FrancophonIA/ELRC3.0 huggingface dataset:
English: For spray application, see sections 4.4 and 6.6 for specific recommendations on the required distance from tissue per surgical procedure.
Danish: 4.4 og 4.6 for specifikke anbefalinger om den påkrævede afstand fra vævet pr. kirurgiske indgreb.
English: Hypersensitivity*
Danish: Overfølsomhed*
English: Consequently, intravascular pharmacokinetic studies were not performed in man.
Danish: Som følge heraf er der ikke blevet udført intravaskulære farmakokinetiske studier hos mennesker.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper)
English: The amount of VeraSeal that will be applied depends on a number of factors, including the type of surgery, the size of the area to be treated during your operation and the way VeraSeal is applied.
Danish: Den mængde VeraSeal, der påføres, afhænger af flere forskellige faktorer, herunder typen af kirurgi, størrelsen af det område, der skal behandles under operationen, og den måde, VeraSeal påføres på.
English: Side effects which were reported during clinical trials with VeraSeal included:
Danish: Bivirkninger, som blev rapporteret i løbet af kliniske studier med VeraSeal, omfattede:
English: • Sterile Water Bath (Quick Thawing)
Danish: • Sterilt vandbad (hurtig optøning)
English: Drug specific antibody present*
Danish: Lægemiddelspecifikt antistof til stede* Ikke kendt
English: Manufacturers also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Fremstillerne indbygger også trin under behandlingen af blod eller plasma, der kan inaktivere eller fjerne vira.
English: VeraSeal comes ready to use in sterilized packages and must be handled using sterile technique in aseptic conditions.
Danish: VeraSeal fås i steriliserede pakninger, der er klar til brug, og de skal håndteres med steril teknik under aseptiske forhold.
English: Ecchymosis, erythema
Danish: Ekkymose, erytem
English: If these symptoms occur during surgery, the use of the medicine should be stopped immediately.
Danish: Hvis disse symptomer opstår under operationen, skal brugen af lægemidlet straks stoppes.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) AF DET (DE) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: The safety of fibrin sealant/haemostatic products for use in human pregnancy or breast-feeding has not been established in controlled clinical trials.
Danish: Sikkerheden af fibrin-vævsklæber/hæmostatiske præparater til anvendelse under graviditet eller amning hos mennesker er ikke klarlagt i kontrollerede, kliniske studier.
English: The cold storage chain (- 18 ºC or colder) must not be interrupted until use.
Danish: Den kolde opbevaringskæde (ved -18 ºC eller koldere) må ikke brydes før brug.
English: To prevent uncontrolled clotting, allow the drops to separate from each other and from the end of the drip tip.
Danish: For at undgå ukontrolleret koagulation skal dråberne være adskilte fra hinanden og fra enden af drypspidsen.
English: It is strongly recommended that every time you are treated with VeraSeal, the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Danish: Det anbefales på det kraftigste, at navn og batchnummer for lægemidlet registreres, hver gang du behandles med VeraSeal, for at registrere de anvendte batchnumre.
English: - Nausea - Pain caused by the surgery - Pruritus (itching)
Danish: - Kvalme - Smerter fra operationen - Pruritus (kløe)
English: These include carefully selecting blood and plasma donors to make sure those at risk of carrying infections are excluded, and testing each donation and pooled plasma for signs of virus/infections.
Danish: Dette omfatter nøje udvælgelse af blod- og plasmadonorer, så det sikres, at personer med risiko for at være smittebærere ikke anvendes, og kontrol af hver donation og puljet plasma for tegn på virus/infektioner.
English: If this product is accidentally placed inside a blood vessel, it can lead to blood clots, including disseminated intravascular coagulation (DIC) (when blood clots form throughout the blood vessels in the body).
Danish: Hvis dette præparat utilsigtet placeres inde i et blodkar, kan det føre til blodpropper, herunder dissemineret intravaskulær koagulation (DIC) (hvor der dannes blodpropper spredt rundt iblodkarrene i kroppen).
