FrancophonIA/ELRC3.0 huggingface dataset:
English: Establishing cause of haemorrhage When there are doubts regarding whether the aetiology of the haemorrhage which [Invented name] is being used to manage is primary fibrinolysis or disseminated intravascular clotting (DIC), this should be clarified before administering aminocaproic acid.
Danish: Bestemmelse af årsagen til blødningen Hvis der er tvivl, om ætiologien af den blødning, som [særnavn] anvendes til at behandle, er primær fibrinolyse eller dissemineret, intravaskulær koagulation (DIC), skal det afklares inden administration af aminocapronsyre.
English: The literature contains publications about an increased incidence of certain neurological deficits such as hydrocephaly, cerebral ischaemia or cerebral vasospasm associated to the use of antifibrinolytic agents in the treatment of subarachnoid haemorrhage (SAH).
Danish: Litteraturen indeholder publikationer om øget forekomst af visse neurologiske deficitter som f.eks. hydrocefalus, cerebral iskæmi eller cerebral vasospasme i forbindelse med anvendelse af antifibrinolytika til behandling af subaraknoidal blødning (SAH).
English: Instead, it appears that said intravascular clotting was probably due to a pre-existing clinical condition, i.e. the presence of DIC.
Danish: Det lader til gengæld til, at den påståede intravaskulære koagulation sandsynligvis skyldtes en eksisterende klinisk tilstand, f.eks. dissemineret, intravaskulær koagulation (DIC).
English: Aminocaproic acid has an inhibitor effect on this system, which takes place on two levels: on the one hand, at relatively low concentrations, it inhibits the action of plasminogen activators by a competitive mechanism; on the other, at higher concentrations it inhibits plasmin activity.
Danish: Aminocapronsyre har en hæmmende virkning på dette system, hvilket foregår på to niveauer: På den ene side hæmmer lægemidlet ved relativt lave koncentrationer plasminogenaktivatorernes virkning ved en kompetitiv mekanisme.
English: Laboratory tests: the administration of aminocaproic acid can alter the results of platelet function tests.
Danish: Laboratorieprøver: Administration af aminocapronsyre kan ændre resultaterne af trombocytfunktionstest.
English: Confusion, seizures, delirium, hallucinations, intracranial hypertension, stroke, syncope
Danish: Konfusion, krampeanfald, delirium hallucinationer, intrakraniel hypertension, apopleksi, synkope
English: • bleeding from the lower urinary tract not caused by surgery (e.g. due to inflammation of the bladder);
Danish: • blødning i de nedre urinveje, der ikke skyldes operation (f.eks. på grund af blærebetændelse)
English: You may also uncommonly experience a decrease in white blood cells, which can increase the risk of infection.
Danish: Du kan også få et nedsat antal hvide blodlegemer, hvilket kan øge risikoen for infektion, men det er ikke almindeligt.
English: Elevated CPK, myositis
Danish: Forhøjet CK, myositis
English: One patient with a history of brain tumour and seizures presented seizures after receiving a bolus injection of 8 g of aminocaproic acid.
Danish: En patient med tidligere tilfælde af hjernetumor og krampeanfald fik krampeanfald efter at have fået en bolusinjektion på 8 g aminocapronsyre.
English: Administration with Factor IX complex concentrate or anti-inhibitor clotting concentrates Aminocaproic acid should not be administered with Factor IX complex concentrate or anti-inhibitor clotting concentrates, as it could increase the risk of thrombosis.
Danish: Administration sammen med faktor IX-komplekskoncentrat eller antiinhibitor-koagulationskoncentrater Aminocapronsyre bør ikke administreres sammen med faktor IX-komplekskoncentrat eller antiinhibitor-koagulationskoncentrater, da det kan øge risikoen for trombose.
English: Do not use a double dose to make up for a forgotten dose but continue to use the vials as usual.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Elderly patients Dose reductions are not necessary other than in cases of kidney failure.
Danish: Ældre patienter Dosisreduktion er kun nødvendigt i tilfælde af nedsat nyrefunktion.
