FrancophonIA/ELRC3.0 huggingface dataset:
English: An association between aprotinin use and increased mortality has been reported in some nonrandomized observational studies (eg, Mangano 2007, Schneeweiss 2008, Olenchock 2008, Shaw 2008) while other non-randomized studies have not reported such an association (eg, Karkouti 2006, Mangano 2006, Coleman 2007, Pagano 2008, Ngaage 2008, Karkouti, 2009).
Danish: Der er set en forbindelse mellem brug af aprotinin og øget mortalitet i nogle ikke-randomiserede observationsstudier (f.eks. Mangano 2007, Schneeweiss 2008, Olenchock 2008, Shaw 2008), medens der ikke er set en sådan forbindelse i andre ikke-randomiserede studier (f.eks. Karkouti 2006, Mangano 2006, Coleman 2007, Pagano 2008, Ngaage 2008, Karkouti 2009).
English: Aprotinin gave a negative mutagenic response in the Salmonella/microsome and B. subtilis DNA damage system.
Danish: Mutagent potentiale Aprotinin gav et negativt mutagent respons i Salmonella/mikrosom-testen og B. subtilis DNA-skadesystemet.
English: Aprotinin must be given only to patients in the supine position and must be given slowly (maximum 5 - 10 ml/min) as an intravenous injection or a short infusion.
Danish: Aprotinin må kun gives til patienter, der ligger ned, og skal indgives langsomt (maksimum 5-10 ml/min) som en intravenøs injektion eller en kortvarig infusion.
English: After the uneventful administration of the 1 ml test dose, the therapeutic dose may be given.
Danish: Hvis der ikke kommer reaktioner efter administration af 1 ml testdosen, kan den terapeutiske dosis gives.
English: Therefore, the partial thromboplastin time (PTT) should not be used to maintain adequate anticoagulation with heparin.
Danish: Derfor bør partiel tromboplastintid (PTT) ikke anvendes til at opretholde tilstrækkelig antikoagulation med heparin.
English: It is recommended that your doctor/surgeon should, in addition to <Aprotinin-containing medicinal product>, administer heparin (a medicine used to prevent blood clots) before and during the operation.
Danish: Det anbefales, at din læge/kirurg - ud over <lægemiddel, der indeholder aprotinin> - også ordinerer heparin (medicin til forebyggelse af blodpropper) før og under operationen.
English: Although allergic reactions are rare in patients receiving <Aprotinin-containing medicinal product> for the first time, patients who are given <Aprotinin-containing medicinal product> more than once may have an increased chance of an allergic reaction.
Danish: Allergiske reaktioner er sjældne hos patienter, der får <lægemiddel, der indeholder aprotinin> for første gang, men patienter, der får <lægemiddel, der indeholder aprotinin> mere end én gang, kan have en øget risiko for at få en allergisk reaktion.
English: However, since aprotinin is not bioavailable after oral administration, any drug contained in the milk is not expected to have a systemic effect on the breast-feed child.
Danish: Da aprotinin ikke er biotilgængeligt efter oral indgift, forventes det ikke, at lægemiddel i mælken har en systemisk virkning på det ammede barn.
English: Any residual solution should not be kept for later use.
Danish: Eventuel resterende opløsning må ikke gemmes til senere brug.
English: Even when a second exposure to aprotinin has been tolerated without symptoms, a subsequent administration may result in severe allergic reactions or anaphylactic shock with, in very rare cases, fatal outcome.
Danish: Selv når den anden eksponering for aprotinin har været tålt uden symptomer, kan en efterfølgende administration resultere i alvorlige allergiske reaktioner eller anafylaktisk shock, i sjældne tilfælde med dødelig udgang.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Denne indlægsseddel blev senest revideret {måned ÅÅÅÅ}.
English: The aprotinin molecule is metabolised to shorter peptides or amino acids by lysosomal activity in the kidney.
Danish: Aprotininmolekylet metaboliseres til mindre peptider eller aminosyrer ved lysosomal aktivitet i nyrerne.