English: For medicines such as VeraSeal that are made from human blood or plasma, certain measures are taken to prevent infections being passed on to patients.
Danish: For lægemidler som VeraSeal, der er fremstillet ud fra humant blod eller plasma, tages der visse forholdsregler, så det undgås, at infektioner overføres til patienterne.
English: Human thrombin 500 IU/ml Produced from the plasma of human donors.
Danish: Humant trombin 500 IE/ml Fremstillet af donorplasma fra mennesker.
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: Standardforholdsregler for at forhindre infektioner, der skyldes brugen af lægemidler fremstillet fra humant blod eller plasma, inkluderer udvælgelse af donorer, screening af individuelle donationer og plasmaportioner for specifikke infektionsmarkører og inklusion af effektive fremstillingstrin til inaktivering/fjernelse af vira.
English: If expression is stopped for any reason, change the Airless Spray Tip.
Danish: Hvis udpresningen af en eller anden grund stopper, udskiftes den luftfrie sprøjtespids.
English: • Disposal
Danish: • Bortskaffelse
English: VeraSeal spray application should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy.
Danish: VeraSeal sprøjteapplikation må kun anvendes, hvis det er muligt nøjagtigt at bedømme sprøjteafstanden, især under laparoskopi.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with VeraSeal in one or more subsets of the paediatric population for the treatment of haemorrhage resulting from a surgical procedure as per paediatric investigational plan (PIP) decision, for the granted indication (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med VeraSeal i en eller flere undergrupper af den pædiatriske population ved behandling af blødning fra et kirurgisk indgreb for den godkendte indikation i henhold til afgørelsen i den pædiatriske undersøgelsesplan (PIP) (se pkt.
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 kirurgen.
English: VeraSeal must not be used to treat severe or rapid bleeding from an artery.
Danish: VeraSeal må ikke anvendes til at behandle en svær eller hurtigtflydende blødning fra en arterie.
English: Thaw VeraSeal pre-filled syringes inside the sterile field in a sterile thermostatic water bath at a temperature not higher than 37 ºC using the following steps:
Danish: Optø VeraSeal fyldte sprøjter i det sterile område i et sterilt, termostatisk vandbad ved en temperatur, der ikke overstiger 37 ºC, ved at følge disse trin:
English: The product should only be administered according to the instructions and with the devices recommended for this product (see section 6.6.
Danish: Præparatet må kun administreres i henhold til anvisningerne og med det anbefalede udstyr til dette præparat (se pkt.
English: VeraSeal is available in the following pack sizes:
Danish: VeraSeal fås i de følgende pakningsstørrelser:
English: The most frequent surgery types were simple or radical hysterectomies, abdominoplasties, and radical cystectomies.
Danish: De hyppigste former for kirurgi var simpel eller radikal hysterektomi, abdominalplastik og radikal cystektomi.
English: Position the Airless Spray Tip at least 2 cm away from the target tissue.
Danish: Placer den luftfrie sprøjtespids mindst 2 cm væk fra målvævet.
English: Prior to applying VeraSeal, the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Danish: Før VeraSeal appliceres, skal overfladen af sårområdet tørres med standardteknikker (f.eks. periodisk applikation af kompresser, gazetamponer, brug af udstyr med sug).
English: NOTE: Do not depress plunger during attachment or prior to intended use because the two biologic components will pre-mix in the Airless Spray Tip, forming a fibrin clot that prevents dispensing.
Danish: BEMÆRK: Stemplet må ikke trykkes ned under påsætningen eller inden den tilsigtede anvendelse, da de to biologiske komponenter vil blandes i den luftfrie sprøjtespids og danne en fibrinprop, der forhindrer dispensering.
English: The surgeon will apply VeraSeal to the surface of blood vessels or to the tissue surface of internal organs using an application device during the course of the operation.
Danish: Kirurgen vil påføre VeraSeal på overfladen af blodkar eller på vævsoverfladerne af indre organer med påføringsudstyr i løbet af operationen.
