natgillin/translations-raw huggingface dataset:
Konfusion, krampeanfald, delirium hallucinationer, intrakraniel hypertension, apopleksi, synkope 
Confusion, seizures, delirium, hallucinations, intracranial hypertension, stroke, syncope
• blødning i de nedre urinveje, der ikke skyldes operation (f.eks. på grund af blærebetændelse) 
• bleeding from the lower urinary tract not caused by surgery (e.g. due to inflammation of the bladder);
Du kan også få et nedsat antal hvide blodlegemer, hvilket kan øge risikoen for infektion, men det er ikke almindeligt. 
You may also uncommonly experience a decrease in white blood cells, which can increase the risk of infection.
Forhøjet CK, myositis 
Elevated CPK, myositis
En patient med tidligere tilfælde af hjernetumor og krampeanfald fik krampeanfald efter at have fået en bolusinjektion på 8 g aminocapronsyre. 
One patient with a history of brain tumour and seizures presented seizures after receiving a bolus injection of 8 g of aminocaproic acid.
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. 
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.
Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis. 
Do not use a double dose to make up for a forgotten dose but continue to use the vials as usual.
Ældre patienter Dosisreduktion er kun nødvendigt i tilfælde af nedsat nyrefunktion. 
Elderly patients Dose reductions are not necessary other than in cases of kidney failure.
<Lægemidler, der indeholder aminocapronsyre> anvendes til at forebygge blodtab, der skyldes kraftig blødning, hos patienter i alle aldre. 
<Aminocaproic acid-containing medicinal products> is used to prevent blood loss due to excessive bleeding in patients of all ages.
Hvis langvarig behandling er nødvendig, må den maksimale dosis normalt ikke overstige 24 g i løbet af 24 timer. 
If treatment needs to be extended, the maximum dose over 24 hours should not normally exceed 24 g.
Farmakokinetiske studier viser, at den totale udskillelse af aminocapronsyre er stærkt nedsat hos patienter med akut nyresvigt. 
The pharmacokinetic studies show that total body clearance of aminocaproic acid is highly diminished in patients with acute kidney failure.
Adskillige kliniske studier viser, at aminocapronsyre ikke har nogen trombogen effekt. 
Numerous clinical studies show that aminocaproic acid has no thrombogenic effect.
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. 
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.
• blodtryksfald 
• decrease in blood pressure;
Det er observeret, at aminocapronsyre har medført teratogen virkning hos rotter. 
Aminocaproic acid has been observed to give rise to teratogenic effects in rats.
Som resultat af disse virkninger forebygger aminocapronsyre plasmins koageldestruktion og forebygger dermed fremkomst af blødninger, der skyldes for stor aktivitet af det fibrinolytiske system. 
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.
Aminocapronsyre (EACA) er indiceret til patienter i alle aldre med blødning, der skyldes lokal eller generel fibrinolyse, inklusive til postoperativ blødning ved: 
Aminocaproic acid is indicated for use in patients of all ages in haemorrhage caused by local or general fibrinolysis, including in Postsurgical haemorrhages in:
[Hvis relevant] <[Ved oral administration kan ampullens indhold drikkes rent eller blandes med lidt sukkervand, bouillon, mælk el. 
[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.]>
Leukopeni, trombocytopeni 
Leukopenia, thrombocytopenia
Meget sjældne (påvirker færre end 1 ud af 10.000 patienter): 
Very rare (affects less than 1 in 10,000 patients):
Indehaver af markedsføringstilladelsen og fremstiller [Udfyldes nationalt] [Se Bilag I - Udfyldes nationalt] {Navn og adresse} <{tlf.}> <{fax}> <{e-mail}> 
Marketing Authorisation Holder and Manufacturer [To be completed nationally] [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Abdominale smerter, diarré, kvalme, opkastning 
Abdominal pain, diarrhoea, nausea, vomiting
<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: 
<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:
Administration af aminocapronsyre skal seponeres, hvis der ses en stigning i CK. 
The administration of aminocaproic acid should be discontinued if an increase in CPK is observed.
Intravenøs administration: <Lægemidler, der indeholder aminocapronsyre> skal administreres som langsom, intravenøs injektion med glykeret serum, glucose/natriumchlorid eller glucose. 
Intravenous route: <Aminocaproic acid-containing medicinal products> should be administered in slow intravenous injection with glycated serum, glucosaline or dextrose.
