FrancophonIA/ELRC3.0 huggingface dataset:
English: TachoSil is indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, for suture support in vascular surgery where standard techniques are insufficient, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).
Danish: TachoSil anvendes til voksne under kirurgiske indgreb som understøttende behandling til forbedring af hæmostase, til at fremme vævsforsegling, til at støtte sutur ved karkirurgiske operationer, hvor standardmetoder er utilstrækkelige, og til støttende forsegling af dura mater for at forebygge postoperativ lækage af cerebrospinalvæske efter neurokirurgi (se pkt 5.1).
English: A clinical study has shown that some patients produced antibodies against the components of TachoSil, however, no side effects were reported resulting from the development of these antibodies.
Danish: Et klinisk studie har vist, at nogle patienter dannede antistoffer mod komponenterne i TachoSil, men der blev ikke indberettet nogen bivirkninger, som var opstået på baggrund af dannelse af disse antistoffer.
English: Complete degradation of TachoSil was seen in some animals 12 months after its administration to a liver wound, whereas small remnants were still observed in others.
Danish: En fuldstændig nedbrydning af TachoSil blev set hos nogle dyr 12 måneder efter administration på leversår, mens små tilbageværende rester blev observeret hos andre.
English: The pre-rolled TachoSil should not be pre-moistened before passing through the trocar or port.
Danish: Den prærullede TachoSil bør ikke fugtes, før den passerer gennem trokaren eller porten.
English: The degradation was associated with infiltration of granulocytes and formation of resorptive granulation tissue encapsulating the degraded remnants of TachoSil.
Danish: Nedbrydningen var forbundet med infiltrering af granulocytter og dannelse af resorptivt granulationsvæv, som indkapslede de nedbrudte rester af TachoSil.
English: Tissue sealing in lung surgery was investigated in two controlled trials in patients undergoing lung surgery.
Danish: Vævsforsegling ved lungekirurgi blev undersøgt i to kontrollerede undersøgelser med patienter, der fik foretaget lungekirurgi.
English: Prior to application the wound area should be cleansed, e.g. from blood, disinfectants and other fluids.
Danish: Forud for applikation bør såret renses for blod, desinfektionsmidler og andre væsker.
English: Fibrinogen is converted into fibrin monomers which spontaneously polymerise to a fibrin clot, which holds the collagen matrix tightly to the wound surface.
Danish: Fibrinogen omdannes til fibrinmonomere, som spontant polymeriserer til en fibrinklynge, der holder den kollagenholdige matrix fast tæt til såroverfladen.
English: Use only undamaged packages.
Danish: Brug kun ubeskadigede/uåbnede pakninger.
English: Fibrin sealants/haemostatics are metabolized in the same way as endogenous fibrin by fibrinolysis and phagocytosis.
Danish: Fibrin vævsklæber/hæmostatikum metaboliseres på samme måde som endogent fibrin ved fibrinolyse og fagocytose.
English: The use of TachoSil is restricted to experienced surgeons.
Danish: Anvendelse af TachoSil er forbeholdt erfarne kirurger.
English: Instructions Use TachoSil under sterile conditions only.
Danish: Instruktioner Brug kun TachoSil under sterile forhold.
English: Each sealant matrix is packed in a PET-GAG blister sealed with a coated PE foil.
Danish: Hver vævsklæbermatrix er pakket i en PET-GAG-blister forseglet med en overtrukken PE-folie.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may occur in rare cases in patients treated with fibrin sealants/haemostatics.
Danish: Overfølsomhed eller allergiske reaktioner (som kan inkludere angioødem, brændende og sviende fornemmelse ved applikationsstedet, bronkospasmer, kulderystelser, rødmen, generaliseret urticaria, hovedpine, udslæt, hypotension, letargi, kvalme, rastløshed, takykardi, trykken for brystet, prikkende fornemmelse, opkastning, hvæsende åndedræt) kan i sjældne tilfælde forekomme hos patienter behandlet med fibrinklæbere/hæmostatika.
English: Find out which size of TachoSil is needed.