English: Fertility There are no adequate and well-controlled studies addressing fertility in men or women.
Danish: Der foreligger ikke tilstrækkelige og velkontrollerede studier af påvirkning af fertiliteten hos mænd eller kvinder.
English: It has been observed that kaolin-based ACTs are not increased to the same degree by aprotinin as are diatomaceous earth-based (celite) ACTs.
Danish: Det er blevet observeret, at kaolinbaserede ACT'er ikke øges i samme grad af tilstedeværelsen af aprotinin, som ACT'er baseret på kiselalger (celit).
English: In general, you will not be given more than 700 ml of <Aprotinin-containing medicinal product> at any one time.
Danish: Normalt vil du ikke få mere end 700 ml <lægemiddel, der indeholder aprotinin> i et forløb.
English: If there are no signs of allergy, you will be given 100-200 ml <Aprotinin-containing medicinal product> over 20 to 30 minutes, followed by 25 - 50 ml per hour (max. 5 - 10 ml/min) until the end of the operation.
Danish: Hvis der ikke er tegn på allergi, vil du få 100-200 ml <lægemiddel, der indeholder aprotinin> i løbet af 20-30 minutter, efterfulgt af 25-50 ml pr. time (maksimalt 5-10 ml/min), indtil operationen er overstået.
English: A special dose adjustment is not warranted.
Danish: Speciel dosisjustering er ikke påkrævet.
English: Oliguria, acute renal failure, renal tubular necrosis
Danish: Oliguri, akut nyresvigt, renal tubulær nekrose
English: 6.6 Special precautions for disposal and other handling Parenteral drug products should be inspected visually for particulate matter and colour change prior to administration.
Danish: 6.6 Regler for destruktion og anden håndtering Parenterale lægemidler skal inspiceres visuelt for partikler og farveændring før indgift.
English: Full-Dose Aprotinin
Danish: Fuld dosis aprotinin
English: An appropriate aprotinin-specific IgG antibody test may be considered before administration of aprotinin (see section 4.3).
Danish: En passende aprotininspecifik IgG-antistoftest kan overvejes før administration af aprotinin (se pkt.
English: Owing to the risk of allergic/anaphylactic reactions, a 1 ml (10,000 KIU) test dose should be administered to all patients at least 10 minutes prior to the remainder of the dose.
Danish: På grund af risikoen for allergiske/anafylaktiske reaktioner bør der administreres en testdosis på 1 ml (10.000 KIE) til alle patienter mindst 10 minutter før resten af dosis.
English: An ACT is not a standardized coagulation test, and different formulations of the assay are affected differently by the presence of aprotinin.
Danish: ACT er ikke en standardiseret koagulationstest, og de forskellige udgaver af testen påvirkes forskelligt af aprotinin.
English: There are no adequate and well-controlled studies in pregnant women.
Danish: Der er ikke tilstrækkelige og velkontrollerede data fra anvendelse af aprotinin til gravide kvinder.
English: The most serious adverse reaction was myocardial infarction.
Danish: Den alvorligste bivirkning var myokardieinfarkt.
English: If allergic reactions occur during injection or infusion, administration should be stopped immediately.
Danish: Hvis der forekommer allergiske reaktioner under injektionen/infusionen, skal indgiften straks stoppes.
English: <Aprotinin-containing medicinal product> can help to reduce the amount of blood loss you have during and after heart surgery.
Danish: <Lægemidler, der indeholder aprotinin> kan hjælpe til med at nedsætte det blodtab, du har under og efter en hjerteoperation.
English: Heparin levels during bypass should not be allowed to drop below 2.7 U/ml (2.0 mg/kg) or below the level indicated by heparin dose-response testing performed prior to administration of aprotinin.
Danish: Heparin-niveauerne under bypass bør ikke falde til under 2,7 IE/ml (2,0 mg/kg) eller under det niveau, der er fundet ved dosisresponstesten af heparin, der blev foretaget før indgift af aprotinin.
