FrancophonIA/ELRC3.0 huggingface dataset:
English: - In general, an infusion rate of 0.21 mg/kg/hour should not be exceeded without checking for coagulation abnormalities which might be preventing an appropriate aPTT response.
Danish: - Generelt bør en infusionshastighed på 0,21 mg/kg/t ikke overstiges uden at undersøge om der er koagulationsanormaliteter, som muligvis forhindrer en passende APPT respons.
English: In patients with a body weight exceeding 110 kg the dosage should not be increased beyond the 110 kg body weight dose (see also tables 2 and 3, below).
Danish: Hos patienter, der vejer over 110 kg, bør dosis ikke øges mere end svarende til 110 kg legemsvægt (se tabel 2 og 3, herunder).
English: Severe bleeding may lead to decreased volume of circulating blood, low blood pressure, shock, and their clinical sequelae.
Danish: Alvorlig blødning kan føre til mindre volumen af cirkulerende blod, lavt blodtryk, chok, og disses kliniske symptomer.
English: The parenteral agent can be discontinued when the International Normalised Ratio (INR) stabilises within the desired target range.
Danish: Behandling med det parenterale middel kan indstilles, når INR (International Normalised Ratio) er stabiliseret inden for det ønskede område.
English: Mutagenicity Lepirudin was not mutagenic or clastogenic in standard assays for such effects.
Danish: Mutagenicitet Lepirudin var ikke mutagent eller klastogent i standardiserede assays for sådanne effekter.
English: Distribution is essentially confined to extra-cellular fluids and is characterised by an initial half-life of approximately 10 minutes.
Danish: Fordelingen er langt overvejende begrænset til ekstracellulærvæsken og karakteriseres ved en initial halveringstid på ca. 10 minutter.
English: Elimination follows a first order process and is characterised by a terminal half-life of about 1.3 hours in young healthy volunteers.
Danish: Eliminationen følger første ordens kinetik og karakteriseres ved en terminal halveringstid på ca. 1,3 timer hos unge og raske frivillige forsøgs-personer.
English: Monitoring: - In general, the dosage (infusion rate) should be adjusted to the activated partial thromboplastin time, aPTT.
Danish: Monitorering: - Dosis (infusionshastighed) bør sædvanligvis justeres i henhold til aktiveret partiel tromboplastin-tid, APTT.
English: Intravenous infusion:
Danish: Intravenøs infusion:
English: Reconstitute the lyophilisate as described in section 6.6.
Danish: Injektions-/infusionssubstansen rekonstitueres som beskrevet i afsnit 6.6.
English: In female patients the systemic clearance is about 25 % lower as compared to male patients.
Danish: Hos kvindelige patienter er den systemiske clearance ca. 25 % lavere end hos mandlige patienter.
English: In the indication HIT type II with thromboembolic disease (125 patients) the overall mortality during the study period was approximately 9 % while amputations and new thromboembolic complications were recorded in 6 % and 10 %, respectively.
Danish: Ved indikationen type II HIT med thromboembolisk sygdom (125 patienter) var den totale mortalitet under hele studiet ca. 9 %, medens amputationer og thromboemboliske komplikationer blev registreret i henholdsvis 6 % og 10 % af patienterne.
English: - Patients should be informed that they have received Refludan.
Danish: - Patienten bør informeres om, at han/hun er blevet behandlet med Refludan.
English: - Formation of anti-hirudin antibodies was observed in about 40 % of HIT type II patients and have been reported especially with a treatment period exceeding five days.
Danish: - Dannelse af anti-hirudin antistoffer observeredes hos ca. 40 % af patienterne med type II HIT og blev rapporteret specielt i tilfælde med behandlingsperiode på mere end fem dage.
English: Life-threatening bleeding events (including intracranial bleeding) were uncommonly reported (≥1/1,000 to <1/100) in patients with acute coronary syndrome included in clinical studies.
Danish: Livstruende blødningshændelser (inklusive intrakraniel blødning) blev rapporteret som ikke almindelige (≥1/1,000 til <1/100) hos patienter med akut koronar syndrom, der var inkluderet i kliniske studier.
English: In a standard embryo-foetal toxicity trial, decreased pup and maternal survival was observed.
Danish: I en standardiseret embryo-føtal toxicitetstest observeredes nedsat overlevelse hos unger og mater.
English: Its activity is measured in a chromogenic assay.
Danish: Dets aktivitet måles i et kromogent assay.
English: It constitutes a certain kind of allergy towards heparin.
Danish: Tilstanden skyldes en slags allergi overfor heparin.
English: After reconstitution: use immediately.