English: <Aminocaproic acid-containing medicinal products> is used to prevent blood loss due to excessive bleeding in patients of all ages.
Danish: <Lægemidler, der indeholder aminocapronsyre> anvendes til at forebygge blodtab, der skyldes kraftig blødning, hos patienter i alle aldre.
English: If treatment needs to be extended, the maximum dose over 24 hours should not normally exceed 24 g.
Danish: Hvis langvarig behandling er nødvendig, må den maksimale dosis normalt ikke overstige 24 g i løbet af 24 timer.
English: The pharmacokinetic studies show that total body clearance of aminocaproic acid is highly diminished in patients with acute kidney failure.
Danish: Farmakokinetiske studier viser, at den totale udskillelse af aminocapronsyre er stærkt nedsat hos patienter med akut nyresvigt.
English: Numerous clinical studies show that aminocaproic acid has no thrombogenic effect.
Danish: Adskillige kliniske studier viser, at aminocapronsyre ikke har nogen trombogen effekt.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from aminocaproic acid therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med aminocapronsyre seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: • decrease in blood pressure;
Danish: • blodtryksfald
English: Aminocaproic acid has been observed to give rise to teratogenic effects in rats.
Danish: Det er observeret, at aminocapronsyre har medført teratogen virkning hos rotter.
English: As a result of these effects, aminocaproic acid prevents clot destruction by plasmin and thus prevents the appearance of haemorrhages due to excessive fibrinolytic system activity.
Danish: Som resultat af disse virkninger forebygger aminocapronsyre plasmins koageldestruktion og forebygger dermed fremkomst af blødninger, der skyldes for stor aktivitet af det fibrinolytiske system.
English: Aminocaproic acid is indicated for use in patients of all ages in haemorrhage caused by local or general fibrinolysis, including in Postsurgical haemorrhages in:
Danish: Aminocapronsyre (EACA) er indiceret til patienter i alle aldre med blødning, der skyldes lokal eller generel fibrinolyse, inklusive til postoperativ blødning ved:
English: [If applicable] <[In oral administration, the content of the ampoule can be drunk as it is or mixed with a little sugared water, broth, milk, etc.]>
Danish: [Hvis relevant] <[Ved oral administration kan ampullens indhold drikkes rent eller blandes med lidt sukkervand, bouillon, mælk el.
English: Leukopenia, thrombocytopenia
Danish: Leukopeni, trombocytopeni
English: Very rare (affects less than 1 in 10,000 patients):
Danish: Meget sjældne (påvirker færre end 1 ud af 10.000 patienter):
English: Marketing Authorisation Holder and Manufacturer [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: Indehaver af markedsføringstilladelsen og fremstiller [Udfyldes nationalt] [Se Bilag I - Udfyldes nationalt] {Navn og adresse} <{tlf.}> <{fax}> <{e-mail}>
English: Abdominal pain, diarrhoea, nausea, vomiting
Danish: Abdominale smerter, diarré, kvalme, opkastning
English: <Aminocaproic acid-containing medicinal products> [If applicable] < can be administered [either orally or] intravenously, and> is indicated for the treatment and prevention of blood loss due to excessive bleeding in the following cases:
Danish: <Lægemidler, der indeholder aminocapronsyre> [Hvis relevant] <kan gives [enten gennem munden eller] som drop i en vene (intravenøst) og> er beregnet til behandling og forebyggelse af blodtab, der skyldes kraftig blødning i følgende tilfælde:
English: The administration of aminocaproic acid should be discontinued if an increase in CPK is observed.
Danish: Administration af aminocapronsyre skal seponeres, hvis der ses en stigning i CK.
English: Intravenous route: <Aminocaproic acid-containing medicinal products> should be administered in slow intravenous injection with glycated serum, glucosaline or dextrose.
Danish: Intravenøs administration: <Lægemidler, der indeholder aminocapronsyre> skal administreres som langsom, intravenøs injektion med glykeret serum, glucose/natriumchlorid eller glucose.
