FrancophonIA/ELRC3.0 huggingface dataset:
English: There is a also a theoretical possibility that you could develop antibodies to the proteins in EVARREST, which could potentially interfere with blood clotting.
Danish: Der er også en teoretisk mulighed for, at du kan udvikle antistoffer mod proteinerne i EVARREST, hvilket kunne forstyrre blodstørkningen.
English: EVARREST must be kept dry at all times prior to application to avoid pre-activation.
Danish: EVARREST skal til enhver tid holdes tørt før brug for at forebygge for tidlig aktivering.
English: Do not use after the expiry date stated on the carton and label.
Danish: Må ikke anvendes efter den udløbsdato, der er angivet på æsken og etiketten.
English: Data from eight clinical trials with EVARREST have been pooled into an integrated dataset and the frequencies of occurrence described in the table below originate from this integrated dataset.
Danish: Data fra otte kliniske forsøg med EVARREST er blevet slået sammen til et integreret datasæt, og de hyppigheder, der er beskrevet i nedenstående tabel, stammer fra dette integrerede datasæt.
English: The following adverse events which occurred during clinical studies were considered to be related to the use of EVARREST:
Danish: Følgende bivirkninger, der er forekommet under kliniske forsøg, mentes at være forbundet med brugen af EVARREST:
English: Fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction.
Danish: Fibrin-vævsklæbere kan i sjældne tilfælde (op til 1 ud af 1.000 mennesker) forårsage en allergisk reaktion.
English: ● EVARREST must not be applied intravascularly.
Danish: ● EVARREST må ikke appliceres intravaskulært.
English: Talk to your surgeon before you are treated with EVARREST.
Danish: Tal med kirurgen, inden du behandles med EVARREST.
English: Therefore, the product should be administered to pregnant and lactating women only if clearly needed.
Danish: Produktet bør derfor kun administreres til gravide og ammende kvinder, hvis det er klinisk indiceret.
English: Using 125I-thrombin it was shown that a slow absorption of biologically inactive peptides resulting from the breakdown of thrombin occurred, reaching a Cmax in the plasma after 6-8 hours.
Danish: Ved anvendelse af 125I-thrombin blev det påvist, at der sker langsom absorption af biologisk inaktive peptider som følge af nedbrydning af trombin, og at Cmax i plasma nås efter 6-8 timer.
English: EVARREST should not be used in place of sutures or other forms of mechanical ligation for the treatment of major arterial bleeding.
Danish: EVARREST bør ikke anvendes i stedet for suturer eller andre former for mekanisk ligatur til behandling af større arteriel blødning.
English: Such reactions may especially be seen if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Danish: Sådanne reaktioner kan især ses, hvis præparatet appliceres gentagne gange eller administreres til patienter med kendt overfølsomhed over for produktets bestanddele.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Danish: De trufne foranstaltninger kan have begrænset værdi mod ikkekappeklædte vira såsom parvovirus B19.
English: For any information about this medicine, please contact the Manufacturer:
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til fremstilleren:
English: Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing alcohol, iodine, or heavy metals (e.g., antiseptic solutions).
Danish: I lighed med sammenlignelige produkter eller trombinopløsninger kan produktet denaturere efter eksponering for opløsninger, der indeholder alkohol, jod eller tungmetaller (fx antiseptiske opløsninger).
English: All adverse reactions reported during the clinical trials occurred at a frequency of less than 1% (uncommon).
Danish: Alle bivirkninger, der blev rapporteret under de kliniske forsøg, forekom med en hyppighed på under 1 % (ikke almindelige).
English: The safety data for EVARREST reflect the types of post-operative complication generally related to the surgical settings in which the trials were conducted and the underlying disease of the patients.
Danish: Sikkerhedsdataene for EVARREST afspejler de postoperative komplikationstyper, der almindeligvis er relateret til de kirurgiske omgivelser, hvori forsøgene blev udført, samt patienternes underliggende sygdomme.
English: The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
Danish: Hvor meget EVARREST, der skal anvendes, afhænger af flere variabler, herunder (men ikke begrænset til) typen af kirurgisk indgreb, arealets størrelse, den tilsigtede appliceringsmåde samt antal appliceringer.