Danish: Efter rekonstitution: anvendes øjeblikkelig
English: It may be necessary to exclude patients with renal impairment from treatment with lepirudin regimen.
Danish: Det kan blive nødvendigt at patienter med nedsat nyrefunktion ekskluderes fra behandling med lepirudin regimen.
English: Like all medicines, Refludan can have side effects, although not everybody gets them.
Danish: Refludan kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Dose modifications: - Any aPTT value out of the target range is to be confirmed at once before drawing conclusions with respect to dose modifications, unless there is a clinical need to react immediately.
Danish: Dosisjustering: - Enhver APTT-værdi uden for målintervallet bør straks bekræftes, før der drages konklusioner med hensyn til justering af dosis, medmindre det er klinisk nødvendigt at handle øjeblikkeligt.
English: In case of overdose the risk of bleeding may be increased.
Danish: Ved overdosering kan blødningsrisikoen være øget.
English: Currently, no specific antidote against lepirudin is available.
Danish: En specifik antidot mod lepirudin er i øjeblikket ikke tilgængelig.
English: Anaphylactic/oid reactions
Danish: Anafylaktiske/oide reaktioner
English: Do not use solutions which are cloudy or contain particles.
Danish: Anvend ikke opløsninger, der er uklare eller indeholder partikler.
English: Results from studies in pigs showed that the application of von Willebrand Factor (vWF, 66 I.U./kg body weight) markedly reduced the bleeding time.
Danish: Undersøgelser på grise viser, at applikation af von Willebrand Factor (WF, 66 IE/kg legemsvægt.)
English: Lepirudin is a highly specific direct inhibitor of thrombin.
Danish: Lepirudin er en meget specifik direkte thrombin-inhibitor.
English: The clinical information on HIT type II in this SPC is based upon the data of two prospective trials comprising a total of 198 HIT type II patients treated with Refludan.
Danish: Den kliniske information om type II HIT er i dette produktresumé baseret på data fra 2 prospektive kliniske afprøvninger, som i alt omfatter 198 type II HIT-patienter, der er behandlet med Refludan.
English: The pharmacokinetic properties of lepirudin following intravenous administration are well described by a two-compartment model.
Danish: Lepirudins farmakokinetiske egenskaber efter intravenøs administration beskrives tilfredsstillende som en to-kompartment model.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis nogen af bivirkninger bliver alvorlige, eller De bemærker bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De oplyse Deres læge eller apotek herom.
English: Treatment initiation with Refludan should be undertaken only in a setting where medical assistance is readily available and where there is access to treatment for anaphylactic reactions.
Danish: Behandling med Refludan bør kun startes op i et miljø, hvor medicinsk hjælp er hurtig tilgængelig, og hvor der er adgang til behandling for anafylaktiske reaktioner.
English: In all other cases the dose adjustment is based on the creatinine value.
Danish: I alle andre tilfælde baseres dosisjusteringen på S-kreatinin.
English: Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu
English: It may result in a too low number of blood platelets and/or clots in your blood vessels (thrombosis).
Danish: Sygdommen kan medføre for lavt antal blodplader og/eller blodpropper i Deres blodkar (tromboser).
English: HIT type II is an illness which can occur after you have received heparin containing medicines.
Danish: Type II HIT er en sygdom, der kan opstå efter behandling med heparin-holdige lægemidler.
English: Pharmacotherapeutic group: Antithrombotic agent - direct thrombin inhibitor, ATC Code: B01AE02
Danish: Farmakoterapeutisk klassifikation: Antithrombosemiddel - direkte thrombininhibitor (ATC-kode: B01AE02)
English: - There is no experience with lepirudin in patients with significant liver impairment.
Danish: - Der er ingen erfaring med lepirudin til patienter med signifikant leverskade.
English: This may additionally lead to deposition of clots in organs.
Danish: Dette kan desuden føre til aflejring af blodpropper i andre organer.
English: In any case, the bolus dose must be reduced to 0.2 mg / kg body weight.
Danish: I alle tilfælde bør bolusdosis reduceres til 0,2 mg / kg legemsvægt.
English: One anti-thrombin unit (ATU) is the amount of hirudin that neutralises one unit of WHO preparation 89/588 of thrombin.
Danish: 1 antithrombin-enhed (ATU) er den mængde hirudin, som neutraliserer 1 enhed af WHO-thrombinstandard 89/588.
English: Instructions for use and handling:
Danish: Instruktioner vedrørende anvendelse, håndtering samt bortskaffelse:
English: The following dosage recommendations are based on single-dose studies in a small number of patients with renal impairment.
