FrancophonIA/ELRC3.0 huggingface dataset:
English: If it is almost time for the next dose you will skip the missed dose and go back to the normal dosage schedule.
Danish: Hvis det næsten er tid for den næste dosis, skal De springe den mistede dosis over, og gå tilbage til det normale dosisprogram.
English: Injections should be rotated between at least four different sites.
Danish: Injektionsstedet bør skifte mellem mindst fire forskellige steder.
English: Some of these side effects may be similar to the effects of surgery.
Danish: Nogle af disse bivirkninger kan ligne bivirkningerne ved kirurgi.
English: Metabolites lacking one or two C-terminal amino acids constitute a minor proportion of the material recovered from urine (<7%).
Danish: Metabolitter, som mangler 1 eller 2 C-terminale aminosyrer udgør en mindre del af det materiale, som genvindes af urinen (< 7 %).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 1997
Danish: Dato for første tilladelse: 9. juli 1997 Dato for seneste fornyelse: 9. juli 2007
English: That activity should be taken into account in the evaluation of the overall coagulation status of the patient during the switch (see section 4.2).
Danish: Der bør tages højde for denne aktivitet, når patientens samlede koagulationsstatus evalueres i løbet af skiftet (se pkt.
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilance-systemet, som er beskrevet i markedsføringstilladelsen , Modul 1.8.1, er på plads og fungerer, før og mens produktet markedsføres.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C when reconstitution has taken place in controlled and validated aseptic conditions.
Danish: Hvis det ikke bruges med det samme, er opbevaringstiderne for det brugsfærdige produkt og omstændighederne før brug, brugerens ansvar og skal normalt ikke være længere end 24 timer ved 2 °C - 8 °C, når der er foretaget rekonstitution under kontrollerede og godkendte, aseptiske omstændigheder.
English: Like all medicines, Revasc can cause side effects, although not everybody gets them.
Danish: Revasc kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000).
Danish: < 1/10); ikke almindelig ≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000).
English: Do not use Revasc if you notice that the solution for injection contains visible particles.
Danish: Anvend ikke Revasc, hvis De bemærker at opløsningen til injektion indeholder synlige partikler.
English: You should also inform your doctor if you have ever received Revasc, hirudin or an hirudin analogue.
Danish: De bør også informere Deres læge, hvis De nogensinde har fået Revasc, hirudin eller hirudinanaloger.
English: This applies to both prescription and non-prescription medicines, especially:
Danish: Dette gælder både receptpligtig og håndkøbsmedicin, især:
English: Cross-sensitivity to other hirudin products is possible.
Danish: Kryds-allergi over for andre hirudinprodukter er mulig.
English: The total and renal clearances of desirudin are slightly reduced in elderly subjects compared to young volunteers.
Danish: Den totale og renale clearance af desirudin er let reduceret hos ældre patienter sammenlignet med yngre frivillige.
English: If necessary, plasma expanders and/or blood transfusion may be used.
Danish: Om nødvendigt kan der indgives plasmasubstitutter og/eller foretages blodtransfusion.
English: Peak aPTT should not exceed twice the control value.
Danish: Maksimum aPPT bør ikke overskride 2 gange kontrolværdien.
English: If you are of a child-bearing age, a pregnancy test may be done by your doctor to make sure you are not
Danish: Hvis De er i den fødedygtige alder, skal der af Deres læge udføres en graviditetsprøve for at sikre, at De ikke er gravid.
English: The most likely side effect is bleeding.
Danish: Den mest sandsynlige bivirkning er blødning.
English: The recommended dose is 15 mg twice daily.
Danish: Den anbefalede dosis er 15 mg to gange om dagen.
English: If this occurs, Revasc will be stopped and treatment given for the bleeding.
Danish: Hvis dette sker, skal Revasc stoppes, og der skal gives behandling for blødningen.
English: In such cases desirudin should be discontinued.
Danish: I sådanne tilfælde bør behandlingen med desirudin afbrydes.
English: Desirudin has no profibrinolytic activity.
Danish: Desirudin har ingen profibrinolytisk aktivitet.
English: * produced by recombinant DNA technology in yeast cells.
Danish: *Fremstillet ved rekombinant DNA teknologi i gærceller.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette lægemiddel ikke blandes med andre præparater.
English: It is advisable not to breast-feed during treatment.
Danish: Det tilrådes ikke at amme under behandlingen.
English: Although fatal reactions have not been reported with desirudin, alternative treatment options must be considered before the decision to re-expose a patient to Revasc.