English: This also applies to any unknown or emerging viruses, or other types of infections.
Danish: Dette gælder også eventuelle ukendte eller nyopståede vira eller andre infektionstyper.
English: The application site should be monitored intraoperatively to verify that haemostasis is maintained.
Danish: Appliceringsstedet bør monitoreres intraoperativt for at bekræfte, at hæmostase opretholdes.
English: The Matrix provides physical support and a large surface area for the biological components, imparts inherent mechanical integrity to the product and supports clot formation.
Danish: Matrixen yder fysisk støtte og et stort overfladeareal til de biologiske komponenter, giver iboende mekanisk integritet til produktet og fremmer koageldannelsen.
English: It is left in place after the operation and is absorbed by the body.
Danish: Det bliver siddende efter operationen og optages i kroppen.
English: This could result in problems with healing.
Danish: Det kan medføre problemer med helingen.
English: The safety of fibrin sealants/haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Danish: Fibrinvævsklæberes/hæmostatikas sikkerhed til anvendelse ved human graviditet eller under amning er endnu ikke klarlagt i kontrollerede kliniske forsøg.
English: In contact with physiological fluids, e.g., blood, lymph, or physiological saline, the components of the coating are activated, and the reaction of fibrinogen and thrombin initiates the last phase of physiological blood coagulation.
Danish: I kontakt med fysiologiske væsker, fx blod, lymfe eller fysiologisk saltvand, aktiveres belægningens komponenter, og reaktionen mellem fibrinogen og trombin initierer den sidste fase i den fysiologiske blodkoagulation.
English: When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Danish: Når lægemidler fremstilles af humant blod eller plasma, træffes der visse foranstaltninger for at forhindre, at infektioner overføres til patienter.
English: EVARREST should only be used in a single layer.
Danish: EVARREST bør kun anvendes i et enkelt lag.
English: Table 1 Summary of Adverse Reactions to EVARREST MedDRA System Organ Class Preferred Term
Danish: Opsummering af bivirkninger ved EVARREST MedDRA-systemorganklasse Foretrukken betegnelse
English: Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation, and peri- and post-natal development.
Danish: Eksperimentelle dyreforsøg er utilstrækkelige til at vurdere sikkerheden med hensyn til reproduktion, embryonal og føtal udvikling, gestationens forløb og den peri- og postnatale udvikling.
English: Re-Treatment
Danish: Genbehandling
English: The fibrin is then cross-linked by endogenous Factor XIII, creating a firm, mechanically stable fibrin network with good adhesive properties.
Danish: Fibrinet krydsbindes derefter af endogen faktor XIII, så der dannes et fast, mekanisk stabilt fibrinnetværk med gode adhæsive egenskaber.
English: Keep EVARREST dry after opening.
Danish: Hold EVARREST tør efter åbning.
English: EVARREST does not stick to gloves, forceps, or surgical instruments.
Danish: EVARREST klæber ikke fast til handsker, tænger eller kirurgiske instrumenter.
English: Studies have been conducted in rabbits to evaluate the absorption and elimination of thrombin when applied to the cut surface of the liver resulting from partial hepatectomy.
Danish: Der er udført forsøg med kaniner for at evaluere trombins absorption og elimination, når det appliceres på snittede leverflader efter partiel hepatektomi.
English: The amount of EVARREST to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
Danish: Hvor meget EVARREST, der skal anvendes, og hvor hyppigt det anvendes, bør altid dikteres af patientens underliggende kliniske behov.
English: Bleeding areas larger than those which can be covered by a single unit of EVARREST have not been investigated in clinical studies.
Danish: Blødende områder, der er for store til at kunne dækkes af et enkelt stykke EVARREST, er endnu ikke blevet undersøgt i kliniske forsøg.
English: Human fibrinogen (8.1 mg/cm2) Human thrombin (40 IU/ cm2)
Danish: - Humant fibrinogen (8,1 mg/cm2) - Humant thrombin (40 IE/ cm2)
English: As with any product which is implanted, the body may develop a reaction to the foreign material.