English: • problems with bleeding or clotting,
Danish: • problemer med blødning eller størkning af blodet
English: Take this leaflet with you.
Danish: Medbring denne indlægsseddel.
English: Fertility, pregnancy and breast feeding
Danish: Fertilitet, graviditet og amning
English: Posology [If applicable] <Aminocaproic acid-containing medicinal products> can be administered either orally or intravenously.>
Danish: Dosering [Hvis relevant] <Lægemidler, der indeholder aminocapronsyre> kan enten administreres oralt eller intravenøst.>
English: In case of dizziness or drowsiness, driving vehicles and using machines is not recommended.
Danish: I tilfælde af svimmelhed eller søvnighed skal patienten undlade at føre motorkøretøj og betjene maskiner.
English: • significant bleeding induced by thrombolytic drugs;
Danish: • kraftig blødning fremkaldt af blodpropopløsende (trombolytiske) lægemidler
English: • Talk to your doctor before you are given X:If you have poor kidney function.
Danish: • Kontakt lægen, før du bruger [særnavn]: Hvis dine nyrer ikke fungerer ordentligt.
English: Annex III Summary of Product Characteristics and Package Leaflet
Danish: Bilag III Produktresumé og indlægsseddel
English: • dizziness, ringing or buzzing in ears,
Danish: • svimmelhed, ringen eller susen for ørerne
English: 6.6 Special precautions for disposal <and other handling> [To be completed nationally]
Danish: 6.6 Regler for bortskaffelse <og anden håndtering> [Udfyldes nationalt]
English: An adjustment of the dose in patients with impaired renal function should be made.
Danish: Dosis skal justeres hos patienter med nedsat nyrefunktion.
English: Aminocaproic acid is not recommended during pregnancy.
Danish: Aminocapronsyre bør ikke anvendes under graviditet.
English: If you have any further questions, ask your doctor.
Danish: Er du i tvivl, så spørg lægen.
English: Fibrinolysis inhibition by aminocaproic acid could theoretically result in clotting or thrombosis.
Danish: Aminocapronsyre-induceret fibrinolysehæmning kan teoretisk resultere i koagulation eller trombose.
English: In patients with haemorrhage in the upper urinary tract, the administration of aminocaproic acid has produced intrarenal obstruction in the form of glomerular capillary thrombosis or clots in the renal pelvis or ureters.
Danish: Administration af aminocapronsyre til patienter med blødning i de øvre urinveje har medført intrarenal obstruktion i form af glomerulus-kapillær trombose eller koagler i nyrebækken eller ureter.
English: Aminocaproic acid should not be used when there is evidence of an active intravascular clotting process (see section 4.4).
Danish: Aminocapronsyre må ikke anvendes, hvis der er tegn på aktiv, intravaskulær koagulation (se pkt.
English: Necrotic alterations to the heart and liver were found in the post-mortem examination.
Danish: Der blev fundet nekrotiske forandringer i hjerte og lever ved obduktionen.
English: Haemorrhages associated with thrombocytopenia, thrombopenic purpura, leukaemia.
Danish: Blødning forbundet med trombocytopeni, trombocytopenisk purpura, leukæmi.
English: Agranulocytosis, clotting disorders
Danish: Agranulocytose, koagulationsforstyrrelser
English: Intravenous route: The desired blood level is reached with an initial dose of 4 to 5 g by slow intravenous infusion (over one hour), followed by a continuous infusion of 1 g/hour.
Danish: Intravenøs administration: Den ønskede blodkoncentration opnås med en begyndelsesdosis på 4-5 g som langsom, intravenøs infusion (over en time) efterfulgt af kontinuerlig infusion af 1 g/time.
English: In no case should <Aminocaproic acid-containing medicinal products> be administered intramuscularly, as it is a highly hypertonic solution.
Danish: <Lægemidler, der indeholder aminocapronsyre> må under ingen omstændigheder administreres intramuskulært, da det er en stærkt hypertonisk opløsning.
