FrancophonIA/ELRC3.0 huggingface dataset:
English: Powder in glass vial (type I) with a stopper (siliconized bromobutyl rubber) and capped with a seal (aluminum) and flip-off cap (plastic).
Danish: Pulver i hætteglas af glas (type I) med prop (siliconebehandlet brombutylgummi) dækket af en aluminiumforsegling og en plasthætte, der kan vippes af.
English: In a formal clinical trial employing serial Duplex ultrasound examinations, antithrombin alfa was shown to be effective in the prevention of thromboembolic events in fourteen congenital antithrombin deficient patients in clinical high risk situations.
Danish: I et formelt klinisk forsøg med en serie af Duplex ultralydsundersøgelser blev det påvist, at antithrombin alfa var effektivt til forebyggelse af tromboemboliske hændelser hos fjorten patienter med medfødt antithrombinmangel, der befandt sig i kliniske højrisikosituationer.
English: Paediatric antithrombin levels may be different from adult levels, particularly in neonates.
Danish: Pædiatriske antithrombinniveauer, især hos nyfødte, kan adskille sig fra de niveauer, der ses hos voksne.
English: - In order to properly adjust the dose of the anticoagulant and to avoid excessive hypocoagulability, controls of the extent of anticoagulation (APTT, and where appropriate anti-Factor Xa activity) should be performed regularly, at close intervals and in particular in the first minutes/hours following the start
Danish: - For at kunne justere dosis af koagulationshæmmeren korrekt og undgå for stor hypokoagulabilitet skal der jævnligt og med korte mellemrum udføres kontrol af omfanget af koagulationshæmningen (APTT og, hvor det er relevant, anti-Faktor Xa-aktivitet).
English: - If you have any further questions, ask your doctor.
Danish: - Spørg lægen hvis der er mere, De vil vide.
English: The most serious reported adverse reactions observed in clinical trials are haemorrhage and post procedural
Danish: De alvorligste indberettede bivirkninger, der blev observeret i kliniske forsøg, er blødning og blødning
English: Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, France
Danish: Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, Frankrig
English: In case the AT activity level is between 80% and 120% (0.8 - 1.2 IU/ml), no dose adjustment is needed.
Danish: Hvis AT-aktivitetsniveauet er mellem 80 % og 120 % (0,8-1,2 IE/ml), er dosisjustering ikke nødvendig.
English: Antithrombin activity is greatly enhanced by heparin and the anticoagulant effects of heparin depend on the presence of antithrombin.
Danish: Antithrombin-aktiviteten forøges kraftigt af heparin, og heparins koagulationshæmmende virkning afhænger af tilstedeværelsen af
English: The number of units of antithrombin alfa administered is expressed in International Units (IU), which is related to the current WHO standard for antithrombin concentrate.
Danish: Antal indgivne enheder af antithrombin alfa udtrykkes i internationale enheder (IE) i forhold til den aktuelle WHO-standard for antithrombin-koncentrat.
English: The dose can be calculated utilizing the post-surgical AT activity in the loading dose formula above.
Danish: Dosis kan beregnes ved hjælp af AT-aktiviteten efter operationen i ovenstående formel for bolusdosis.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ATryn therapy taking into account the benefit of breastfeeding for the child and the
Danish: Det skal besluttes, om amning eller behandling med ATryn skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for
English: Clinical and biological surveillance when antithrombin is used together with heparin, low molecular weight heparin or other anticoagulants which potentiate the anticoagulant activity of antithrombin:
Danish: Klinisk og biologisk overvågning når antithrombin anvendes sammen med heparin, lavmolekylært heparin eller andre koagulationshæmmere, der forstærker antithrombins koagulationshæmmende
English: This medicine is used in patients who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Danish: Dette lægemiddel bruges til patienter som lider af medfødt mangel på proteinet antithrombin (kongenit antithrombinmangel).
English: Prior to launch in any EU Member State, the MAH will set up a post-marketing surveillance programme to collect the following information about congenital AT deficient patients treated with ATryn
Danish: Før markedsføring i noget land i EU, vil Indehaveren af markedsføringstilladelsen have et post-marketing overvågningssystem på plads for at indsamle følgende oplysninger om patienter med medfødt AT-mangel,
English: The required loading dose is determined using the following formula:
Danish: Den nødvendige bolusdosis beregnes ved hjælp af følgende formel:
English: Prior to launch in any EU Member State, the MAH will set up an immunosurveillance programme and provide antibody testing for anti-ATryn antibodies to physicians.