English: Deep vein thrombosis, hypertension, hypotension
Danish: Dyb venetrombose, hypertension, hypotension
English: During dripping, keep the end of the drip tip as close to the tissue surface as possible without touching the tissue during application.
Danish: Under drypningen holdes enden af drypspidsen så tæt på vævsoverfladen som muligt, men uden at berøre vævet under applikationen.
English: Glutamic acid monosodium Water for injections
Danish: Glutaminsyre mononatrium Vand til injektionsvæsker
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Danish: Antistoffer mod komponenter af fibrin-vævsklæber/hæmostatiske præparater kan fremkomme i sjældne tilfælde.
English: Headache, somnolence
Danish: Hovedpine, somnolens
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer):
English: The product may be affected after contacting solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).
Danish: Præparatet kan påvirkes efter kontakt med opløsninger, der indeholder alkohol, jod eller tungmetaller (f.eks. antiseptiske opløsninger).
English: VeraSeal spray application should only be used if it is possible to accurately judge the spray distance.
Danish: VeraSeal sprøjteapplikation må kun anvendes, hvis det er muligt nøjagtigt at bedømme sprøjteafstanden.
English: Most serious side effects
Danish: Mest alvorlige bivirkninger
English: Currently available data are described in section 5.1, but no recommendation on a posology can be made.
Danish: 5.1, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.
Danish: Konvertering af fibrinogen til fibrin sker, ved at fibrinogen spaltes til fibrin-monomerer og fibrin-peptider.
English: NOTE: Do not reconnect a used drip tip after it has been removed from the adapter; otherwise a clot may form inside the drip tip and the applicator may become unusable.
Danish: BEMÆRK: Sæt ikke en brugt drypspids på igen, efter den er blevet fjernet fra adapteren, da der i så fald kan dannes en prop inde i drypspidsen, og applikatoren kan blive ubrugelig.
English: Adequate data are not available to support the use of this product in tissue gluing, neurosurgery, application through a flexible endoscope for treatment of bleeding or in gastrointestinal anastomoses.
Danish: Der er ikke tilstrækkelige data til rådighed til at støtte anvendelsen af dette præparat til vævsadhæsion, neurokirurgi, applikation via et fleksibelt endoskop til behandling af blødning eller ved mave-tarmanastomoser.
English: 1 Dual Applicator with 2 additional Airless Spray Tips.
Danish: 1 dobbeltapplikator med 2 ekstra luftfrie sprøjtespidser.
English: Place the blister containing the syringe holder with pre-filled syringes on a surface at room temperature (20 ºC - 25 ºC) for approximately 70 minutes for the 2 ml and the 4 ml package sizes for approximately 90 minutes for the 6 ml and the 10 ml package sizes
Danish: Placer blisteren, der indeholder sprøjteholderen med fyldte sprøjter, på en overflade ved stuetemperatur (20 ºC - 25 ºC) i ca. 70 minutter for pakningsstørrelser med 2 ml og 4 ml i ca. 90 minutter for pakningsstørrelser med 6 ml og 10 ml
English: Atrial fibrillation, ventricular tachycardia
Danish: Atrieflimmer, ventrikulær takykardi
English: Spray distance from tissue should be within the range recommended by the marketing authorisation holder of VeraSeal (see section 6.6).
Danish: Sprøjteafstanden fra vævet skal være inden for det anbefalede interval fra indehaveren af markedsføringstilladelsen for VeraSeal (se pkt.
English: The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of this medicinal product.
Danish: Anvendelsen af VeraSeal er begrænset til erfarne kirurger med træning i anvendelsen af dette lægemiddel.
English: Discard damaged packages as re-sterilisation is not possible.
Danish: Bortskaf beskadigede pakninger, da gensterilisering ikke er mulig.
English: The Airless Spray Tips are radiopaque.
Danish: De luftfrie sprøjtespidser er røntgentætte.
