FrancophonIA/ELRC3.0 huggingface dataset:
English: Antithrombin, a 58 kD, 432 amino-acid glycoprotein, belongs to the serpin (serine protease inhibitor) superfamily.
Danish: Antithrombin, et 58 kD, 432 aminosyre glykoprotein, tilhører superfamilien serpin (serin proteasehæmmer).
English: It is used when the patients are having surgery, to prevent problems due to the formation of blood clots in the vessels.
Danish: Det bruges, når patienten skal opereres, for at forebygge problemer på grund af dannelsen af blodpropper i karrene.
English: The following information is intended for healthcare professionals only: This medicine is intended for single use only.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Dette lægemiddel er kun beregnet til engangsbrug.
English: It is unknown whether it is present in breast milk.
Danish: Det vides ikke, om det udskilles i modermælk.
English: To protect you from developing blood clots the medicine will continue to be administered to you until your doctor determines it safe to stop treatment.
Danish: For at beskytte Dem mod dannelsen af blodpropper indgives lægemidlet fortløbende indtil lægen beslutter, at det er sikkert at afbryde behandlingen.
English: As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Danish: Som for alle intravenøse proteinprodukter kan der eventuelt opstå allergiske overfølsomhedsreaktioner.
English: The first contains the reactive centre and provides a cleavage site for proteinases such as thrombin, a prerequisite for forming a stable proteinaseinhibitor complex.
Danish: Det første indeholder det reaktive center og udgør et spaltningssted for proteinaser som thrombin, hvilket er en forudsætning for at danne et stabilt proteinasehæmmer-kompleks.
English: Normal sodium chloride solution 9 mg/ml (0.9%) may be added to dilute to a concentration convenient for
Danish: Natriumkloridopløsning 9 mg/ml (0,9 %) kan tilsættes for at fortynde til en koncentration, der er egnet til
English: Read all of this leaflet carefully before you start using this medicine because it contains important
Danish: Læs denne indlægsseddel grundigt, inden du begynder at bruge dette lægemiddel, da den
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: ATryn kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Antithrombin alfa should therefore not be used in pregnant women.
Danish: Antithrombin alfa bør derfor ikke anvendes til gravide kvinder.
English: Therapeutic Monitoring and Dose Adjustment
Danish: Terapeutisk overvågning og dosisjustering
English: This medicine has been authorised under ‘exceptional circumstances'.
Danish: Dette lægemiddel er godkendt under ”særlige omstændigheder”.
English: Subsequently, antithrombin activity should be checked 1-2 times a day and dose adjustments made accordingly.
Danish: Efterfølgende skal antithrombin-aktiviteten kontrolleres 1-2 gange om dagen, og dosis justeres tilsvarende.
English: This medicine is intended for single use only.
Danish: Dette lægemiddel er kun beregnet til engangsbrug.
English: During consumptive states (e.g. major surgery, concomitant use of heparin) the actual dose may be higher.
Danish: I tilstande med stort forbrug (f.eks. større operationer, samtidig brug af heparin) kan den faktiske dosis være højere.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Danish: De ikke-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet og toksicitet i forbindelse med
English: Therefore it is not recommended to breastfeed whilst being treated with this medicine.
Danish: Det anbefales derfor ikke at amme under behandling med dette lægemiddel.
English: The factors most strongly inhibited are thrombin and Factor Xa, but also factors of contact activation, intrinsic system and the Factor VIIa/tissue factor complex.
Danish: De faktorer, der hæmmes kraftigst, er thrombin og Faktor Xa, men også faktorer for kontaktaktivering, det interne koagulationssystem og Faktor VIIa/vævsfaktorkompleks hæmmes.
English: Do not use this medicine after the expiry date stated which is stated on the carton and vial label after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningens og hætteglassets mærkat.
English: This medicinal product has been authorised under ‘exceptional circumstances'.
Danish: Dette lægemiddel er godkendt under “særlige omstændigheder”.
English: It is unknown whether antithrombin alfa or its metabolites are excreted in human milk.
Danish: Det er ukendt, om antithrombin alfa eller dets metabolitter udskilles i human mælk.