Danish: De følgende dosisrekommendationer er baseret på enkelt-dosisundersøgelser på et mindre antal patienter med nedsat nyrefunktion.
English: - If the confirmed aPTT value is below the target range, the infusion speed should be increased by 20 %.
Danish: - Såfremt det bekræftes, at APTT ligger under målintervallet, bør infusionshastigheden øges med 20 %.
English: Where there is active bleeding or bleeding tendency it is generally not advisable to administer Refludan.
Danish: Ved aktiv blødning eller blødningstendens kan det normalt ikke anbefales at anvende Refludan.
English: More frequent determinations may be necessary, for example, in patients with renal impairment or with an increased risk of bleeding.
Danish: Mere hyppige bestemmelser kan blive nødvendige, fx hos patienter med nedsat nyrefunktion eller med forøgede risiko for blødning.
English: You should also inform your doctor if you have ever received Refludan, hirudin or a hirudin analogue.
Danish: Du bør også fortælle din læge, om du tidligere er blevet behandlet med Refludan, hirudin eller et hirudin-lignende produkt.
English: Additionally, individual case reports and in-vitro data suggest that either haemofiltration or haemodialysis (using high flux dialysis membranes with a cut-off point of 50,000 Dalton) may be useful in this situation.
Danish: Enkeltpatient-rapporter og in-vitro data tyder på, at enten hæmofiltration eller hæmodialyse (her anvendes high flux dialysemembraner med et “cut-off point” på 50.000 Dalton) kan være nyttig i denne situation.
English: Table 1: Reduction of infusion rate in patients with renal impairment
Danish: Tabel 1: Reduktion af infusionshastighed hos patienter med nedsat nyrefunktion
English: Antibodies against hirudin which appeared in several of the treated monkeys resulted in prolongation of the terminal half-life and an increase in systemic exposure to lepirudin.
Danish: Antistoffer mod hirudin, hvilket sås hos flere af de behandlede aber, resulterede i en forlængelse af den terminale halveringstid og en øgning i den systemiske eksponering for lepirudin.
English: No evidence of a neutralisation of lepirudin or of an allergic reaction associated with the positive antibody test results was found.
Danish: Der fandtes ikke tegn på neutralisation af lepirudin eller på en allergisk reaktion associeret med det positive antistoffund.
English: - If the confirmed aPTT value is above the target range, the infusion should be stopped for two hours.
Danish: - Såfremt det bekræftes, at APTT ligger over målintervallet, bør infusionen afbrydes i 2 timer.
English: Do not use Refludan after the expiry date which is stated on the carton and the vial after EXP.
Danish: Må ikke anvendes efter den udløbsdato, som er angivet på æsken og hætteglasset
English: Rare (less than 1 in 1,000 people affected) - Allergic skin reactions (including rash), itching, hot flushes, fever, chills.
Danish: Sjældne (mindre end 1 ud af 1000 patienter påvirkes) Allergiske hudreaktioner (inklusive udslæt), kløe, hedeture, feber, kuldegysninger.
English: Platelet factor 4 does not inhibit lepirudin.
Danish: Blodpladefaktor 4 hæmmer ikke lepirudin.
English: Single and repeat-dose toxicity studies in mice, rats and monkeys showed the adverse responses that could be expected from an exaggerated pharmacodynamic impact of lepirudin.
Danish: Enkeltdoser og gentagne doser anvendt i toxicitetsstudier på mus, rotter og aber påviste de uønskede virkninger, som kunne forventes ud fra en overdreven kraftig farmakodynamisk effekt af lepirudin.
English: With respect to lepirudin dosage the potential of renal impairment in elderly patients is to be taken into account.
Danish: Med hensyn til lepirudin dosis, skal der tages højde for mulig nedsat nyrefunktion hos ældre patienter.
English: Additional aPTT monitoring is mandatory.
Danish: Ekstra APTT-måling er obligatorisk.
English: - Mannitol - Sodium hydroxide for adjustment to pH 7
Danish: - Mannitol - Natriumhydroxid, justering til pH 7
English: To avoid prothrombotic effects when initiating coumarin, continue parenteral anticoagulation for 4 to 5 days (see oral anticoagulant package insert for information).
Danish: For at undgå protrombotisk effekt i begyndelsen af coumarinbehandlingen, bør parenteral antikoagulationsbehandling forsættes i 4-5 dage (se indlægsseddel for oralt antikoagulerende middel).
English: Treatment with Refludan should be initiated under the guidance of a physician with experience in coagulation disorders.
