt for meget <lægemiddel, der indeholder aminocapronsyre>, kan du få pludseligt blodtryksfald (hypotension) med symptomer som svimmelhed, besvimelse, omtågethed, sløret syn, hurtige, uregelmæssige hjerteslag (hjertebanken), forvirring, kvalme eller generel svækkelse.
English: In this case, the medicinal product should be adjusted to the degree of kidney failure, or eventually be discontinued.
Danish: I sådanne tilfælde skal dosis justeres svarende til graden af nyrefunktionsnedsættelse, eller lægemidlet eventuelt seponeres.
English: [See Annex I - To be completed nationally]
Danish: [Se Bilag I - Udfyldes nationalt]