English: Headache, malaise; injection site reactions, pain and necrosis
Danish: Hovedpine, utilpashed, reaktioner på injektionsstedet, smerter og nekrose
English: Allergic and anaphylactoid reactions, anaphylaxis
Danish: Allergiske og anafylaktoide reaktioner, anafylaksi
English: Intense menstruations, menorrhagia and haemorrhagic metropathies.
Danish: Kraftige menstruationer, menoragi og hæmoragisk metropati.
English: Muscle weakness, myalgia
Danish: Muskelsvækkelse, myalgi
English: Women of childbearing potential Aminocaproic acid is not recommended in women of childbearing potential not using contraception.
Danish: Kvinder i den fertile alder Aminocapronsyre bør ikke anvendes til kvinder i den fertile alder, som ikke anvender antikonception.
English: [If applicable] <[Oral route: Aminocaproic acid may be given by mouth in an initial dose of 4 to 5 g, followed by 1 to 1.25 g every hour.
Danish: [Hvis relevant] <[Oral administration: Aminocapronsyre kan gives oralt med en begyndelsesdosis på 4-5 g efterfulgt af 1-1,25 g hver time.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally] PHARMACEUTICAL FORM [To be completed nationally]
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Udfyldes nationalt]
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) [Udfyldes nationalt]
English: • bleeding associated with thrombocytopenia (low platelets), thrombocytopenic purpura (bleeding disorder that affects the small vessels) or leukaemia;
Danish: • blødning i forbindelse med nedsat antal blodplader (trombocytopeni), blødningsforstyrrelse, der påvirker de små blodkar (trombocytopenisk purpura) eller blodkræft (leukæmi)
English: In oral administration, the contents of the vial can be taken directly or mixed with a little sugar water, broth, milk, etc.
Danish: Hvis lægemidlet tages gennem munden, kan ampullens indhold drikkes direkte eller blandes med lidt sukkervand, bouillon, mælk el. lign.
English: Common (affects between 1 and 10 in 100 patients):
Danish: Almindelige (påvirker mellem 1 og 10 ud af 100 patienter):
English: 6.4 Special precautions for storage [To be completed nationally]
Danish: 6.4 Særlige opbevaringsforhold [Udfyldes nationalt]
English: • slow heart beat,
Danish: • langsom hjerterytme
English: NAME OF THE MEDICINAL PRODUCT <Aminocaproic acid containing medicinal products> [See Annex I - To be completed nationally]
Danish: LÆGEMIDLETS NAVN <Lægemidler, der indeholder aminocapronsyre> [Se Bilag I - Udfyldes nationalt]
English: Clinical presentation can range from mild myalgia with weakness and fatigue to severe proximal myopathy with rhabdomyolysis, myoglobinuria and acute renal failure Muscle enzymes, especially creatine phosphokinase (CPK), are elevated.
Danish: Klinisk præsentation kan variere fra let myalgi med svækkelse og træthed til svær proksimal myopati med rabdomyolyse, myoglobinuri og akut nyresvigt.
English: Serious cases of myopathy and rhabdomyolysis have been reported; these are generally reversible of discontinuation of treatment but CPK must be monitored in patients undergoing prolonged treatment and treatment stopped if any elevation in CPK occurs.
Danish: Disse er generelt reversible efter seponering af behandlingen, men CK skal monitoreres hos patienter i langvarig behandling, og behandlingen skal seponeres, hvis der forekommer en stigning i CK.
English: Pulmonary embolism
Danish: Lungeemboli
English: Summary of the safety profile
Danish: Bivirkninger a. Oversigt over sikkerhedsprofilen
English: If in doubt, see your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: [If applicable:] <For oral administration: 100 mg/kg or 3 g/m2 during the first hour, then 33.3 mg/kg per hour or 1 g/m2 per hour (maximum 18 g/m2 (600 mg/kg) in 24 hours)>
Danish: [Hvis relevant] <Oral administration: 100 mg/kg eller 3 g/m2 i løbet af den første time, derefter 33,3 mg/kg pr. time eller 1 g/m2 pr. time (højst 18 g/m2 (600 mg/kg) i løbet af 24 timer)>
English: For intravenous administration: 100 mg/kg or 3 g/m2 by slow intravenous infusion during the first hour, followed by continuous infusion at the rate of 33.3 mg/kg per hour or 1 g/m2 per hour.