English: Standard emergency treatment may be required, i.e. adrenaline/epinephrine, volume substitution and corticosteroids.
Danish: Standardbehandling kan være påkrævet som f.eks. adrenalin, volumensubstitution og kortikosteroider.
English: Studies in patients with renal impairment revealed no clinically significant pharmacokinetic alterations or obvious side effects.
Danish: Studier hos patienter med nedsat nyrefunktion viste ingen klinisk signifikante farmakokinetiske forandringer eller tydelige bivirkninger.
English: You will be monitored carefully for any allergic reaction to the medicine and your doctor/surgeon will treat any symptoms you may experience.
Danish: Du vil blive overvåget omhyggeligt for at se, om du har nogen allergiske reaktioner over for lægemidlet, og din læge/kirurg vil behandle dine eventuelle symptomer.
English: No pharmacokinetic studies are available in patients with terminal renal insufficiency.
Danish: Der findes ingen farmakokinetiske studier hos patienter med terminal nyreinsufficiens.
English: A loading dose of 1 - 2 million KIU is administered as a slow intravenous injection or infusion over 20 - 30 minutes after induction of anaesthesia and prior to sternotomy.
Danish: En støddosis på 1-2 mio. KIE gives som langsom intravenøs injektion eller infusion over 20-30 minutter efter induktion af anæstesi og før sternotomi.
English: By forming reversible stoichiometric enzyme-inhibitor complexes, aprotinin acts as an inhibitor of human trypsin, plasmin, plasma kallikrein and tissue kallikrein, thus inhibiting fibrinolysis.
Danish: Ved at danne reversible støkiometriske enzymhæmmerkomplekser virker aprotinin som en hæmmer af humant trypsin, plasmin, plasmakallikrein og vævskallikrein og hæmmer derved fibrinolyse.
English: Protamine titration, a method that is not affected by aprotinin, can be used to measure heparin levels.
Danish: Protamin-titrering, der er en metode, der ikke påvirkes af aprotinin, kan anvendes til at måle heparinniveauerne.
English: Although the majority of cases of anaphylaxis occur upon re-exposure within the first 12 months, there are also single case reports of anaphylaxis occurring upon re-exposure after more than 12 months.
Danish: Selvom størstedelen af anafylaksitilfældene forekommer ved reeksponering inden for de første 12 måneder, er der også enkelte rapporter om anafylaksi ved reeksponering efter mere end 12 måneder.
English: Daily doses of up to 100,000 KIU/kg did not interfere with the growth and development of the young, and doses of 200,000 KIU/kg/day were not teratogenic.
Danish: Daglige doser på op til 100.000 KIE/kg påvirkede ikke vækst eller udvikling hos de unge dyr, og doser på 200.000 KIE/kg/dag var ikke teratogene.
English: The test is further influenced by variable dilution effects and the temperature experienced during cardiopulmonary bypass.
Danish: Testen bliver yderligere påvirket af forskellige fortyndingseffekter og af temperaturen under kardiopulmonal bypass.
English: The in-hospital mortality in a pool of randomized, clinical trials is summarized in the table below:
Danish: Mortaliteten under hospitalsindlæggelse i en pool af randomiserede kliniske studier er sammenfattet i tabellen nedenfor:
English: You should specifically tell your doctor if you take: - medicines used to dissolve blood clots, such as streptokinase, urokinase, alteplase (r-tPA) - aminoglycosides (antibiotics, medicines used to treat infections)
Danish: Du skal især fortælle lægen, hvis du tager: - Medicin, der anvendes til at opløse blodpropper, som fx streptokinase, urokinase, alteplase (rtPA) - Aminoglykosider (antibiotika, medicin til behandling af infektioner)
English: Results from recent observational studies indicate that renal dysfunction could be triggered by aprotinin, particularly in patients with pre-existing renal dysfunction.
Danish: Resultaterne fra nylige observationsstudier tyder på, at renal dysfunktion kan blive udløst af aprotinin, især hos patienter med præeksisterende renal dysfunktion.