Danish: Behandling med Refludan bør kun sættes i gang under vejledning af en læge med særligt kendskab til koagulationssygdomme.
English: In patients with terminal renal insufficiency prolonged elimination half-lives of about 2 days were observed.
Danish: Hos patienter med terminal nyreinsufficiens fandtes en forlænget terminal halveringstid på ca. 2 døgn.
English: - With other reagents, the upper limit of the therapeutic aPTT window should be reduced to 2.5 fold prolongation of the normal control value.
Danish: - Med andre reagenser skal den øvre grænse for det terapeutiske APTT-vindue reduceres til 2,5 gange forlængelse af den normale kontrolværdi.
English: Colourless glass vial (glass type I) sealed with bromobutyl rubber infusion stopper, plastic flip-off cap and aluminium cap.
Danish: Farveløst glasbeholder (glas type I) lukket med bromobutyl gummiprop, plast flip-off låg og aluminiumshætte.
English: This may result in an enhanced anticoagulant effect of lepirudin, possibly due to delayed renal elimination of active lepirudin-antihirudin complexes.
Danish: Dette kan resultere i en øget antikoagulerende virkning af lepirudin muligvis på grund af forsinket nyre udskillelse af aktive lepirudi-antihirudin komplekser.
English: The physician should carefully weigh the risk of Refludan administration versus its anticipated benefit, taking into account possible measures to control bleeding.
Danish: Lægen skal nøje afveje risikoen ved Refludan-administration mod de forventede fordele samtidig med at lægen tager højde for mulige metoder for at kontrollere blødning.
English: Liver cirrhosis may also affect the renal excretion of lepirudin.
Danish: Lever cirrhosis kan også have effekt på den renale udskillelse af lepirudin.
English: Whenever available, dose adjustments should be based on creatinine clearance values as obtained from a reliable method (24 h urine sampling).
Danish: Justering af dosis bør, når det er muligt, baseres på kreatininclearance målt ved en pålidelig metode (24 timers urinopsamling).
English: The systemic clearance of lepirudin decreases in proportion to the existing glomerular filtration rate.
Danish: Lepirudins systemiske clearance falder proportionalt med den glomerulære filtrationshastighed.
English: - Experience of combined therapy with thrombolytic agents in patients with HIT type II is very limited.
Danish: - Erfaring med kombinationsbehandling med trombolytika til patienter med type II HIT er meget begrænset.
English: Take special care with Refludan:
Danish: Vær ekstra forsigtig med at tage Refludan:
English: Fatal anaphylactic reactions have been reported in patients re-exposed to Refludan in a second or subsequent treatment course.
Danish: Fatale anafylaktiske reaktioner er indberettet hos patienter, der er genbehandlet med Refludan en eller flere gange.
English: Therefore, the treating physician should carefully weigh the risk of administration versus its anticipated benefit.
Danish: Derfor er det nødvendigt at den behandlende læge nøje vurderer og overvejer risikoen ved administration kontra dens forventede fordel.
English: Skin and Subcutaneous Tissue Disorders
Danish: Lidelser i hud og subkutant væv
English: If a patient is scheduled to receive coumarin derivatives (vitamin K antagonists) for oral anticoagulation after Refludan therapy, the following should apply: Coumarin derivatives should be initiated only when platelet counts are normalising.
Danish: Hvis det er planlagt, at en patient skal behandles med et coumarinderivat (vitamin K antagonister) som peroral antikoagulation efter Refludanbehandlingen, gælder følgende: Behandling med coumarinderivater bør kun påbegyndes, når trombocyttallet er normaliseret.
English: Recommendations for use in patients scheduled for a switch to oral anticoagulation
Danish: Anbefalinger vedrørende anvendelse hos patienter, hvor en omstilling til peroral antikoagulation er planlagt
English: Moreover, in rats slight to moderate sinushistiocytosis of the regional lymph nodes and decreased haemosiderin deposits in the spleen were observed.
Danish: Endvidere sås let til moderat sinushistiocytose i de regionale lymfeknuder og fald i hæmosiderindepoterne i milten hos rotter.
English: - Anaphylaxis: Refludan may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Danish: - Anafylaksi: Refludan kan fremkalde allergiske reaktioner inklusive anafylaksi og chok (se pkt.
English: Recommendations for use in patients with renal impairment
Danish: Anbefalinger vedrørende anvendelse hos patienter med nedsat nyrefunktion
English: Antithrombotics are medicines to prevent formation of blood clots (thrombosis).
Danish: Antithrombotiske lægemidler er lægemidler der hæmmer blodpladedannelse (trombosis).