Danish: b) Før markedsføring i noget land i EU vil indehaveren af markedsføringstilladelsen oprette et immun-overvågningsprogram og tilbyde læger antistoftest for anti-ATryn antistoffer.
English: If you use more ATryn than you should
Danish: Hvis De holder op med at bruge ATryn
English: Some additional data have been obtained from a number of patients in
Danish: Yderligere data er opnået fra et antal patienter under et compassionate use program.
English: The reconstituted product should be inspected visually for particulate matter and/or discolouration prior to administration.
Danish: Det rekonstituerede produkt skal inspiceres visuelt for partikler og/eller misfarvning forud for indgivelse.
English: Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e.g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Danish: Antithrombin-erstatning under indgivelse af koagulationshæmmere, der forstærker antithrombins koagulationshæmmende virkning (f.eks. heparin, lavmolekylært heparin), kan øge risikoen for blødning.
English: The usual loading dose in surgical patients (baseline AT activity 50%, bodyweight 75 kg) with congenital antithrombin deficiency in clinical risk situations is 20-25 IU/kg bodyweight.
Danish: Den normale bolusdosis til kirurgiske patienter (baseline AT-aktivitet 50 %, legemsvægt 75 kg) med medfødt antithrombinmangel, som befinder sig i kliniske risikosituationer, er 20-25 IE/kg legemsvægt.
English: In clinical trials involving congenital antithrombin deficient patients (n=35) one mild undesirable effect of “application site pruritis” was reported as related to treatment with ATryn.
Danish: I kliniske forsøg med patienter med medfødt antithrombinmangel (n=35) blev én mild bivirkning i form af "pruritis på infusionsstedet" indberettet som relateret til behandling med ATryn.
English: Dizziness headache
Danish: Almindelig Svimmelhed Hovedpine
English: ATryn is supplied as a powder for solution for infusion (1750 IU powder in vial).
Danish: ATryn leveres som pulver til infusionsvæske, opløsning (1750 IE pulver i hætteglas).
English: Vials should be brought at temperature not above 25°C prior to reconstitution.
Danish: Hætteglas skal have stuetemperatur (ikke over 25 °C) før rekonstitution.
English: The loading dose should be given as a 15 minute infusion immediately followed by initiation of the maintenance infusion.
Danish: Bolusdosis skal gives som en 15-minutters infusion, der øjeblikkeligt efterfølges af iværksættelse af vedligeholdelsesinfusionen.
English: The usual maintenance dose in surgical patients with congenital antithrombin deficiency in clinical risk situations is 4-5 IU/kg/h.
Danish: Den normale vedligeholdelsesdosis til kirurgiske patienter med medfødt antithrombinmangel, som befinder sig i kliniske risikosituationer, er 4-5 IE/kg/time.
English: After reconstitution, 1 ml of solution contains 175 IU
Danish: Efter rekonstitution indeholder 1 ml opløsning 175 IE
English: Feeling hot
Danish: • følelse af varme
English: The calculation of the required dosage of antithrombin alfa is based on pre-treatment plasma antithrombin activity and body weight.
Danish: Beregningen af den nødvendige dosis antithrombin alfa er baseret på antithrombin-aktivitet før behandlingen og patientens legemsvægt.
English: In case the AT activity level is less than 80%, increase the maintenance infusion rate by 50%.
Danish: Hvis AT-aktivitetsniveauet er under 80 %, øges hastigheden af vedligeholdelsesinfusionen med 50 %.
English: • feeling hot • infusion site reactions such as pain, bruising and redness
Danish: • reaktioner på infusionsstedet som f.eks. smerte, blå mærker og rødme
English: The reconstituted solution should be inspected visually for particulate matter and/or discolouration prior to administration.
Danish: Den rekonstituerede opløsning skal inspiceres visuelt for partikler og/eller misfarvning forud for indgivelse.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with congenital antithrombin deficiency.
Danish: Deres behandling påbegyndes under overvågning af en læge, som har erfaring med behandling af patienter med medfødt mangel på antithrombin.