English: As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Danish: Når sårhelingen skrider fremad, inducerer plasmin en øget fibrinolytisk aktivitet, og degraderingen af fibrin til fibrin-nedbrydningsprodukter påbegyndes.
English: VeraSeal is used as a sealant during surgical operations in adults.
Danish: VeraSeal anvendes som en vævsklæber under kirurgi hos voksne.
English: - Very common (≥1/10) - common (≥1/100 to <1/10) - uncommon (≥1/1,000 to <1/100) - rare (≥1/10,000 to <1/1,000)
Danish: Hyppighederne er blevet evalueret i henhold til den følgende konvention: - meget almindelig (≤ 1/10) - almindelig (≤ 1/100 til < 1/10) - ikke almindelig (≤ 1/1.000 til <1/100) - sjælden (≤ 1/10.000 til < 1/1.000) - meget sjælden (< 1/10.000) - ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: If you experience any of these symptoms after surgery, you should immediately consult your doctor or surgeon.
Danish: Hvis du oplever et eller flere af disse symptomer efter operationen, skal du straks kontakte lægen eller kirurgen.
English: The active substances are: - Component 1: Human fibrinogen - Component 2: Human thrombin
Danish: Aktive stoffer: - Komponent 1: Humant fibrinogen - Komponent 2: Humant trombin
English: Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Danish: Livstruende tromboemboliske komplikationer kan opstå, hvis præparatet utilsigtet appliceres intravaskulært.
English: Allergic reactions may especially be seen if the preparation is applied repeatedly, or administered to patients known to be allergic to constituents of the product.
Danish: Allergiske reaktioner kan især ses, hvis præparatet påføres gentagne gange, eller ved administration til patienter, der vides at være allergiske over for præparatets bestanddele.
English: • Connection instructions
Danish: • Tilslutningsanvisninger
English: After thawing, remove the blister from the surface at room temperature or from the refrigerator at 2 °C - 8 °C.
Danish: Efter optøning fjernes blisteren fra overfladen ved stuetemperatur eller fra køleskabet ved 2 °C - 8 °C.
English: Frequency of Adverse Reactions (ADRs) in clinical studies with VeraSeal:
Danish: Hyppighed af bivirkninger i kliniske studier med VeraSeal:
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 fremstillingen appliceres gentagne gange, eller ved administration til patienter, der vides at være overfølsomme over for præparatets bestanddele.
English: Supportive treatment in adults where standard surgical techniques are insufficient:
Danish: Støttebehandling hos voksne, hvor standard kirurgiske teknikker er utilstrækkelige: - til forbedring af hæmostase.
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: Som for tilsvarende præparater eller trombinopløsninger kan præparatet denatureres efter eksponering for opløsninger, der indeholder alkohol, jod eller tungmetaller (f.eks. antiseptiske opløsninger).
English: For storage conditions after thawing the medicinal product and after first opening, see section 6.3.
Danish: Opbevaringsforhold efter optøning af lægemidlet og efter første anbrud, se pkt.
English: Fibrin sealant/haemostatic products are metabolised in the same way as endogenous fibrin by fibrinolysis and phagocytosis.
Danish: Fibrin-vævsklæber/hæmostatiske præparater metaboliseres på samme måde som endogent fibrin ved fibrinolyse og fagocytose.
English: Parvovirus B19 test positive, activated partial thromboplastin time prolonged, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increase, blood glucose increase, international normalised ratio increased, prothrombin time prolonged, transaminases increased, urine output decreased
Danish: Positiv parvovirus B19-test, forlænget aktiveret partiel tromboplastintid, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjet bilirubin i blodet, forhøjet glucose i blodet, forhøjet international normaliseret ratio, forlænget protrombintid, forhøjede transaminaser, nedsat urinoutput
English: In isolated cases, these reactions may progress to a severe allergic reaction.
Danish: I enkelte tilfælde kan disse reaktioner forværres til en svær allergisk reaktion.
English: The mean age of the study population and its standard deviation was 57.9 (14.5) years.