English: One molecule of hirudin binds to one molecule of thrombin and thereby blocks the thrombogenic activity of thrombin.
Danish: Ét lepirudin-molekyle bindes til ét thrombin-molekyle og blokerer herved thrombins thrombogene aktivitet.
English: Lepirudin ([Leu1, Thr2]-63-desulfohirudin) is a recombinant hirudin derived from yeast cells.
Danish: Lepirudin ([Leu1, Thr2]-63-desulfohirudin] er et rekombinant hirudin fremstillet i gærceller.
English: Dosing adjustments are based on renal function, weight, and aPTT (see section 4.2).
Danish: Dosisjusteringer skal foretages på basis af nyre funktion, vægt og APPT (se pkt.
English: In clinical trials, Refludan was not therapeutically administered to HIT type II patients with significant renal impairment.
Danish: I kliniske forsøg er Refludan ikke blevet anvendt terapeutisk til type II HIT-patienter med væsentlig nedsat nyrefunktion.
English: 3 minutes.
Danish: minutter.
English: If life-threatening bleeding occurs and excessive plasma levels of lepirudin are suspected, the following recommendations should be followed: - Immediately STOP Refludan administration - Determine aPTT and other coagulation parameters as appropriate - Determine haemoglobin and prepare for blood transfusion - Follow the current guidelines for shock-therapy.
Danish: Ved livstruende blødning og mistanke om for højt plasma-lepirudin bør følgende retningslinjer følges: - AFBRYD øjeblikkelig Refludanbehandlingen - Bestem APTT og andre relevante koagulationsparametre - Bestem hæmoglobin og gør klar til blodtransfusion - Følg den gældende instruks for behandling af shock.
English: Anemia or drop in the haemoglobin value without obvious source of bleeding Haematoma
Danish: Anæmi eller fald i hæmoglobinværdi uden tydelig blødningskilde Hæmatom
English: - The first aPTT determination should be done 4 hours after start of Refludan therapy.
Danish: - Den første APTT-bestemmelse skal laves 4 timer efter Refludanbehandlingens start.
English: Also contains: mannitol, sodium hydroxide.
Danish: Indeholder også: mannitol, natriumhydroxid.
English: Serious liver injury (e.g. liver cirrhosis) may enhance the anticoagulant effect of lepirudin due to coagulation defects secondary to reduced generation of vitamin K-dependent coagulation factors.
Danish: Svær leverskade (fx lever cirrhosis) kan forøge antikogulationseffekten af lepirudin på grund af koagulationsdefekter sekundært til nedsat udvikling af vitamin K-afhængige koagulationsfaktorer.
English: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
Danish: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Tyskland
English: Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom
Danish: Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, Storbritannien.
English: Marketing Authorisation Holder Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom.
Danish: Indehaver af markedsføringstilladelsen Celgene Europe Ltd., 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, Storbritannien.
English: General toxicity
Danish: Generel toksikologi
English: Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Danish: Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: Table 3: Examples for standard infusion speed according to body weight
Danish: Tabel 3: Eksempler på standardinfusionshastighed i forhold til legemsvægten
English: Concomitant treatment with coumarin derivatives (vitamin K antagonists) and drugs that affect platelet function may also increase the risk of bleeding.
Danish: Samtidig behandling med coumarinderivater (vitamin K antagonister) og medicin som påvirker funktionen af blodplade antallet kan også øge risikoen for blødningsepisoder.
English: Allergic Skin Reactions (including rash) Pruritus
Danish: Allergiske hudreaktioner (inklusive udslæt) Kløe
English: Table 2: Examples for standard injection volume according to body weight
Danish: Tabel 2: Eksempler på standardinjektionsvolumen i forhold til legemsvægten
English: Refludan, once reconstituted with an appropriate solvent, will be administered into a vein, by injection and then by infusion.
Danish: Når Refludan er opløst med en passende opløsningsvæske, vil opløsningen blive givet i en vene ved injektion og derefter ved infusion.
English: Concomitant treatment with thrombolytics (e.g. rt-PA or streptokinase) may - increase the risk of bleeding complications - considerably enhance the effect of Refludan on aPTT prolongation.
Danish: Samtidig behandling med thrombolytika (fx rt-PA eller streptokinase) kan: - øge risikoen for blødningskomplikationer - i betydelig grad potensere Refludans virkning på APTT forlængelsen.
English: In this leaflet:
Danish: Refludan indeholder:
English: The other ingredients are mannitol (E421) and sodium hydroxide for pH adjustment.
Danish: Øvrige indholdsstoffer: mannitol (E421) og natriumhydroxid til justering af PH.