Danish: Intravenøs administration: 100 mg/kg eller 3 g/m2 som langsom, intravenøs infusion i løbet af den første time efterfulgt af kontinuerlig infusion af 33,3 mg/kg pr. time eller 1 g/m2 pr. time.
English: • postsurgical haemorrhages in urology (bladder and prostate surgery), gynaecology (surgery of the cervix), obstetrics (post-partum and post-abortion haemorrhage), cardiac surgery, gastroenterology, and odontostomatology (dental extractions in haemophiliacs and patients who are receiving anticoagulant therapy);
Danish: • blødning efter operation i blære og blærehalskirtel (prostata), operation i livmoderhalsen, efter fødsel eller abort, hjerteoperation, sygdomme i mave og tarme samt efter tandudtrækninger hos blødere og hos patienter, som får blodfortyndende lægemidler (antikoagulantia)
English: The administration of <Aminocaproic acid-containing medicinal products> with the following medicines is not recommended:
Danish: Det anbefales ikke at bruge <lægemidler, der indeholder aminocapronsyre> sammen med følgende lægemidler:
English: The most commonly reported adverse reactions during treatment are dizziness, hypotension and headache; hypotension is more likely to occur with rapid infusion.
Danish: De hyppigst rapporterede bivirkninger er svimmelhed, hypotension og hovedpine.
English: Be aware that you may experience dizziness or disturbed vision during treatment and should not drive or operate machines if affected.
Danish: Vær opmærksom på, at du kan føle dig svimmel eller få synsforstyrrelser under behandlingen.
English: WHAT Aminocaproic acid containing medicinal product IS AND WHAT IT IS USED FOR <Aminocaproic acid-containing medicinal products>belongs to a group of medicines called antifibrinolytics, i.e. drugs to prevent blood loss (haemorrhage).
Danish: VIRKNING OG ANVENDELSE <Lægemidler, der indeholder aminocapronsyre> tilhører en gruppe lægemidler, der hedder antifibrinolytika.
English: Thrombophlebitis
Danish: Tromboflebitis
English: Uncommon (affects between 1 and 100 in 1,000 patients):
Danish: Ikke almindelige (påvirker mellem 1 og 100 ud af 1.000 patienter):
English: [If applicable:] <For oral administration: an initial dose of 4 to 5 g will be administered, followed by 1 to 1.25 g per hour.
Danish: [Hvis relevant:] <Indgivelse gennem munden: Der gives en begyndelsesdosis på 4-5 g efterfulgt af 1-1,25 g pr. time.
English: However, there is no clear evidence that the administration of aminocaproic acid has been responsible for the few cases described of intravascular clotting after the treatment.
Danish: Der er imidlertid ikke klar evidens for, at de få beskrevne tilfælde af intravaskulær koagulation efter behandlingen skyldes administration af aminocapronsyre.
English: For intravenous administration: an initial dose of 4 to 5 g will be administered by slow intravenous infusion (one hour) followed by a continuous infusion of 1 g per hour.
Danish: Indgivelse gennem drop (intravenøst): Der gives en begyndelsesdosis på 4-5 g som langsom intravenøs infusion (én time) efterfulgt af 1 g pr. time som vedvarende infusion.
English: Skeletal muscle effects
Danish: Virkning på skeletmuskler
English: If you forget to use <Aminocaproic acid-containing medicinal products>
Danish: Hvis du har glemt at tage <lægemidler, der indeholder aminocapronsyre>
English: Thrombogenic effect
Danish: Trombogen effekt
English: • dry ejaculation.
Danish: • væskeansamling (ødem).
English: <Aminocaproic acid-containing medicinal products> is not recommended during pregnancy..