English: After receiving injections of 131I-aprotinin healthy volunteers excreted within 48 hours 25 - 40 % of the labelled substance as metabolites in the urine.
Danish: Raske forsøgspersoner, der havde fået injektioner af 131I-aprotinin, udskilte inden for 48 timer 25-40 % af den mærkede substans som metabolitter i urinen.
English: Package leaflet: Information for the patient
Danish: Indlægsseddel: Information till brugeren
English: A retrospective review suggests that the incidence of severe anaphylactic reactions to aprotinin may further increase when patients are re-exposed more than twice within 6 months.
Danish: En retrospektiv vurdering tyder på, at incidensen af alvorlige anafylaktiske reaktioner over for aprotinin kan øges yderligere, hvis patienten bliver reeksponeret mere end to gange inden for 6 måneder.
English: All patients treated with aprotinin should first receive a test dose to assess the potential for allergic reactions (see section 4.2).
Danish: Alle patienter, der skal behandles med aprotinin, bør først gives en testdosis for at vurdere risikoen for allergiske reaktioner (se pkt.
English: A H1-antagonist and a H2-antagonist may be administered 15 minutes prior to the test dose of aprotinin.
Danish: En H1-antagonist og en H2-antagonist kan administreres 15 minutter før aprotinin-testdosen.
English: Paediatric population The safety and efficacy in children below 18 years of age have not been established.
Danish: Pædiatriske patienter Aprotinins sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Animal studies did not provide any evidence of teratogenic or other embryotoxic effects of aprotinin.
Danish: Dyrestudier viste ikke tegn på teratogene eller andre embryotoksiske virkninger af aprotinin.
English: A standard loading dose of heparin, administered prior to cannulation of the heart, plus the quantity of heparin added to the prime volume of the cardiopulmonary bypass circuit, should total at least 350 IU/kg.
Danish: Den standard-støddosis af heparin, der bliver administreret før kanylering af hjertet, plus den mængde heparin, der bliver tilsat primingvolumenet i det kardiopulmonale bypass-kredsløb, bør i alt være mindst 350 IE/kg.
English: 4.9 Overdose There is no specific antidote.
Danish: Der er ikke nogen specifik antidot.
English: Allergic/anaphylactic reactions are rare in patients with no prior exposure to aprotinin.
Danish: Allergiske/anafylaktiske reaktioner er sjældne hos patienter, der ikke tidligere har været eksponeret for aprotinin.
English: A retrospective review showed that the incidence of an allergic/anaphylactic reaction following reexposure is increased when the re-exposure occurs within 6 months of the initial administration (5.0 % for re-exposure within 6 months and 0.9 % for re-exposures greater than 6 months).
Danish: En retrospektiv vurdering viste, at incidensen af en allergisk/anafylaktisk reaktion efter reeksponering er øget, hvis reeksponeringen sker inden for 6 måneder efter den initiale administration (5 % ved reeksponering inden for 6 måneder og 0,9 % ved reeksponering efter mere end 6 måneder).
English: Aprotinin is a broad spectrum protease inhibitor which has antifibrinolytic properties.
Danish: Aprotinin er en bredspektret proteinasehæmmer med antifibrinolytiske egenskaber.
English: In case of severe adverse drug reactions (like anaphylactic reaction, heart arrest, etc.) and their consecutive therapeutic measures, damage to the foetus has to be taken into account for a risk/benefit evaluation.
Danish: I tilfælde af alvorlige bivirkninger (som anafylaktiske reaktioner, hjertestop etc.) og den efterfølgende relevante behandling må skade på fosteret tages med i overvejelserne i vurderingen af fordele og risici.
English: Elevations in the partial thromboplastin time (PTT) and celite Activated Clotting Time (Celite ACT) are expected in aprotinin-treated patients during surgery, and in the hours after surgery.