Danish: Ligesom med andre implanterede produkter kan kroppen udvikle en reaktion mod det fremmede materiale.
English: Discard damaged packages as re-sterilisation is not possible.
Danish: Beskadigede pakninger skal kasseres, da resterilisering ikke er mulig.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: Standardforanstaltninger til forebyggelse af infektioner som følge af anvendelse af lægemidler, der er fremstillet af humant blod eller plasma, omfatter donorudvælgelse, screening af individuelle donationer og plasmapuljer for specifikke infektionsmarkører og inddragelse af effektive fremstillingstrin til inaktivering/fjernelse af vira.
English: Applications for which adequate data are not available Adequate data are not available to support the use of this product in neurosurgery or application through a flexible endoscope for treatment of bleeding, in vascular surgery, or in gastrointestinal anastomoses.
Danish: Anvendelser for hvilke der ikke foreligger tilstrækkelige data Der foreligger ikke tilstrækkelige data til understøttelse af dette produkts anvendelse til neurokirurgi eller applicering gennem et fleksibelt endoskop til behandling af blødning, til karkirurgi eller til gastrointestinale anastomoser.
English: If you experience any of these symptoms after surgery you should consult your doctor or surgeon.
Danish: Hvis du får nogen af disse symptomer efter operationen, bør du spørge din læge eller kirurg til råds.
English: The clot formation of EVARREST is integrated with the Matrix; it forms a mechanical barrier to bleeding and reinforces the wound site.
Danish: EVARRESTs koageldannelse er integreret med matrixen; den danner en mekanisk barriere mod blødning og forstærker sårstedet.
English: EVARREST will remain in place and adhere to the tissue, and is absorbable.
Danish: EVARREST vil blive siddende og klæbe fast til vævet og er absorberbar.
English: EVARREST is intended for epilesional use only.
Danish: EVARREST er kun beregnet til epilæsional anvendelse.
English: It is applied by pressing firmly onto bleeding tissue for approximately 3 minutes.
Danish: Det påføres ved at trykke det fast mod blødende væv i ca. 3 minutter.
English: It is applied directly onto tissue where it sticks firmly and stops bleeding.
Danish: Det lægges direkte oven på vævet, hvor det klistrer sig fast og standser blødningen.
English: Fibrin sealants/haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Danish: Fibrinvævsklæbere/hæmostatika metaboliseres på samme måde som endogent fibrin ved fibrinolyse og fagocytose.
English: The product is activated upon contact with fluid, and adheres and conforms to tissue.
Danish: Produktet aktiveres ved kontakt med væske og klæber til og tilpasser sig vævet.
English: There is not enough information available to know whether any particular risks are associated with the use of EVARREST during pregnancy or whilst breast-feeding, or whether it could affect fertility.
Danish: De tilgængelige oplysninger er ikke tilstrækkelige til at fastslå, om brug af EVARREST under graviditet eller amning indebærer nogen særlig risiko, eller om det kan påvirke fertiliteten.
English: The use of EVARREST is restricted to experienced surgeons.
Danish: EVARREST må udelukkende anvendes af erfarne kirurger.
English: One (1/75) adverse reaction of deep vein thrombosis was reported in the EVARREST group.
Danish: Der blev rapporteret én (1/75) bivirkning i form af dyb venetrombose i EVARREST-gruppen.
English: A 90-day study in rats to evaluate subchronic systemic toxicity and immunogenicity of EVARREST after subcutaneous implantation found no signs of toxic effects and no evidence of increased immunogenicity relative to fibrin sealant products.
Danish: Et 90-dages forsøg med rotter til evaluering af EVARRESTs subkroniske systemiske toksicitet og immunogenicitet efter subkutan implantation fandt ingen tegn på toksiske virkninger og ingen evidens for øget immunogenicitet i forhold til fibrinvævsklæberprodukter.
English: Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15 1831 Diegem
Danish: Omrix Biopharmaceuticals NV Leonardo Da Vincilaan 15 1831 Diegem
English: UNIQUE IDENTIFIER-2DBARCODE 2D barcode carrying the unique identifier included.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator.