English: Post procedural haemorrhage Wound secretion
Danish: Almindelig Blødning efte rindgrebet Sårsekretion
English: In case the AT activity level is greater than 120% decrease the infusion rate by 30%.
Danish: Hvis AT-aktivitetsniveauet er større end 120 %, reduceres infusionshastigheden med 30 %.
English: ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of adult patients with congenital antithrombin deficiency.
Danish: ATryn er indiceret til forebyggelse af venøs tromboembolisme under operation af voksne patienter med medfødt antithrombinmangel.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført under pkt.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.Det muliggør løbende overvågning af benefit/risk-forholdet for lægemidlet.
English: The loading dose should be given as a 15 minute infusion immediately followed by initiation of the
Danish: Bolusdosis skal gives som en 15-minutters infusion, der øjeblikkeligt efterfølges af iværksættelse af
English: After reconstitution, 1 ml of solution contains 175 IU antithrombin alfa.
Danish: Efter rekonstitution indeholder 1 ml opløsning 175 IE antithrombin alfa.
English: This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for dette lægemiddel fordi det drejer sig om en sjælden sygdom.
English: If diluted, the solution prepared in infusion bags should be administered immediately and no longer than 8 hours after dilution.
Danish: Ved fortynding skal opløsningen efter klargøring i infusionsposer indgives med det samme og højst 8 timer efter fortynding.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold for det rekonstituerede lægemiddel, se pkt.
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Danish: Ikke anvendte lægemidler samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: The most commonly reported adverse reactions observed in clinical trials are dizziness, headache, haemorrhage, nausea, venipuncture site haemorrhage, post procedural haemorrhage and wound secretion.
Danish: De mest almindelige indberettede bivirkninger, der blev observeret i kliniske forsøg, omfatter svimmelhed, hovedpine, blødning, kvalme, blødning på venepunkturstedet, blødning efter indgrebet og
English: Powder for solution for infusion (1750 IU)
Danish: Pulver til infusionsvæske, opløsning (1.750 IE)
English: * recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA
Danish: * rekombinant humant antithrombin fremstillet ved hjælp af rekombinant DNA-teknologi (rDNA) i mælk
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag
English: ATryn 1750 IU powder for solution for infusion.
Danish: ATryn 1.750 IE pulver til infusionsvæske, opløsning.
English: The reconstituted solution should be used immediately and no longer than 3 hours after reconstitution.
Danish: Den rekonstituerede opløsning skal anvendes umiddelbart efter og højst 3 timer efter rekonstitution.
English: The contents of the syringes should be administered immediately and no longer than 3 hours after reconstitution.
Danish: Indholdet af sprøjterne skal indgives med det samme og højst 3 timer efter rekonstitution.
English: Infusion site erythema Infusion site pain Infusion site rash Venipuncture site bruise
Danish: Erytem på infusionsstedet Smerte på infusionsstedet Udslæt på infusionsstedet Suggilation på venepunkturstedet
English: ATryn 1750 IU powder for solution for infusion
Danish: ATryn 1.750 IE pulver til infusionsvæske, opløsning
English: This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Danish: Det betyder, at det af videnskabelige årsager ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet, fordi det anvendes til en sjælden sygdom.
English: ** recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA
Danish: ** rekombinant humant antithrombin fremstillet ved hjælp af rekombinant DNA-teknologi (rDNA) i
English: Thus, concurrent administration of antithrombin with heparin, low molecular weight heparin, or other anticoagulants that potentiate the anticoagulant activity of antithrombin to a patient with increased risk of bleeding must be monitored clinically and biologically.
Danish: I de tilfælde, hvor antithrombin og heparin, lavmolekylært heparin eller andre koagulationshæmmere, der forstærker antithrombins koagulationshæmmende aktivitet, indgives samtidigt til en patient, der har øget risiko for blødning, skal der derfor udføres klinisk og biologisk overvågning.
English: This initial loading dose is based on body weight and on the pretreatment antithrombin activity level.
Danish: Denne indledende bolusdosis er baseret på legemsvægt og på aktivitetsniveauet for
English: Due to differences in pharmacokinetic characteristics of ATryn in pregnant versus non-pregnant patients, recommendations for dosing in pregnancy or in the peripartum period cannot be given.