• problemer med blødning eller størkning af blodet 
• problems with bleeding or clotting,
Medbring denne indlægsseddel. 
Take this leaflet with you.
Fertilitet, graviditet og amning 
Fertility, pregnancy and breast feeding
Dosering [Hvis relevant] <Lægemidler, der indeholder aminocapronsyre> kan enten administreres oralt eller intravenøst.> 
Posology [If applicable] <Aminocaproic acid-containing medicinal products> can be administered either orally or intravenously.>
I tilfælde af svimmelhed eller søvnighed skal patienten undlade at føre motorkøretøj og betjene maskiner. 
In case of dizziness or drowsiness, driving vehicles and using machines is not recommended.
• kraftig blødning fremkaldt af blodpropopløsende (trombolytiske) lægemidler 
• significant bleeding induced by thrombolytic drugs;
• Kontakt lægen, før du bruger [særnavn]: Hvis dine nyrer ikke fungerer ordentligt. 
• Talk to your doctor before you are given X:If you have poor kidney function.
Bilag III Produktresumé og indlægsseddel 
Annex III Summary of Product Characteristics and Package Leaflet
• svimmelhed, ringen eller susen for ørerne 
• dizziness, ringing or buzzing in ears,
6.6 Regler for bortskaffelse <og anden håndtering> [Udfyldes nationalt] 
6.6 Special precautions for disposal <and other handling> [To be completed nationally]
Dosis skal justeres hos patienter med nedsat nyrefunktion. 
An adjustment of the dose in patients with impaired renal function should be made.
Aminocapronsyre bør ikke anvendes under graviditet. 
Aminocaproic acid is not recommended during pregnancy.
Er du i tvivl, så spørg lægen. 
If you have any further questions, ask your doctor.
Aminocapronsyre-induceret fibrinolysehæmning kan teoretisk resultere i koagulation eller trombose. 
Fibrinolysis inhibition by aminocaproic acid could theoretically result in clotting or thrombosis.
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. 
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.
Aminocapronsyre må ikke anvendes, hvis der er tegn på aktiv, intravaskulær koagulation (se pkt. 
Aminocaproic acid should not be used when there is evidence of an active intravascular clotting process (see section 4.4).
Der blev fundet nekrotiske forandringer i hjerte og lever ved obduktionen. 
Necrotic alterations to the heart and liver were found in the post-mortem examination.
Blødning forbundet med trombocytopeni, trombocytopenisk purpura, leukæmi. 
Haemorrhages associated with thrombocytopenia, thrombopenic purpura, leukaemia.
Agranulocytose, koagulationsforstyrrelser 
Agranulocytosis, clotting disorders
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. 
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.
<Lægemidler, der indeholder aminocapronsyre> må under ingen omstændigheder administreres intramuskulært, da det er en stærkt hypertonisk opløsning. 
In no case should <Aminocaproic acid-containing medicinal products> be administered intramuscularly, as it is a highly hypertonic solution.
Hovedpine, utilpashed, reaktioner på injektionsstedet, smerter og nekrose 
Headache, malaise; injection site reactions, pain and necrosis
Allergiske og anafylaktoide reaktioner, anafylaksi 
Allergic and anaphylactoid reactions, anaphylaxis
Kraftige menstruationer, menoragi og hæmoragisk metropati. 
Intense menstruations, menorrhagia and haemorrhagic metropathies.
Muskelsvækkelse, myalgi 
Muscle weakness, myalgia
Kvinder i den fertile alder Aminocapronsyre bør ikke anvendes til kvinder i den fertile alder, som ikke anvender antikonception. 
Women of childbearing potential Aminocaproic acid is not recommended in women of childbearing potential not using contraception.
[Hvis relevant] <[Oral administration: Aminocapronsyre kan gives oralt med en begyndelsesdosis på 4-5 g efterfulgt af 1-1,25 g hver time. 
[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.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Udfyldes nationalt] 
QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally] PHARMACEUTICAL FORM [To be completed nationally]
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) [Udfyldes nationalt] 
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally]
• blødning i forbindelse med nedsat antal blodplader (trombocytopeni), blødningsforstyrrelse, der påvirker de små blodkar (trombocytopenisk purpura) eller blodkræft (leukæmi) 
• bleeding associated with thrombocytopenia (low platelets), thrombocytopenic purpura (bleeding disorder that affects the small vessels) or leukaemia;
Hvis lægemidlet tages gennem munden, kan ampullens indhold drikkes direkte eller blandes med lidt sukkervand, bouillon, mælk el. lign. 