English: EVARREST contains Human Fibrinogen and Human Thrombin as a dried coating on the surface of an absorbable composite Matrix.
Danish: EVARREST indeholder humant fibrinogen og humant trombin som en tørret belægning på overfladen af en absorberbar kompositmatrix.
English: Life-threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Danish: Der kan opstå livstruende tromboemboliske komplikationer, hvis præparatet utilsigtet appliceres intravaskulært.
English: If haemostasis is not reached with one application of EVARREST, re-treatment may be administered.
Danish: Hvis der ikke opnås hæmostase med én applicering af EVARREST, kan en genbehandling administreres.
English: The size of EVARREST should be limited to what is necessary to stop bleeding.
Danish: Størrelsen af EVARREST bør begrænses til det, der er nødvendigt for at standse blødningen.
English: The foil sachet protects EVARREST from moisture and from microbiological contamination.
Danish: Folieposen beskytter EVARREST mod fugt og mod forurening med mikroorganismer.
English: • Risk Management Plan (RMP) The Marketing Authorization Holder (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 updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede lægemiddelovervågningsaktiviteter og foranstaltninger, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: 5a) Hold dry or moist surgical gauze or laparotomy pads over EVARREST to achieve full contact with the bleeding surface.
Danish: 5a) Hold tør eller fugtig kirurgisk gaze eller laparotomiske kompresser over EVARREST for at opnå fuld kontakt med den blødende overflade.
English: The haemostatic efficacy of EVARREST was demonstrated in a number of animal models assessing time to haemostasis and post-treatment blood loss, among other endpoints.
Danish: EVARRESTs hæmostatiske effekt er blevet påvist i en række dyremodeller, som blandt andre endepunkter vurderede tid til hæmostase og blodtab efter behandling.
English: In clinical trials of EVARREST no difference has been observed between EVARREST and control groups with regard to the incidence of thrombotic events, currently suggesting no increased risk with EVARREST use.
Danish: I kliniske forsøg med EVARREST er der ikke observeret nogen forskel på EVARREST og kontrolgrupperne for så vidt angår forekomsten af trombotiske hændelser, hvilket aktuelt tyder på, at der ikke er nogen forhøjet risiko ved anvendelse af EVARREST.
English: The non-active side has an embossed wave pattern.
Danish: Den ikke-aktive side er præget med et bølgemønster.
English: If you get any side effects, talk to your doctor or surgeon.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge eller kirurg.
English: The active side of the sealant matrix is powdery, and the non-active side has an embossed wave pattern.
Danish: Vævsklæber-matrixens aktive side er pudderagtig, og den ikke-aktive side er præget med et bølgemønster.
English: EVARREST is applied during surgical operations in adult subjects, to stop bleeding and oozing during the operation.
Danish: EVARREST anvendes under kirurgiske indgreb hos voksne patienter til at standse blødning og siveblødning under operationen.
English: - for improvement of haemostasis.
Danish: - til forbedring af hæmostase.
English: It is strongly recommended that every time EVARREST is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Danish: Det anbefales stærkt, at produktets navn og batchnummer registreres, hver gang EVARREST administreres til en patient, for at bevare en kobling mellem patient og produktbatch.
English: The overall incidence of deep vein thrombosis observed during clinical trials was consistent with published data and does not suggest an increased risk for thrombotic events in EVARREST-treated subjects, although from the available data, this risk cannot be completely ruled out.
Danish: Den samlede forekomst af dyb venetrombose, der er observeret under kliniske forsøg, svarede til de offentliggjorte data og tyder ikke på nogen forhøjet risiko for trombotiske hændelser hos de EVARREST-behandlede forsøgspersoner, selvom man på baggrund af de tilgængelige data ikke kan udelukke denne risiko helt.
English: The bleeding source should be clearly identified, and it must be ensured that EVARREST is applied directly onto the bleeding source by covering it completely.
Danish: Blødningskilden bør identificeres tydeligt, og det skal sikres, at EVARREST appliceres direkte på blødningskilden ved at dække den fuldstændigt.