Danish: Selv om der ikke er blevet rapporteret dødelige reaktioner med desirudin, bør alternative behandlingsmuligheder overvejes før, der tages beslutning om på ny at udsætte en patient for Revasc.
English: As with other anticoagulants, bleeding is the most common adverse reaction.
Danish: Som for andre antikoagulanter er blødning den hyppigst forekommende bivirkning.
English: ** corresponding to approximately 270,000 antithrombin units (ATU) or 18,000 ATU per mg of desirudin with reference to the WHO Second International Standard for alpha-thrombin.
Danish: ** Svarer til ca. 270.000 antitrombinenheder (ATU) eller 18.000 ATU pr. mg desirudin i henhold til WHO Second International Standard for alpha-trombin.
English: This decrease can be considered unlikely to be of clinical significance, thus requiring no dose reduction.
Danish: Faldet har ingen klinisk betydning, hvorfor der ikke kræves dosisreduktion.
English: Administration is by subcutaneous injection, preferably at an abdominal site.
Danish: Administrationen sker ved subkutan injektion, helst abdominalt.
English: The reconstituted solution should be used as soon as possible (see section 6.3 above).
Danish: Den rekonstituerede opløsning bør anvendes så hurtigt som muligt (se pkt.
English: The active substance is rapidly redispersed by shaking gently producing a clear solution.
Danish: Det aktive stof opløses hurtigt ved at ryste hætteglasset let, hvorved der dannes en klar opløsning.
English: If a patient is switched from oral anticoagulants to desirudin therapy or from desirudin to oral anticoagulants, the anticoagulant activity should continue to be closely monitored with appropriate methods.
Danish: Hvis en patient skifter fra oral antikoagulantionsbehandling til behandling med desirudine eller fra desirudin til oral antikoagulanter, bør antikoagulant aktiviteten fortsat nøje monitorers efter passende metoder.
English: There is no antidote for desirudin.
Danish: Der er ingen antidot til desirudin.
English: Reconstitute immediately before use with solvent provided.
Danish: Rekonstitueres umiddelbart før brug med vedlagte solvens.
English: The common name of the active substance in Revasc is desirudin.
Danish: Det almindelige navn på den aktive substans i Revac er desirudin.
English: Revasc is contraindicated in pregnancy (see section 4.3).
Danish: Revasc er kontraindiceret under graviditet (se pkt.
English: It is often given for several days after operations because blood clots are most likely to form when you are resting in bed.
Danish: Revasc gives ofte i flere dage efter operationer, da dannelsen af blodpropper er mest sandsynlig, når man er sengeliggende.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: De ikke-kliniske data viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet og karcinogenicitet..
English: - with severe uncontrolled hypertension and subacute bacterial endocarditis.
Danish: 4.6), - alvorlig ukontrolleret hypertension og ved subakut bakteriel endocarditis.
English: Hepatic elimination of desirudin or the thrombindesirudin complex does not appear to be significant.
Danish: Hepatisk elimination af desirudin eller trombin-desirudin komplekset synes ikke at være væsentlig.
English: Desirudin belongs to a group of medicines called anticoagulants, which prevent blood clots from forming in the blood vessels.
Danish: Desirudin tilhører en gruppe lægemidler kaldet antikoagulanter, som forhindrer, at der dannes blodpropper i blodårerne.
English: The concomitant use of desirudin with thrombolytics and ticlopidine has not been investigated in this patient population.
Danish: Samtidig brug af desirudin med trombolytika og ticlopidin er endnu ikke blevet undersøgt i denne patientpopulation.
English: Desirudin is a highly potent and selective inhibitor of free circulating and clot-bound thrombin.
Danish: Desirudin er en yderst potent og selektiv hæmmer af frit cirkulerende og koagelbundet trombin.
English: Powder: magnesium chloride, sodium hydroxide Solvent: mannitol, water for injections
Danish: Pulver: magnesiumchlorid, natriumhydroxid Solvens: mannitol, vand til injektionsvæske
English: EU/1/97/043/002 10 vials/10 ampoules of solvent EU/1/97/043/003 1 vial/1 ampoule of solvent
Danish: EU/1/97/043/001 2 hætteglas/2 ampuller med solvens EU/1/97/043/002 10 hætteglas/10 ampuller med solvens EU/1/97/043/003 1 hætteglas/1 ampul med solvens
English: The anticoagulant effect of desirudin is poorly reversible.