English: Pharmacotherapeutic Group: Antithrombotic agents: heparin group; ATC code: B01AB02.
Danish: Farmakoterapeutisk klassifikation: Antithrombotiske midler: heparingruppe, ATC-kode: B01AB02.
English: Therefore your doctor will carefully monitor the use of this medicine when administered together with these anti-clotting medicines.
Danish: Derfor vil Deres læge omhyggeligt overvåge brugen af dette lægemiddel, når det gives sammen med medicin, der
English: In studies with ATryn the following side effects were reported: Common side effects (may affect up to 1 in 10 people) are:
Danish: I undersøgelser med ATryn er følgende bivirkninger indberettet: Almindelige bivirkninger (kan ramme 1 ud af 10 mennesker):
English: No antibodies to antithrombin alfa have been detected up to 90 days following treatment with ATryn.
Danish: Der er ikke observeret antistoffer over for antithrombin alfa op til 90 dage efter behandling med ATryn.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1, 10 OR 25 VIALS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON (1, 10 ELLER 25 HÆTTEGLAS)
English: • Area under the curve: 587.88 ± 1.63 (% x h)
Danish: ● Areal under kurven: 587,88 ± 1,63 (% x timer)
English: The safety and efficacy of ATryn in children and adolescents (<18 years) have not been established.
Danish: ATryns sikkerhed og virkning hos børn og unge i alderen <18 år er ikke klarlagt.
English: Treatment should be continued until the risk for venous thromboembolisms is reduced and/or when effective follow-on anticoagulation has been established.
Danish: Behandlingen skal fortsættes, indtil risikoen for venøs tromboembolisme er reduceret, og/eller til effektiv opfølgende antikoagulerende behandling er
English: The other ingredients are: glycine, sodium chloride, sodium citrate
Danish: Øvrige indholdsstoffer: glycin, natriumchlorid, natriumcitrat
English: - Antithrombin levels should be measured daily, in order to adjust the individual dose.
Danish: - Antithrombin-niveauerne skal måles hver dag for at justere den enkelte dosis.
English: Check AT activity level 30 minutes after any change in infusion rate, or four hours after a value within the target range.
Danish: Kontroller AT-aktivitetsniveauet 30 minutter efter enhver ændring af infusionshastigheden eller fire timer efter en værdi, der ligger inden for det terapeutiske mål.
English: The solution should be slightly yellow, clear to slightly opalescent.
Danish: Opløsningen skal være let gul, klar til let opaliserende.
English: The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag with a 0.22 micron pore size in-line filter.
Danish: Det rekonstituerede produkt skal indgives ved intravenøs infusion ved hjælp af en steril engangssprøjte eller en infusionspose med in-line filter med porestørrelse på 0,22 mikron.
English: Upon complete dissolution, the reconstituted product may be drawn up into a sterile disposable syringe.
Danish: Efter fuldstændig opløsning kan det rekonstituerede produkt trækkes op i en steril engangssprøjte.
English: Do not use solutions that
Danish: Brug ikke opløsninger, der er uklare eller
English: ATryn contains antithrombin alfa which is similar to the naturally occurring human antithrombin.
Danish: ATryn indeholder antithrombin alfa, som svarer til det naturligt forekommende humane antithrombin.
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Danish: Ikke almindelige bivirkninger (kan ramme 1 ud af 100 mennesker):
English: This medicinal product contains 1.65 mmol (or 37.9 mg) sodium per vial.
Danish: Dette lægemiddel indeholder 1,65 mmol (eller 37,9 mg) natrium pr. hætteglas.
English: The specific activity of ATryn is approximately 7 IU/mg protein.
Danish: ATryns specifikke aktivitet er cirka 7 IE/mg protein.
English: In the treatment of congenital antithrombin deficiency, the dose and duration of treatment should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment.
Danish: Ved behandling af medfødt antithrombinmangel skal dosis- og behandlings varighed individualiseres for hver enkelt patient, idet der tages højde for familiemæssig baggrund med hensyn til tromboemboliske hændelser, de faktiske kliniske risikofaktorer og laboratoriemæssige vurderinger.