Danish: Beslut først, hvilken størrelse TachoSil, der behøves.
English: It is recommended to remove the top part of the trocar prior to passing the pre-rolled TachoSil through the trocar.
Danish: Det anbefales at fjerne den øverste del af trokaren, før den prærullede TachoSil passerer gennem trokaren.
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg apoteketspersonal, hvordan du skal bortskaffe medicinrester.
English: The following adverse reactions have been reported with TachoSil during post marketing experience.
Danish: Følgende bivirkninger er blevet indberettet for TachoSil under anvendelse efter markedsføring.
English: The equine collagen antibodies that developed in some patients after TachoSil use were not reactive with human collagen.
Danish: De antistoffer mod hestekollagen, som nogle af patienterne dannede efter brug af TachoSil, var ikke reaktive over for humant kollagen.
English: The first controlled clinical trial investigating tissue sealing in lung surgery failed to document superiority over standard treatment measured by air leakage due to the inclusion of a large group of patients (53%) without air leakage.
Danish: Resultatet (måling af luftlækage) for den første kontrollerede kliniske undersøgelse, til påvisning af vævsforsegling ved lungekirurgi, var ikke signifikant bedre end standardbehandlingen på grund af inklusion af en stor gruppe patienter (53%) uden luftlækage.
English: A-4020 Linz, Austria
Danish: A-4020 Linz
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Danish: Dannelse af antistoffer over for bestanddele af fibrinklæbere/hæmostatika kan forekomme i sjældne tilfælde.
English: TachoSil is used under sterile conditions.
Danish: TachoSil anvendes under sterile forhold.
English: Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, gloves or adjacent tissues covered with blood.
Danish: Da kollagen har stor affinitet til blod kan TachoSil også hænge fast i instrumenter, handsker eller tilstødende væv, der er dækket af blod.
English: Specific data have not been obtained on the use of this product in gastrointestinal anastomoses surgery.
Danish: Der foreligger ikke specifikke data om anvendelse af TachoSil i forbindelse med anlæggelse af gastrointestinal anastomose.
English: Once the foil sachet is opened, TachoSil must be used immediately.
Danish: Når den ydre foliepakning er åbnet skal TachoSil anvendes øjeblikkeligt.
English: Intravascular administration is contraindicated.
Danish: Intravaskulær anvendelse er kontraindiceret.
English: This leaflet was last revised in {month/YYYY}
Danish: Denne indlægsseddel blev senest ændret måned ÅÅÅÅ
English: The fibrin is then cross linked by endogenous factor XIII, creating a firm, mechanically stable network with good adhesive properties and therefore provides sealing as well.
Danish: Derefter krydsbindes fibrinen via endogen faktor XIII til et solidt og mekanisk stabilt gitter med gode klæbegenskaber, som derved forsegler såroverfladen.
English: The doctor will place TachoSil on the internal organ to stop the bleeding or to seal the tissue.
Danish: TachoSil anbringes på det indre organ for at stoppe blødningen eller for at forsegle vævet.
English: TachoSil comes ready to use in sterile packages and must be handled accordingly.
Danish: TachoSil er pakket i brugsfærdige, sterile pakninger og skal behandles i overensstemmelse hermed.
English: The inner sterile blister must be opened in a sterile operating room area.
Danish: Den indre sterile blisterpakning skal åbnes under sterile forhold på operationsstuen.
English: However, in a clinical trial with TachoSil in hepatic surgery, in which patients were investigated for the development of antibodies, 26% of the 96 patients tested and treated with TachoSil developed antibodies to equine collagen.
Danish: I et klinisk studie med TachoSil anvendt ved leveroperationer, hvor patienterne blev undersøgt for dannelse af antistoffer, dannede 26% af de 96 patienter, som blev testet og behandlet med TachoSil, dog antistoffer mod hestekollagen.
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: En parvovirus B19-infektion kan være alvorlig for gravide kvinder (infektion hos fostret) og for individer med immundefekt eller forøget dannelse af røde blodlegemer (for eksempel hæmolytisk anæmi).