Danish: Den antikoagulerende effekt af desirudin er ikke særlig reversibel.
English: There are no adequate data from the use of desirudin in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brugen af desidurin hos gravide kvinder.
English: Overdose with Revasc may lead to bleeding.
Danish: Overdosering af Revasc kan medføre blødning.
English: The other ingredients in the powder are magnesium chloride and sodium hydroxide.
Danish: - Øvrige indholdsstoffer i pulveret: magnesiumchlorid og natriumhydroxid.
English: Treatment initiation with Revasc should be undertaken only in a setting where medical assistance is readily available and where there is access to treatment for anaphylactic reactions.
Danish: Iværksættelse af behandling med Revasc bør kun ske på steder, hvor hurtig medicinsk assistance er tilstede, og hvor der er adgang til behandling af anafylaktiske reaktioner.
English: In vitro and in vivo animal data indicate that desirudin is for the most part eliminated and metabolised by the kidney.
Danish: In vitro og in vivo data fra dyr indikerer, at desirudin fortrinsvis elimineres og metaboliseres i nyrerne.
English: During prophylaxis, concomitant use of medicinal products containing heparins (unfractionated and low-molecular weight heparins) and dextrans is not recommended.
Danish: Ved profylakse kan samtidig brug af lægemidler, der indeholder hepariner (ikke-fraktionerede og lavmolekylære hepariner) og dextraner ikke anbefales.
English: Any unused product or waste material should be disposed in accordance with local requirements.
Danish: Ikke anvendt produkt eller spil, bør bortskaffes ifølge de lokale regler.
English: The following related adverse reactions were listed below by system organ class and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness: common (≥
Danish: De følgende relaterede bivirkninger er listet nedenfor efter systemorganklasser og inden for hver enkelt frekvensgruppering skal bivirkningerne opstilles efter faldende alvor: Almindelig (≥ 1/100 til
English: Mean absorption time of subcutaneous (SC) desirudin is 4.1, 4.5 and 5.4 h for dose levels of 0.1, 0.3 and 0.5 mg/kg, respectively (overall mean = 4.6 h).
Danish: Den gennemsnitlige absorptionstid for subkutan (s.c.) desirudin er 4,1, 4,5 og 5,4 timer ved henholdsvis 0,1, 0,3 og 0,5 mg/kg (total middelværdi = 4,6 timer).
English: Do not use reconstituted vials containing visible particles.
Danish: Anvend ikke færdigblandede hætteglas som indeholder synlige partikler.
English: The usual dosage is 15mg injected twice a day for 9 days to a maximum of 12 days.
Danish: Den normale dosis er 15 mg injiceret to gange daglig i 9 til højst 12 dage.
English: Reproductive toxicology studies in animals showed desirudin to be teratogenic with changes comprising spina bifida in rabbits and omphaloceles in rats.
Danish: Reproduktionstoksikologiske studier hos dyr viste, at desidurin er teratogent med forandringer, der omfatter spina bifida hos kaniner og omfalocele hos rotter.
English: Important information about some of the ingredients of Revasc This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially ‘sodium
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Revasc Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 0,5 ml, dvs. det er i alt væsentligt ”natriumfrit”.
English: Blood and the lymphatic system disorders Common:
Danish: Blod- og lymfesystem Almindelig:
English: After reconstitution, immediate use is recommended.
Danish: Efter rekonstitution anbefales det at anvende produktet straks.
English: There is no experience in children.
Danish: Der er ingen erfaring med behandling af børn.
English: Desirudin should be used with care in patients receiving anticoagulants, and/or platelet inhibitors, and/or non-steroidal anti-inflammatory medicinal products.
Danish: Desirudin bør anvendes med forsigtighed til patienter, som får antikoagulantia, og/eller thrombocythæmmere, og/eller non steroid antiinflammatoriske lægemidler.
English: Overdosage of desirudin could lead to bleeding complications.
Danish: Overdosis af desirudin kan medføre blødningskomplikationer.
English: Desirudin should not be administered by intramuscular injection owing to the risk of local
Danish: Desirudin bør ikke gives intramuskulært på grund af risiko for lokalt hæmatom.
English: Monitoring for evidence of bleeding is advised (see section 4.5).
Danish: Kontrol for tegn på blødninger tilrådes (se pkt.
English: There is no experience with Revasc in children.
Danish: Børn Der er ingen erfaring med Revasc til børn.
English: Laboratory Tests: Activated partial thromboplastin time (aPTT) should be monitored in patients with increased risk of bleeding and/or renal or hepatic impairment.