Danish: Der kan forventes stigning i den partielle tromboplastintid (PTT) og celit-ACT (Activated Clotting Time) hos patienter, der bliver behandlet med aprotinin, under operationen og i timerne efter operationen.
English: There is no special dose recommendation for elderly patients or patients with poor kidney function
Danish: Der er ingen speciel dosisanbefaling til ældre patienter eller til patienter med dårlig nyrefunktion.
English: The symptoms of an allergic reaction may include: breathing difficulties reduced blood pressure itching, rash and hives feeling sick
Danish: Symptomerne på en allergisk reaktion kan omfatte: - Åndedrætsbesvær - Blodtryksfald - Kløe, udslæt og nældefeber
English: Additional heparin should be administered in a fixed-dose regimen based on patient weight and duration of cardiopulmonary bypass.
Danish: Yderligere heparin bør administreres i et fast doseringsregime baseret på patientens vægt og varigheden af kardiopulmonal bypass.
English: if you are allergic to <Aprotinin-containing medicinal product> or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for aprotinin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i pkt.
English: Laboratory monitoring of anticoagulation during cardiopulmonary bypass Aprotinin is not a heparin-sparing agent and it is important that adequate anticoagulation with heparin be maintained during aprotinin-therapy.
Danish: Laboratorieovervågning af antikoagulation under kardiopulmonal bypass Aprotinin er ikke et heparinbesparende lægemiddel, og det er vigtigt at opretholde tilstrækkelig antikoagulation med heparin under aprotinin-behandling.
English: The safety and efficacy of <Aprotinin-containing medicinal product> in children below the age of 18 years have not been established.
Danish: Børn og teenagere Sikkerhed og virkning af <lægemidler, der indholder aprotinin> til børn under 18 år er ikke klarlagt.
English: A publication by Fergusson et al 2008 analyzed data from a randomized controlled trial, Blood Conservation Using Antifibrinolytics in a Randomized Trial (BART), and reported a higher mortality rate in aprotinin-treated patients compared to those treated with tranexamic acid or aminocaproic acid.
Danish: En publikation af Fergusson et al 2008 analyserede data fra et randomiseret, kontrolleret studie, BARTstudiet (Blood Conservation Using Antifibrinolytics in a Randomized Trial), og viste en højere mortalitet hos patienter, der var blevet behandlet med aprotinin sammenlignet med patienter, der var blevet behandlet med tranexamsyre eller aminocapronsyre.
English: Your doctor/surgeon has decided that you would benefit from <Aprotinin-containing medicinal product> treatment because you are at increased risk of major blood loss since you will undergo a heart bypass operation using a circulation outside your body (heart-lung machine).
Danish: Din læge/kirurg har besluttet, at du vil have gavn af behandling med <lægemiddel indholdende aprotinin>, fordi du har øget risiko for at få et stort blodtab i forbindelse med, at du skal gennemgå en bypass-operation i hjertet, hvor din blodcirkulation styres uden for din krop af en hjertelunge-maskine.
English: This includes any side effects not listed in this leaflet.
Danish: Dette gælder også bivirkninger, som ikke er nævnt her.
English: Additional note on use with extracorporeal circulation In patients undergoing cardiopulmonary bypass with aprotinin therapy, one of the following methods is recommended to maintain adequate anticoagulation:
Danish: Supplerende bemærkning om brug ved ekstrakorporal cirkulation Hos patienter, der gennemgår kardiopulmonal bypass med aprotinin-behandling, anbefales én af følgende metoder til at opretholde tilstrækkelig antikoagulation:
English: Very rare: < 1/10,000
Danish: Meget sjælden: <1/10.000
English: The adverse reactions should be interpreted within the surgical setting.
Danish: Bivirkningerne skal fortolkes i kirurgisk sammenhæng.
English: Aprotinin should be infused using a central venous catheter.
Danish: Aprotinin bør administreres gennem et centralvenekateter.
English: Standard emergency treatment for severe allergic reactions should be readily available during treatment with <Aprotinin-containing medicinal product>.