Danish: Der kan ikke gives nogen anbefaling for dosering under graviditet eller peripartum perioden på grund af forskellene i de farmakokinetiske egenskaber for ATryn hos gravide i forhold til ikke-gravide patienter.
English: One vial contains nominally 1750 IU antithrombin alfa*.
Danish: Et hætteglas indeholder nominelt 1.750 IE antithrombin alfa*.
English: One vial contains nominally 1750 IU* antithrombin alfa**.
Danish: Et hætteglas indeholder nominelt 1.750 IE* antithrombin alfa**.
English: The therapeutic goal of treatment with antithrombin alfa is to increase to, and maintain antithrombin activity between 80 - 120% of normal (0.8 - 1.2 IU/ml) for the duration of treatment.
Danish: Det terapeutiske mål for behandling med antithrombin alfa er at øge til en antithrombin-aktivitet på mellem 80-120 % af normalen (0,8-1,2 IE/ml) og bevare dette niveau under hele behandlingen.
English: Marketing Authorisation Holder and Manufacturer
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaveren af markedsføringstilladelsen
English: Maintenance dose (IU/hour) = [(100 - patient's pre-treatment AT activity level in %) /10.22] x Body Weight in kg
Danish: Vedligeholdelsesdosis (IE/time) = [(100 - patientens AT-aktivitetsniveau i % før behandling) / 10,22] x legemsvægt i kg
English: • nausea
Danish: • kvalme.
English: The therapeutic goal of treatment with antithrombin alfa is to increase to, and maintain antithrombin activity between 80 - 120% (0.8 - 1.2 IU/ml) for the duration of treatment.
Danish: Det terapeutiske mål for behandling med antithrombin alfa er at øge til en antithrombin-aktivitet på mellem 80-120 % (0,8-1,2 IE/ml) og bevare dette niveau under hele behandlingen.
English: Name and address of the manufacturer(s) of the biological active substance(s) Therapure Biopharma Inc.
Danish: Therapure Biopharma Inc.
English: Normal antithrombin activity in adults is 80 - 120% (0.8-1.2 IU/ml) and levels in neonates are about
Danish: Normal antithrombin-aktivitet hos voksne er 80-120 % (0,8-1,2 IE/ml).
English: Loading dose (IU) = [(100 - patient's pre-treatment AT activity level in %) /2.28] x Body Weight in kg
Danish: Bolusdosis (IE) = [(100 - patientens AT-aktivitetsniveau i % før behandling) / 2,28] x legemsvægt i kg
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: Due date reaction or lack of efficacy.
Danish: Bivirkninger inklusiv mangel på effekt
English: Adverse drug reactions including lack of efficacy Physicians should be encouraged to enrol patients in the surveillance programme and results of the surveillance should be provided in the update to the EU-RMP or at the time of the annual reassessment, whichever comes first.
Danish: Resultater af denne overvågning skal gives i en opdatering af EU risk management plan eller på tidspunktet for den årlige revurdering, hvis det sker
English: MedDRA SOC
Danish: ZA de Courtaboeuf
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette præparat ikke
English: When ATryn is used together with heparin (an anti-clotting medicine), or some other anti-clotting medicines, this may increase the risk of bleeding.
Danish: Fortæl det altid til lægen eller på apoteket, hvis De bruger, for nylig har brugt eller eventuelt skal tage Når ATryn anvendes sammen med heparin (et lægemiddel, der modvirker dannelse af blodpropper) eller visse andre lægemidler, der modvirker blodpropper, kan dette øge risikoen for blødning.
English: Adverse reactions
Danish: Indgivelsesmåde
English: If you get any side effects, talk to your doctor.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: The doctor will treat you, as appropriate, if you have any particular side effects.
Danish: Hvis De får nogen særlige bivirkninger, vil lægen behandle Dem efter behov.
English: - if you are allergic to antithrombin alfa or any of the other ingredients of this medicine (listed in section - if you are allergic to goat products as antithrombin alfa is produced in the milk of transgenic goats by
Danish: - Hvis De er overfølsom (allergisk) over for antithrombin alfa eller et af de øvrige indholdsstoffer.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE
English: Nausea
Danish: Almindelig Kvalme
English: SPECIAL STORAGE CONDITIONS
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING
English: Maintenance dose (IU/hour) = [(100 - patient's pre-treatment AT activity level in %) /10.22] x Body
Danish: Vedligeholdelsesdosis (IE/time) = [(100 - patientens AT-aktivitetsniveau i % før behandling) /
English: Venipuncture site haemorrhage
Danish: Mave-tarm-kanalen
English: These signs may be:
Danish: Disse tegn kan være:
English: 4- Repeat this cleaning process 3 times.