Danish: Laboratorieprøver: Aktiveret partiel tromboplastintid (aPPT) bør monitorers hos patienter med øget risiko for blødningskomplikationer og/eller nedsat nyre- eller leverfunktion.
English: The anticoagulant properties of desirudin are demonstrated by its ability to prolong the clotting time of human or rat plasma whether induced directly (thrombin time) or via the intrinsic (aPTT) or extrinsic (PT) pathways.
Danish: Desirudins antikoagulerende egenskaber skyldes dets evne til at forlænge koagulationstiden i menneske- eller rotteplasma, hvad enten det er en direkte effekt (TT) eller via det intrinsikke (aPTT) eller ekstrinsikke (PT) system.
English: When desirudin is administered in patients with increased risk of bleeding complications, mild to moderate hepatic dysfunction and/or mild to moderate renal impairment, aPTT should be monitored and peak aPTT should not exceed twice the control value.
Danish: Når desirudin administreres til patienter med øget risiko for blødningskomplikationer, let til moderat nedsat leverfunktion og/eller let til moderat nedsat nyrefunktion bør aPPT monitoreres og maksimum aPTT bør ikke overskride 2 gange kontrolværdien.
English: Fatal anaphylactic reactions have been reported in patients re-exposed to hirudin product therapy in a second or subsequent treatment course.
Danish: Livsfarlige anafylaktiske reaktioner er rapporteret hos patienter, der gentagne gange har fået behandling med hirudin-produkter i andet eller efterfølgende behandlingsforløb.
English: Anaphylaxis: Revasc may cause allergic reactions including anaphylaxis and shock (see section 4.8).
Danish: Anafylaksi: Revasc kan medføre allergiske reaktioner inklusive anafylaksi og shock (se pkt.
English: Desirudin is contraindicated in patients with severe renal impairment (creatinine clearance of less than 30ml/min corresponding to a serum creatinine > 2.5mg/dl or 221μmol/l; see section 4.3).
Danish: Desirudin er kontraindiceret hos patienter med svært nedsat nyrefunktion (kreatininclearence mindre end 30 ml/min svarende til serumkreatinin > 2,5 mg/dl eller 221µmol/l); se pkt.
English: 4.2 Posology and method of administration Treatment with Revasc should be initiated under the guidance of a physician with experience in coagulation disorders.
Danish: Behandling med Revasc bør påbegyndes under vejledning af en læge med erfaring inden for koagulationsforstyrrelser.
English: Common reported side effects (likely to affect between 1 in 10 and 1 in 100 patients):
Danish: Almindeligt indberettede bivirkninger (rammer sandsynligvis mellem 1 ud af 10 og 1 ud af 100 patienter):
English: Instructions for the preparation of Revasc are provided in section 6.6.
Danish: Vejledning i tilberedning af Revasc er anført under pkt.
English: Anti-hirudin antibodies have been detected upon re-exposure to desirudin in
Danish: Anti-hirudin antistoffer er fundet efter reeksponering for desirudin i kliniske
English: Desirudin is distributed in the extracellular space with a distribution volume at steady state of 0.251/kg independently of the dose.
Danish: Desirudin fordeles ekstracellulært med et fordelingsvolumen ved steady state på 0,25 l/kg, uafhængig af dosis.
English: At therapeutic serum concentrations it has no effect on other enzymes of the haemostatic system such as factors IXa, Xa, kallikrein, plasmin, tPA, or activated protein C. In addition, it does not display any effect on other serine proteases, such as the digestive enzymes trypsin or chymotrypsin, or on complement activation by the classical or
Danish: Der er ved terapeutiske serumkoncentrationer ingen effekt på de andre enzymer i det hæmostatiske system såsom faktorerne IXa, Xa, kallikrein, plasmin, tPA og aktiveret protein C. Herudover er der ikke effekt på andre serinproteaser, såsom fordøjelsesenzymerne trypsin og kymotrypsin eller på komplementaktivering ad klassiske eller alternative veje.
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, nurse or pharmacist.
Danish: Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De oplyse Deres læge, sygeplejerske eller apotek herom.
English: - medicines used to prevent blood-clotting (warfarin, heparin and dicoumarol) - medicines which affect the function of platelets (particles in the blood involved in bloodclotting), e.g. acetylsalicylic acid, a substance present in many medicinal products used to relieve pain and lower fever, and other non-steroidal anti-inflammatory agents.