English: • Mean residence time (MRT): 8.57 ± 1.24 h
Danish: ● Gennemsnitlig residenstid (MRT): 8,57 ± 1,24 timer
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglasmærkat
English: The second is a glycosaminoglycan binding domain responsible for the interaction with heparin and related substances, which accelerates the inhibition of thrombin.
Danish: Det andet er et glykosaminoglykan-bindende område, der er ansvarligt for interaktionen med heparin og relaterede stoffer, der forøger thrombin-hæmningen.
English: Antithrombin (AT) activity in plasma is expressed either as a percentage (relative to human plasma) or in International Units (relative to the International Standard for antithrombin in plasma).
Danish: Antithrombin (AT) aktivitet i plasma udtrykkes enten som en procent (i forhold til humant plasma) eller i internationale enheder (i forhold til den internationale standard for antithrombin i plasma).
English: See therapeutic monitoring and dose adjustment recommendations below.
Danish: Se anbefalingerne vedrørende terapeutisk overvågning og dosisjustering nedenfor.
English: Due to differences in pharmacokinetics of antithrombin alfa and plasma-derived antithrombin, treatment should follow the specific dose recommendations described below.
Danish: På grund af forskellene i farmakokinetik for antithrombin alfa og plasmaderiveret antithrombin skal behandling følge de specifikke dosisanbefalinger, der er beskrevet i det følgende.
English: Frequent antithrombin activity assessments and dosing adjustments may be necessary when starting treatment and just
Danish: Hyppig måling af antithrombin-aktivitet og dosisjusteringer kan være nødvendige ved behandlingsstart og
English: It is possible that the surgical procedure will influence AT activity levels.
Danish: Det operative indgreb kan muligvis påvirke AT-aktivitetsniveauerne.
English: Prior to launch of Atryn in each Member State the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af ATryn i hver medlemstat, skal indehaveren af markedsføringstilladelsen og de nationale tilsynsmyndigheder være enige om indholdet og formatet af undervisningsprogrammet, herunder kommunikationsmedier, distributionsmodaliteter og alle øvrige aspekter af programmet.
English: No information is available on the possible effects of antithrombin alfa on male and female fertility.
Danish: Der findes ingen oplysninger om antithrombin alfa mulige indvirkning på mandlig og kvindelig fertilitet.
English: This medicine contains 38 mg (1.65 mmol) sodium per 10 ml vial.
Danish: Dette lægemiddel indeholder 38 mg (1,65 mmol) natrium pr. 10 ml hætteglas.
English: The MAH will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.
Danish: Indehaveren af markedsføringstilladelsen vil sikre, at der i det materiale, som gøres tilgængeligt for lægestanden, er oplysninger om postmarketing overvågningsprogrammet og immun-overvågningsprogrammet.
English: Limited clinical data are available on the use of antithrombin alfa in pregnant women.
Danish: Der er begrænsede kliniske data til rådighed vedrørende brug af antithrombin alfa til gravide kvinder.
English: The half-life of recombinant antithrombin may be altered with concomitant treatment with these anticoagulants due to an altered antithrombin turnover.
Danish: Halveringstiden for rekombinant antithrombin kan ændres ved samtidig behandling med disse koagulationshæmmere på grund af en ændret antithrombin-omsætning.
English: After reconstitution, from a microbiological pointy of view, this medicinal product should be used immediately.
Danish: Fra en mikrobiologisk synsvinkel skal produktet anvendes umiddelbart efter rekonstitution.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Danish: E. SÆRLIG FORPLIGTELSE TIL AT AFSLUTTE FORANSTALTNINGER EFTER UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE TIL LÆGEMIDLER
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Danish: Patienterne skal informeres om de tidlige tegn på overfølsomhedsreaktioner, herunder nældefeber, generel urticaria, trykken for brystet, hvæsende vejrtrækning, hypotension og anafylaksi.
English: The required maintenance dose for surgical patients is given as a continuous infusion and is determined using the following formula:
Danish: Den nødvendige vedligeholdelsesdosis til kirurgiske patienter gives som en kontinuerlig infusion og beregnes ved hjælp af følgende formel:
English: Animal studies performed in rats did not indicate harmful effects on parturition, embryonal/foetal and post-natal development.