Danish: 4- Gentag denne rengøringsproces 3 gange.
English: If your child:
Danish: Hvis dit barn:
English: What it is used for
Danish: Hvad det anvendes til
English: • one in the morning
Danish: • Én om morgenen
English: Do not lie the child down immediately after the administration.
Danish: Læg ikke barnet ned straks efter administration.
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: 2 KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: Appropriate monitoring of the child is required until symptoms disappear.
Danish: En passende overvågning af barnet er påkrævet, indtil symptomerne forsvinder.
English: • one in late afternoon
Danish: • Én sidst på eftermiddagen
English: Before opening: 3 years.
Danish: Før åbning: 3 år.
English: Be careful, do not push the plunger in during this step.
Danish: Vær forsigtig, skub ikke stemplet ned under dette trin.
English: 10 DATE OF REVISION OF THE TEXT
Danish: 10 DATO FOR ÆNDRING AF TEKSTEN
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data)
Danish: Frekvensen af følgende bivirkninger er ukendt (frekvensen kan ikke beregnes ud fra de tilgængelige data)
English: Propylene glycol………………………………………………….2.60 mg.
Danish: Propylenglycol…………………………………………………..2,60 mg
English: • at least 9 hours interval between two intakes
Danish: • Mindst 9 timers mellemrum mellem indgivelserne
English: HEMANGIOL should be administered for a 6-month period.
Danish: HEMANGIOL bør administreres i en 6-måneders periode.
English: Rinse the empty syringe after each use into a glass of clean water: 1- Take a glass of clean water
Danish: Skyl den tomme sprøjte efter hver brug i et glas rent vand: 1- Tag et glas rent vand
English: Therefore the need for treatment should be carefully weighed up.
Danish: Derfor bør behovet for behandling nøje overvejes.
English: Propranolol is almost completely absorbed after oral administration.
Danish: Propranolol absorberes næsten fuldstændigt efter oral administration.
English: When treatment was re-initiated, a satisfactory response was observed in a large majority of patients.
Danish: Efter genoptagelse af behandlingen, blev der observeret en tilfredsstillende respons hos størstedelen af patienterne.
English: Combinations should consider the 2 following situations (not mutually exclusive):
Danish: De 2 følgende situationer bør tages op til overvejelse i tilfælde af kombination (udelukker ikke hinanden indbyrdes):
English: Biotransformation and elimination:
Danish: Biotransformation og elimination:
English: • Heart failure not controlled by treatment
Danish: • Hjertefejl som ikke er kontrolleret med behandling
English: Less than 1% of a dose is excreted as unchanged drug in the urine.
Danish: Mindre end 1 % af en dosis udskilles som uændret stof i urinen.
English: • Second- or third-degree atrioventricular blocks
Danish: • Anden- eller tredjegrads-atrioventrikulær blok
English: 11.4% of patients needed to be re-treated after treatment discontinuation.
Danish: 11,4 % af patienterne havde behov for gentaget behandling efter afbrydelse af behandlingen.
English: Based on a retrospective study, a minority of patients (12%) required a re-initiation of systemic treatment.
Danish: Det fremgår af et retrospektivt studie, at et lille antal patienterne (12 %) havde behov for en ny initiering af en systemisk behandling.
English: A monitoring of electrolyte should be performed in these patients.
Danish: Der bør gennemføres en monitorering af elektrolytter hos disse patienter.
English: Do not use any soap or alcohol based product to clean.
Danish: Brug ikke sæbe- eller alkoholbaserede produkter til rengøringen.
English: • lack of partial agonist activity (or intrinsic sympathomimetic activity).
Danish: • mangel på delvis agonist-aktivitet (eller intrinsisk sympatomimetisk aktivitet).
English: Other Central Nervous System disorders were principally observed during the early periods of treatment.
Danish: Andre lidelser i det centrale nervesystem blev hovedsageligt observeret i løbet af de første perioder af behandlingen.