In oral administration, the contents of the vial can be taken directly or mixed with a little sugar water, broth, milk, etc.
Almindelige (påvirker mellem 1 og 10 ud af 100 patienter): 
Common (affects between 1 and 10 in 100 patients):
6.4 Særlige opbevaringsforhold [Udfyldes nationalt] 
6.4 Special precautions for storage [To be completed nationally]
• langsom hjerterytme 
• slow heart beat,
LÆGEMIDLETS NAVN <Lægemidler, der indeholder aminocapronsyre> [Se Bilag I - Udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT <Aminocaproic acid containing medicinal products> [See Annex I - To be completed nationally]
Klinisk præsentation kan variere fra let myalgi med svækkelse og træthed til svær proksimal myopati med rabdomyolyse, myoglobinuri og akut nyresvigt. 
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.
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. 
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.
Lungeemboli 
Pulmonary embolism
Bivirkninger a. Oversigt over sikkerhedsprofilen 
Summary of the safety profile
Er du i tvivl, så spørg lægen eller på apoteket. 
If in doubt, see your doctor or pharmacist.
[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)> 
[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)>
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. 
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.
• 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) 
• 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);
Det anbefales ikke at bruge <lægemidler, der indeholder aminocapronsyre> sammen med følgende lægemidler: 
The administration of <Aminocaproic acid-containing medicinal products> with the following medicines is not recommended:
De hyppigst rapporterede bivirkninger er svimmelhed, hypotension og hovedpine. 
The most commonly reported adverse reactions during treatment are dizziness, hypotension and headache; hypotension is more likely to occur with rapid infusion.
Vær opmærksom på, at du kan føle dig svimmel eller få synsforstyrrelser under behandlingen. 
Be aware that you may experience dizziness or disturbed vision during treatment and should not drive or operate machines if affected.
VIRKNING OG ANVENDELSE <Lægemidler, der indeholder aminocapronsyre> tilhører en gruppe lægemidler, der hedder antifibrinolytika. 
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).
Tromboflebitis 
Thrombophlebitis
Ikke almindelige (påvirker mellem 1 og 100 ud af 1.000 patienter): 
Uncommon (affects between 1 and 100 in 1,000 patients):
[Hvis relevant:] <Indgivelse gennem munden: Der gives en begyndelsesdosis på 4-5 g efterfulgt af 1-1,25 g pr. time. 
[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.
Der er imidlertid ikke klar evidens for, at de få beskrevne tilfælde af intravaskulær koagulation efter behandlingen skyldes administration af aminocapronsyre. 
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.
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. 
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.
Virkning på skeletmuskler 
Skeletal muscle effects
Hvis du har glemt at tage <lægemidler, der indeholder aminocapronsyre> 
If you forget to use <Aminocaproic acid-containing medicinal products>
Trombogen effekt 
Thrombogenic effect
• væskeansamling (ødem). 
• dry ejaculation.
Det anbefales ikke at bruge <lægemidler, der indeholder aminocapronsyre> under graviditet. 
<Aminocaproic acid-containing medicinal products> is not recommended during pregnancy..
Nyresvigt, forhøjet blodurea-nitrogen nyrekolik og nyrefunktionslidel ser 
BUN increased, Nephritic colics and kidney function disorders
Denne indlæggelsesseddel blev senest ændret i <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}>. 
[See Annex I - To be completed nationally] This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Trombose 
Thrombosis
• smerter i armene, benene eller lænden, især smerter i lægmusklerne eller hælene efter anstrengelse 
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,
Brug ikke <lægemidler, der indeholder aminocapronsyre>, 
Do not use <Aminocaproic acid-containing medicinal products>
• klumpet hududslæt eller nældefeber (kan optræde overalt på kroppen) 
• a lumpy skin rash or ‘hives' anywhere on your body
Akut myopati, rabdomyolyse 
Acute myopathy, rhabdomyolysis
<Lægemidler, der indeholder aminocapronsyre> må ikke injiceres i musklerne. 
<Aminocaproic acid-containing medicinal products> should not be administered intramuscularly.
smerter i brystet og smerter ved vejrtrækning (dette kan være tegn på en blodprop i lungerne) 
• 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),
Blødning i de øvre urinveje 
Haemorrhage of the upper urinary tract
Nedsat nyrefunktion Dosisjustering samt nøjere overvågning er indiceret til patienter med nyresvigt. 