Danish: Dyreforsøg med rotter antyder ingen skadelige virkninger på fødselsforløb, fosterudvikling og udvikling efter fødslen.
English: If you experience hives, itchy welts or wheals all over the skin, tightness of the chest, wheezing (difficulty breathing), you should immediately contact your physician since these might be symptoms of a severe allergic reaction.
Danish: Hvis De oplever nældefeber, kløende rande eller pletter overalt på huden, trykken for brystet, hvæsende vejrtrækning (problemer med at trække vejret), skal De straks kontakte Deres læge, da dette kan være symptomer på en svær allergisk reaktion.
English: Protocol GTC AT HD 012-04: A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis.
Danish: Protokol GTC AT HD 012-04: Et multicenter, multinationalt studie for at undersøge sikkerheden og effekten af antithrombin alfa hos patienter med medfødt antithrombin (AT) mangel i situationer med høj risiko for trombose.
English: If you have an inborn deficiency of antithrombin, your blood level of antithrombin is lower than normal.
Danish: Hvis De lider af medfødt antithrombin-mangel, er indholdet af antithrombin i Deres blod lavere end normalt.
English: The antithrombin activity level should be maintained above 80% for the duration of the treatment, unless clinical particulars would indicate a different effective level.
Danish: Antithrombin-aktivitetsniveauet skal opretholdes over 80 % under hele behandlingen, med mindre kliniske forhold indikerer et andet effektivitetsniveau.
English: • Distribution half-life: 1.74 ± 1.28 h, elimination half-life: 10.16 ± 1.28 h.
Danish: ● Initial halveringstid: 1,74 ± 1,28 timer, terminal halveringstid: 10,16 ± 1,28 timer
English: Package leaflet: Information for the user ATryn 1750 IU powder for solution for infusion antithrombin alfa (rDNA) This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til brugeren ATryn 1.750 IE pulver til infusionsvæske, opløsning antithrombin alfa (rDNA) Dette lægemiddel er underlagt supplerende overvågning.
English: After reconstitution, 1 ml of solution contains
Danish: Efter rekonstitution indeholder 1 ml
English: However due to the difference in pharmacokinetic characteristics of this medicine in pregnant versus non-pregnant patients no recommendation for dosing in pregnancy can be given at this time (see section 4.4).
Danish: På grund af forskellene i de farmakokinetiske egenskaber for dette lægemiddel hos gravide i forhold til ikke-gravide patienter kan der ikke gives nogen anbefaling for dosering til gravide patienter på nuværende tidspunkt (se pkt.
English: This may result in a higher tendency to form clots in your blood vessels.
Danish: Dette kan føre til en øget tendens til blodpropdannelse i blodkarrene.
English: It is normally given in association with heparin or low molecular weight heparin (another medicine that helps to prevent blood clots).
Danish: Det gives som regel sammen med heparin eller lavmolekylært heparin (et andet lægemiddel, som hjælper med at forhindre blodpropper).
English: The powder should be reconstituted with 10 ml of water for injections (WFI) injected along the side wall of the vial and gently swirled (not shaken) to prevent foaming.
Danish: Pulveret skal rekonstitueres med 10 ml vand til injektionsvæsker, der injiceres langs hætteglassets side, og hætteglasset svinges forsigtigt rundt (må ikke rystes) for at undgå skumdannelse.
English: In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
Danish: I kroppen blokerer antithrombin thrombin, som er et stof, der har en vigtig rolle i dannelsen af blodpropper.
English: It is normally given in association with heparin or low molecular weight
Danish: Det administreres normalt sammen med heparin eller lavmolekylært
English: * potency (IU) determined using European Pharmacopoeial chromogenic assay.
Danish: * styrken (IE) bestemmes ved hjælp af den Europæiske Farmakopés kromogen-analyse.
English: Detailed information on this product is available on the website of the European Medicines Agency
Danish: De kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs
English: The MAH shall ensure that in each Member State where Atryn is marketed, all healthcare professionals who are expected to prescribe and use Atryn have access to/are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal i hver medlemsstat, hvor ATryn markedsføres, sørge for, at sundhedsprofessionelle, som det forventes vil ordinere og bruge ATryn, har adgang til/forsynes med den
English: Injury and poisoning and procedural complications Common
Danish: Traumer, forgiftninger og behandlingskomplikationer
English: Initial treatment starts with a loading dose targeting an antithrombin activity level of 100%.