Danish: Gennemsnitsalderen for studiepopulationen og standardafvigelsen var 57,9 (14,5) år.
English: In isolated cases, these reactions have progressed to severe anaphylaxis.
Danish: I enkelte tilfælde er disse reaktioner forværret til svær anafylaksi.
English: Can Guasc, 2 - Parets del Vallès E-08150 Barcelona - Spain
Danish: Can Guasc, 2 - Parets del Vallès E-08150 Barcelona - Spanien
English: Then, connect a new Airless Spray Tip provided in the package and ensure it is firmly connected before use.
Danish: Tilslut dernæst en ny luftfri sprøjtespids fra pakningen, og sørg for, at den sidder godt fast inden brug.
English: Place the syringe holder with pre-filled syringes directly into the sterile water bath ensuring that it is completely immersed in the water.
Danish: Placer sprøjteholderen med fyldte sprøjter direkte i det sterile vandbad, og sørg for, at den er helt nedsænket i vandet.
English: VeraSeal must not be used for the treatment of severe or brisk arterial bleeding.
Danish: VeraSeal må ikke bruges til at behandle alvorlig eller kraftig arterieblødning.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing of seriousness.
Danish: Inden for hver enkelt hyppighedsgruppering er bivirkningerne opstillet efter, hvor alvorlige de er.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT Risk management plan (RMP) The marketing authorisation 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 aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Calcium ions are required for both, the conversion of fibrinogen and the crosslinkage of fibrin.
Danish: Calciumioner er nødvendige for både konverteringen af fibrinogen og krydsbindingen af fibrin.
English: The mean age of the study population and its standard deviation was 47.2 (18.4) years.
Danish: Gennemsnitsalderen for studiepopulationen og standardafvigelsen var 47,2 (18,4) år.
English: The mean age of the study population and its standard deviation was 63.2 (9.5) years.
Danish: Gennemsnitsalderen for studiepopulationen og standardafvigelsen var 63,2 (9,5) år.
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: Solutions that are cloudy or have deposits should not be used.
Danish: Opløsninger, der er uklare eller indeholder partikler, må ikke anvendes.
English: Can Guasc, 2 - Parets del Vallès E-08150 Barcelona Spain
Danish: Can Guasc, 2 - Parets del Vallès E-08150 Barcelona Spanien
English: Inadvertent intravascular injection could lead to thromboembolic event and disseminated intravascular coagulation (DIC), and there is also a risk of anaphylactic reaction (see section 4.4).
Danish: Utilsigtet intravaskulær injektion kan føre til tromboembolisk hændelse og dissemineret intravaskulær koagulation (DIC), og der er også en risiko for en anafylaktisk reaktion (se pkt.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of VeraSeal.
Danish: Anvendelsen af VeraSeal er begrænset til erfarne kirurger med træning i anvendelsen af VeraSeal.
English: VeraSeal contains the component of fibrin sealant.
Danish: VeraSeal indeholder komponenten af fibrin-vævsklæber.
English: This leaflet was last revised in.
Danish: Denne indlægsseddel blev senest ændret.
English: Pharmacotherapeutic group: Antihaemorrhagics, local hemostatics, ATC code: B02BC
Danish: Farmakoterapeutisk klassifikation: Hæmostatika, hæmostatika til lokal brug, ATC-kode: B02BC.
English: VeraSeal should be applied as a thin layer.
Danish: VeraSeal skal appliceres som et tyndt lag.
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Danish: Parvovirus B19-infektioner kan være alvorlige for gravide kvinder (føtal infektion) og for personer med immundefekt eller med øget erytropoiese (f.eks. hæmolytisk anæmi).
English: Apply individual drops to the surface area to be treated.
Danish: Applicer enkelte dråber på måloverfladen, der skal behandles.
English: • Room temperature thawing (preferred method)
Danish: • Optøning ved stuetemperatur (foretrukken metode)
English: Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Danish: Hvis blodkoagelen er for tyk, kan det påvirke præparatets virkning og sårhelingsprocessen negativt.