English: Do not apply intravascularly
Danish: Må ikke appliceres intravaskulært
English: Telephone: +32 2 746 30 00 Telefax: + 32 2 746 30 01
Danish: Telefon: +32 2 746 30 00 Telefax: + 32 2 746 30 01
English: Pharmacotherapeutic group: antihaemorrhagics, local haemostatics, ATC code: B02BC30
Danish: Farmakoterapeutisk klassifikation: hæmostatika, hæmostatika til lokal brug, ATC-kode: B02BC30
English: The European Medicines Agency has deferred the obligation to submit the results of studies with EVARREST in one or more subsets of the paediatric population for the treatment of haemorrhage resulting from a surgical procedure (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med EVARREST i en eller flere undergrupper af den pædiatriske population til behandling af blødning som følge af et kirurgisk indgreb (se pkt.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: If no other primary haemostatic measures (i.e., standard surgical techniques) appear to be required, repeat the application procedure above with a new EVARREST sealant matrix.
Danish: Hvis der ikke synes at være behov for andre primære hæmostatiske foranstaltninger (dvs. kirurgiske standardteknikker), gentages ovenstående appliceringsprocedure med en ny EVARREST vævsklæber-matrix.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside:http://www.ema.europa.eu.
English: In clinical trials, the most frequently reported adverse reactions were haemorrhage and increased fibrinogen, and the most serious adverse reactions were aspiration, pulmonary embolism, and haemorrhage.
Danish: I kliniske forsøg var de mest hyppigt indberettede bivirkninger blødning og øget fibrinogen, og de alvorligste bivirkninger var aspiration, lungeemboli og blødning.
English: The safety and efficacy of EVARREST in children from birth to 18 years has not yet been established.
Danish: EVARRESTs sikkerhed og virkning hos børn i alderen 0-18 år er endnu ikke klarlagt.
English: - If you have any further questions, ask your doctor.
Danish: - Spørg lægen, hvis der er mere du vil vide.
English: EVARREST is activated upon contact with blood or other fluid and will stick firmly to the tissue.
Danish: EVARREST aktiveres ved kontakt med blod eller anden væske og vil klæbe fast til vævet.
English: EVARREST contains the components of fibrin sealant.
Danish: EVARREST indeholder de komponenter, der findes i fibrin-vævsklæber.
English: EVARREST must not be used to repair injuries to the wall of large arteries or veins where the product is exposed to constant blood flow and pressure.
Danish: EVARREST må ikke anvendes til reparation af skader på store arteriers eller veners vægge, hvor produktet udsættes for konstant blodstrøm og -tryk.
English: ● Keep EVARREST dry after opening.
Danish: ● Hold EVARREST tør efter åbning.
English: The measures taken in the manufacture of fibrinogen and thrombin are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped virus, hepatitis A. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Danish: De foranstaltninger, der træffes under fremstillingen af fibrinogen og thrombin, anses for at være effektive mod kappeklædte vira såsom humant immundefektvirus (HIV), hepatitis B-virus og hepatitis C-virus og for det ikke-kappeklædte virus, hepatitis A. De trufne foranstaltninger kan have begrænset værdi mod ikke-kappeklædte vira såsom parvovirus B19.
English: Allergic-type hypersensitivity reactions are possible.
Danish: Overfølsomhedsreaktioner af allergitypen kan forekomme.
English: Non-clinical data on the Matrix component reveal no special hazard for humans based on studies of cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity, genotoxicity, implantation, and hemocompatibility.
Danish: Prækliniske data for matrixkomponenterne viser ingen speciel risiko for mennesker vurderet ud fra studier af cytotoksicitet, sensibilisering, intrakutane reaktioner, akut systemisk toksicitet, materialemedieret pyrogenicitet, subkronisk toksicitet, genotoksicitet, implantation og hæmokompatibilitet.
English: EVARREST contains sodium
Danish: EVARREST indeholder natrium
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped virus hepatitis A virus (HAV).
Danish: De trufne foranstaltninger anses for at være effektive mod kappeklædte vira såsom humant immundefektvirus (HIV), hepatitis B-virus (HBV) og hepatitis C-virus (HCV) og for det ikkekappeklædte virus, hepatitis A (HAV).