Danish: Den indledende behandling starter med en bolusdosis, der stiler mod et aktivitetsniveau for antithrombin på 100 %.
English: Any unused medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel skal bortskaffes i henhold til lokale retningslinjer.
English: In other clinical trials with acquired antithrombin deficient cardiac surgery patients (n=118) and healthy volunteers (n=102), undesirable effects reported to be related to treatment with ATryn that were observed more than once are listed by System Organ Class in the table below.
Danish: I andre kliniske forsøg med patienter med erhvervet antithrombinmangel under hjerteoperation (n=118) og raske frivillige forsøgspersoner (n=102) er bivirkninger, der er indberettet som relateret til behandling med ATryn, og som er indberettet mere end én gang, anført efter systemorganklasse i nedenstående tabel.
English: The dose should be adjusted on the basis of laboratory measurements of antithrombin activity.
Danish: Dosis skal justeres på basis af laboratoriemålinger af antithrombin-aktivitet.
English: Other medicines and ATryn
Danish: Brug af anden medicin sammen med ATryn
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Det skal tages med ind i overvejelserne hos patienter, som er på kontrolleret natriumkost.
English: If these symptoms occur after administration, they should contact their physician.
Danish: Hvis disse symptomer opstår efter indgivelse, skal lægen kontaktes.
English: This antibody testing should be provided upon request of a physician and when the MAH receives a report suggestive of a possible immune
Danish: Denne antistoftest skal tilbydes ved forespørgsel fra en læge, og når indehaveren af markedsføringstilladelsen modtager en rapport, som kunne tyde på en mulig immunreaktion eller mangel
English: In case of shock, standard medical treatment should be administered.
Danish: I tilfælde af chok skal medicinsk
English: Hypersensitivity to goat proteins or goat milk components.
Danish: Overfølsomhed over for gedeproteiner eller gedemælk.
English: After the start of the maintenance dose infusion, blood for AT activity levels should be drawn at 45 minutes after the start of the loading dose infusion.
Danish: Efter start på infusion af vedligeholdelsesdosis skal der udtages blodprøver til analyse af ATaktivitetsniveauer 45 minutter efter start på infusion af bolusdosis.
English: The active substance is antithrombin alfa*: 1750 IU.
Danish: Aktivt stof: antithrombin alfa*: 1.750 IE.
English: The risk of diminution of antithrombin levels by prolonged treatment with a non-fractionated heparin should be
Danish: Risikoen for reduktion af antithrombin-niveauerne ved længerevarende behandling med ufraktioneret heparin
English: In case the activity level is below 80% a 15 minutes bolus infusion of AT can be given to quickly restore the AT activity level.
Danish: Hvis aktivitetsniveauet er under 80 %, kan der gives en 15-minutters bolusinfusion af AT for hurtigt at genoprette AT-aktivitetsniveauet.
English: After intravenous administration of ATryn (intravenous bolus dose of 50 IU/kg or 100 IU/kg body weight) to congenital antithrombin deficient patients without clinical symptoms of thrombosis, and not using heparin, the incremental recovery was 2.07 ± 1.54 %/IU/kg body weight (mean ± SD).
Danish: Efter intravenøs indgivelse af ATryn (intravenøs bolusdosis på 50 IE/kg eller 100 IE/kg legemsvægt) til patienter med medfødt antithrombinmangel, som var uden kliniske symptomer på trombose, og som ikke anvendte heparin, var aktivitetsstigningen 2,07 ± 1,54 %/IE/kg legemsvægt (gennemsnit ± SD).
English: One International Unit (IU) of antithrombin activity is equivalent to that quantity of antithrombin in one ml of normal human plasma.
Danish: En international enhed (IE) af antithrombin-aktivitet svarer til indholdet af antithrombin i 1 ml normal human plasma.
English: Around major surgical procedures this tendency to clot is even more increased.
Danish: I forbindelse med større operationer øges denne tendens til blodpropdannelse yderligere.