Danish: - medicin, der forebygger dannelse af blodpropper (warfarin, heparin og dikumarol) - medicin, som påvirker blodpladernes funktion (partikler i blodet, som er involveret i blodets størkning), f.eks. acetylsalicylsyre, et stof, som findes i mange medicinske produkter, der anvendes til at lindre smerte og nedsætte feber samt andre non-steroide antiinflammatoriske
English: In post-marketing surveillance, rare reports of major haemorrhages, some of which were fatal; and rare reports of non-fatal anaphylactic or anaphylactoid reactions leading to shock have been received.
Danish: I overvågning efter markedsføring er der en sjælden gang modtaget rapporter om tilfælde af større blødninger, hvoraf nogle var med dødelig udgang og sjældne rapporter om ikke dødelige anafylaktiske eller anafylaktoide reaktioner, som medførte shock.
English: The first injection should be initiated 5 to 15 minutes before surgery but after induction of regional block anaesthesia, if used.
Danish: Den første injektion bør indledes 5-15 minutter før operation, men efter anlæggelse af lokalbedøvelse, såfremt dette benyttes.
English: If any of the above apply to you, the doctor or nurse will monitor your blood for clotting activity and may change your dose or dosing schedule accordingly.
Danish: Hvis noget af ovenstående passer på Dem, vil lægen eller sygeplejersken undersøge Deres blod for størkningsaktivitet og eventuelt ændre Deres dosis i henhold hertil.
English: Rare side effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients): Anti-hirudin antibodies have been detected upon re-exposure Isolated cases of fatal bleeding have been reported.
Danish: Sjældne bivirkninger (rammer sandsynligvis mellem 1 ud af 1.000 og 1 ud af 10.000 patienter): Der er blevet målt anti-hirudin antistoffer ved gentagen indgift.
English: Desirudin is a recombinant DNA product derived from yeast cells.
Danish: Desirudin er et genmanipuleret DNA-produkt udvundet fra gærceller.
English: Currently, there is no clinical experience to support the use of Revasc
Danish: Der er i øjeblikket ingen klinisk erfaring, der støtter brug af Revasc i mere end 12 dage.
English: Increase in serum transaminases
Danish: Undersøgelser Ikke almindelig: Stigning i serumtransaminaser
English: The active substance is desirudin (15mg/0.5ml powder).
Danish: Revasc indeholder - Aktivt stof: desirudin (15 mg/05 ml pulver).
English: Revasc is used to prevent blood clotting after elective hip or knee replacement surgery, as harmful blood clots can form in the blood vessels of the legs.
Danish: Revasc bruges til at forhindre dannelsen af blodpropper efter planlagte hofte- og knæudskiftnings operationer, da der kan dannes skadelige blodpropper i benenes blodårer.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 15 mg desirudin.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 hætteglas indeholder 15 mg desirudin.
English: Any agent which may enhance the risk of haemorrhage should be discontinued prior to initiation of desirudin therapy.
Danish: Alle lægemidler, som kan øge risikoen for blødning, bør seponeres inden starten på behandling med desirudin.
English: The disappearance of desirudin from plasma is rapid in the first phase with approximately 90% of an intravenous (IV) bolus dose disappearing from the circulation within 2 hours of the injection.
Danish: Udskillelsen af desirudin fra plasma er hurtig, således udskilles ca. 90 % af en intravenøs bolusinjektion i løbet af 2 timer.
English: It is not known whether desirudin is excreted in human milk.
Danish: Det vides ikke om desirudin udskilles via modermælken.
English: What Revasc is and what it is used for
Danish: REVASCS VIRKNING OG HVAD DE SKAL BRUGE DET TIL
English: After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges.
Danish: Efter rekonstitution indeholder 1 hætteglas 15 mg** desirudin* per 0,5ml Desirudin består af et enkeltkædet polypeptid af 65 aminosyrerester og 3 disulfid-bindinger.
English: To date clinical data are available on hip surgery
Danish: Indtil videre er kliniske data kun tilgængelige på hoftekirugi.
English: Following administration of single SC doses of 0.1-0.75 mg/kg, plasma concentrations of desirudin increased rapidly to maximum levels (Cmax) between 1 and 3 h. Both Cmax and AUC values are dose
Danish: Efter administrationen af en s.c. enkeltdosis på 0,1 - 0,75 mg/kg stiger plasmakoncentrationen af desirudin hurtigt til maksimumniveauer (Cmax) i løbet af 1-3 timer.