A more moderate dose of aminocaproic acid is indicated in patients with kidney failure, together with closer monitoring.
• odontostomatologi (tandekstraktion hos patienter med hæmofili og patienter i antikoagulationsbehandling). 
• odonto-stomatology (dental extractions in haemophiliacs, patients undergoing anticoagulant therapy) Life-threatening haemorrhages induced by thrombolytics (streptokinase, etc.).
FARMACEUTISKE OPLYSNINGER 6.1 Fortegnelse over hjælpestoffer [Udfyldes nationalt] 
6.1 List of excipients [To be completed nationally]
• muskelinflammation (irritation i muskelvævet). 
• decreased vision, watery eyes, • muscular inflammation.
• Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, 
• If you get any side effects talk to your doctor or pharmacist.
PRODUKTRESUMÉ OG INDLÆGSSEDDEL 
SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
• utilpashed 
• discomfort
Ødem 
Dizziness
Pakningsstørrelser og yderligere oplysninger <Lægemidler, der indeholder aminocapronsyre> indeholder: [Udfyldes nationalt] 
What <Aminocaproic acid containing medicinal product> contains [To be completed nationally]
6.3 Opbevaringstid [Udfyldes nationalt] 
6.3 Shelf life [To be completed nationally]
Nedsat syn, tåreflåd 
Reduced vision, watery eyes
SÅDAN SKAL DU BRUGE <lægemidler, der indeholder aminocapronsyre> 
HOW TO USE <Aminocaproic acid-containing medicinal products>
Makulopapuløst erytem 
Maculopapular erythema
Tal med lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel. 
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.
Det skal du vide, før du begynder at bruge <lægemidler, der indeholder aminocapronsyre> Sådan skal du bruge <lægemidler, der indeholder aminocapronsyre> Bivirkninger 
BEFORE YOU USE <Aminocaproic acid-containing medicinal products>
• hudkløe 
• stroke
b. Skema over bivirkninger 
SUMMARY OF PRODUCT CHARACTERISTICS
• smerter i eller strammende følelse omkring brystet 
• chest pain or chest tightness
• besvimelse. 
• fainting.
Retrograd ejakulation 
Dry ejaculation
Administration 
Method of administration
• muskelsvækkelse, muskelsmerter 
Musculoskeletal and connective tissue disorders
• kvalme 
• convulsions
• pludselig hvæsende vejrtrækning 
• difficult or laboured breathing,
• uklar bevidsthed (delirium) 
• delirium
• tilstoppet næse 
• nasal congestion
• nyresvigt 
• kidney failure
90 (3 x 30) tabletter 
Bottle (HDPE) 90 (3 x 30) tablets
Lægemiddelform Administration Emballage 
Pharmaceutical form
30 tabletter 
Bottle (HDPE) 30 tablets
Proppen må ikke gennemstikkes mere end 20 gange. 
The stopper should not be punctured more than 20 times.
Metabolismen hos heste er ikke undersøgt. 
The metabolism in horses has not been investigated.
Det aktive stof i Meloxidolor er et tilladt stof, der er beskrevet i tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010: 
The active substance in Meloxidolor is an allowed substance as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Dato for første tilladelse: 22/04/2013 Dato for seneste fornyelse af markedsføringstilladelse: 20/04/2018 
Date of first authorisation: 22/04/2013 Date of last renewal: 20/04/2018
Undgå at indføre kontaminanter under brugen. 
Avoid introduction of contamination during use.
21 % af den genfundne dosis elimineres i urin (2 % som uændret meloxicam, 19 % som metabolitter) og 79 % i fæces (49 % som uændret meloxicam, 30 % som metabolitter). 
21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites).
Hjælpestofferne anført under punkt 6.1 i SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommisionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel. 
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Tilbageholdelsestid: Kvæg: 
Withdrawal period: Cattle:
Forudgående behandling med antiinflammatoriske substanser kan resultere i yderligere eller forstærkede bivirkninger, og derfor bør der indlægges en periode uden behandling med sådanne veterinære lægemidler på mindst 24 timer, inden behandlingen påbegyndes. 
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment.
Indehaver af markedsføringstilladelsen: Le Vet Beheer B.V. 
Marketing authorisation holder: Le Vet Beheer B.V.
Meloxidolor alene vil ikke give tilstrækkelig smertelindring under afhorning. 
Meloxidolor alone will not provide adequate pain relief during the dehorning procedure.