Danish: Standardbehandling for alvorlige allergiske reaktioner skal være let tilgængelig under behandling med <lægemiddel, der indeholder aprotinin>.
English: In rats, guinea-pigs, rabbits and dogs, high doses (>150.000 KIU/kg) injected quickly caused a blood pressure reduction of varying magnitude, which rapidly subsided.
Danish: Høje doser (> 150.000 KIU/kg) injiceret hurtigt i rotter, marsvin, kaniner og hunde forårsagede en blodtryksreduktion af varierende størrelse, som hurtigt aftog.
English: Careful consideration of the balance of risks and benefits is therefore advised before administration of aprotinin to patients with pre-existing impaired renal function or those with risk factors (such as concomitant treatment with aminoglycosides).
Danish: Derfor tilrådes en nøje vurdering af fordele og risici før indgift af aprotinin til patienter med nedsat nyrefunktion eller med risikofaktorer (som f.eks. samtidig behandling med aminoglykosider).
English: Allergic reaction Anaphylactic / anaphylactoid reaction
Danish: Allergiske reaktioner Anafylaktisk/ anafylaktoid reaktion
English: Your doctor will administer aprotinin after careful consideration of the benefits and risks, and the availability of alternative treatments.
Danish: Din læge vil give dig aprotinin efter nøje at have overvejet fordele og risici samt muligheden for anden behandling.
English: In-hospital Mortality in a pool of Randomized Clinical Trials (Population: All Global CABG Patients Valid for Safety)
Danish: Mortaliteten under hospitalsindlæggelse i en pool af randomiserede kliniske studier (Population: Alle patienter globalt, som har gennemgået koronar bypass-operation (CABG), valideret for sikkerhed)
English: The test dose of aprotinin should only be administered when facilities and equipment for handling acute anaphylactic reactions are available on-site.
Danish: En aprotinin-testdosis bør kun gives, når faciliteter og udstyr til hurtig behandling af anafylaktiske reaktioner er tilgængelige på stedet.
English: Renal dysfunction could be triggered by aprotinin, particularly in patients with pre-existing renal dysfunction.
Danish: Aprotinin kan udløse renal dysfunktion, især hos patienter med eksisterende renal dysfunktion.
English: Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available (see section 4.4 and 5.1).
Danish: Aprotinin bør kun anvendes efter nøje vurdering af fordele og risici og under hensyntagen til, at alternative behandlingsformer er tilgængelige (se pkt.
English: Aprotinin is indicated for prophylactic use to reduce blood loss and blood transfusion in adult patients who are at high risk of major blood loss undergoing isolated cardiopulmonary bypass graft surgery (i.e. coronary artery bypass graft surgery that is not combined with other cardiovascular surgery).
Danish: Aprotinin er indiceret til profylaktisk brug for at reducere blodtab og blodtransfusion hos voksne patienter, der har en stor risiko for et stort blodtab under en isoleret koronararterie bypass graft operation (dvs. en koronar bypass-operation, der ikke er kombineret med anden kardiovaskulær kirurgi).
English: In patients undergoing cardiopulmonary bypass with aprotinin therapy, one of three methods is recommended to maintain adequate anticoagulation: Activated Clotting Time (ACT), Fixed Heparin Dosing, or Heparin Titration (see below).
Danish: Hos patienter, som gennemgår kardiopulmonal bypass med aprotinin-behandling, anbefales én af tre metoder for at opretholde tilstrækkelig antikoagulation: ACT (Activated Clotting Time), fast heparindosering eller heparintitrering (se nedenfor).
English: If any of these apply to you, your doctor will decide whether <Aprotinin-containing medicinal product> is suitable for you or not.
Danish: Hvis noget af dette gælder for dig, vil din læge beslutte, om <lægemiddel, der indeholder aprotinin> er det rigtige for dig.
English: • Fixed Heparin Dosing
Danish: • Fast heparin-dosering
English: Disseminated intravascular coagulation Coagulopathy
Danish: Dissemineret intravaskulær koagulation