Danish: Det anbefales ikke at bruge <lægemidler, der indeholder aminocapronsyre> under graviditet.
English: BUN increased, Nephritic colics and kidney function disorders
Danish: Nyresvigt, forhøjet blodurea-nitrogen nyrekolik og nyrefunktionslidel ser
English: [See Annex I - To be completed nationally] This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Denne indlæggelsesseddel blev senest ændret i <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}>.
English: Thrombosis
Danish: Trombose
English: Rare (affects between 1 and 10 in 10,000 patients): • pain in the arms, legs or lower back, especially pain in the calves or heels upon exertion,
Danish: • smerter i armene, benene eller lænden, især smerter i lægmusklerne eller hælene efter anstrengelse
English: Do not use <Aminocaproic acid-containing medicinal products>
Danish: Brug ikke <lægemidler, der indeholder aminocapronsyre>,
English: • a lumpy skin rash or ‘hives' anywhere on your body
Danish: • klumpet hududslæt eller nældefeber (kan optræde overalt på kroppen)
English: Acute myopathy, rhabdomyolysis
Danish: Akut myopati, rabdomyolyse
English: <Aminocaproic acid-containing medicinal products> should not be administered intramuscularly.
Danish: <Lægemidler, der indeholder aminocapronsyre> må ikke injiceres i musklerne.
English: • sudden shortness of breath or difficulty in breathing, sudden coughing for no apparent reason, chest pain and pain on breathing (as these may suggest a blood clot in the lungs),
Danish: smerter i brystet og smerter ved vejrtrækning (dette kan være tegn på en blodprop i lungerne)
English: Haemorrhage of the upper urinary tract
Danish: Blødning i de øvre urinveje
English: A more moderate dose of aminocaproic acid is indicated in patients with kidney failure, together with closer monitoring.
Danish: Nedsat nyrefunktion Dosisjustering samt nøjere overvågning er indiceret til patienter med nyresvigt.
English: • odonto-stomatology (dental extractions in haemophiliacs, patients undergoing anticoagulant therapy) Life-threatening haemorrhages induced by thrombolytics (streptokinase, etc.).
Danish: • odontostomatologi (tandekstraktion hos patienter med hæmofili og patienter i antikoagulationsbehandling).
English: 6.1 List of excipients [To be completed nationally]
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer [Udfyldes nationalt]
English: • decreased vision, watery eyes, • muscular inflammation.
Danish: • muskelinflammation (irritation i muskelvævet).
English: • If you get any side effects talk to your doctor or pharmacist.
Danish: • Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger,
English: SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
Danish: PRODUKTRESUMÉ OG INDLÆGSSEDDEL
English: • discomfort
Danish: • utilpashed
English: Dizziness
Danish: Ødem
English: What <Aminocaproic acid containing medicinal product> contains [To be completed nationally]
Danish: Pakningsstørrelser og yderligere oplysninger <Lægemidler, der indeholder aminocapronsyre> indeholder: [Udfyldes nationalt]
English: 6.3 Shelf life [To be completed nationally]
Danish: 6.3 Opbevaringstid [Udfyldes nationalt]
English: Reduced vision, watery eyes
Danish: Nedsat syn, tåreflåd
English: HOW TO USE <Aminocaproic acid-containing medicinal products>
Danish: SÅDAN SKAL DU BRUGE <lægemidler, der indeholder aminocapronsyre>
English: Maculopapular erythema
Danish: Makulopapuløst erytem
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicine, even those obtained without a prescription, homeopathic, herbal and other healthrelated products, as it may be necessary to stop the treatment or adjust the dose of one of them.
Danish: Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: BEFORE YOU USE <Aminocaproic acid-containing medicinal products>
Danish: Det skal du vide, før du begynder at bruge <lægemidler, der indeholder aminocapronsyre> Sådan skal du bruge <lægemidler, der indeholder aminocapronsyre> Bivirkninger
English: • stroke
Danish: • hudkløe
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: b. Skema over bivirkninger