English: Each matrix contains per cm Human fibrinogen 5.5 mg Human thrombin 2.0 IU
Danish: Hver matrix indeholder pr. cm Human fibrinogen 5,5 mg Human thrombin 2,0 IE
English: In isolated cases, these reactions may progress to severe anaphylaxis.
Danish: I sjældne tilfælde kan disse reaktioner udvikle sig til alvorlig anafylaksi.
English: The size of the sealant matrix depends on the size of the wound.
Danish: Matrixens størrelse afhænger af sårets størrelse.
English: Takeda Austria GmbH St. Peter Strasse 25 A-4020 Linz Austria
Danish: Takeda Austria GmbH St. Peter Strasse 25 A-4020 Linz Østrig
English: All medicines based on human blood may uncommonly cause allergic reactions.
Danish: Al medicin, der fremstilles på basis af humant blod, kan medføre allergiske reaktioner, som er ikke almindelige bivirkninger.
English: In contact with physiological fluids, e.g. blood, lymph or physiological saline solution the components of the coating dissolve and partly diffuse into the wound surface.
Danish: Ved kontakt med fysiologiske væsker, som for eksempel blod, lymfe eller fysiologisk saltvand, vil komponenterne i belægningen opløses og diffundere delvist ind i såroverfladen.
English: However, the second study investigating tissue sealing in 299 patients (149 TachoSil, 150 standard surgical treatment) with demonstrated intraoperative air leakage showed the superiority of TachoSil compared to standard treatment.
Danish: Dog påviste den anden undersøgelse, der undersøgte vævsforsegling hos 299 patienter (149 TachoSil, 150 standard kirurgisk behandling), med demonstreret intraoperativ luftlækage, at TachoSil var signifikant bedre end standardbehandlingen.
English: For minimally invasive surgery, the pre-rolled matrix can be un-rolled with instruments at the site of application.
Danish: Ved minimal invasiv kirurgi kan den prærullede TachoSil rulles ud med instrumenter på applikationsstedet.
English: The quantity of TachoSil used depends on the size of the wound.
Danish: Antallet af TachoSil, som anvendes, afhænger af sårets størrelse.
English: Other medicines and TachoSil Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med TachoSil Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EUreferencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: When the active side comes into contact with fluids (such as blood, lymph or saline solution) the fibrinogen and the thrombin are activated and form a fibrin network.
Danish: Når den aktive side kommer i kontakt med væsker som for eksempel blod, lymfe eller saltvand, aktiveres fibrinogen og thrombin, og der dannes et fibringitter.
English: After removal of the pre-rolled TachoSil from the sterile package it should be applied immediately through the trocar without pre-moistening.
Danish: Når den prærullede TachoSil er taget ud af den sterile pakning, bør den appliceres straks gennem trokaren uden forudgående fugtning.
English: In isolated cases these allergic reactions may progress to anaphylactic shock.
Danish: I isolerede tilfælde kan disse tilstande udløse et anafylaktisk shock.
English: TachoSil must not be applied intravascularly.
Danish: TachoSil må ikke appliceres intravaskulært.
English: If more than one matrix is used they should overlap.
Danish: Hvis der skal bruges mere end én matrix til at dække såret, skal de overlappe hinanden.
English: Tabulated summary of adverse reactions
Danish: Tabuleret sammendrag af bivirkningerne
English: In the body TachoSil will dissolve and disappear completely.
Danish: Kroppen opløser TachoSil, og det forsvinder fuldstændigt.
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to the patients.
Danish: Når et lægemiddel fremstilles af blod og plasma, der stammer fra mennesker, tages der særlige forholdsregler for at forhindre overførsel af infektioner.
English: Thromboembolic complications may occur if the preparation is applied intravascularly (see section 4.4).
Danish: Tromboemboliske komplikationer kan forekomme, hvis præparatet anvendes intravaskulært (se pkt.
English: The outer aluminium foil sachet may be opened in a non-sterile operating area.
Danish: Den ydre aluminiumsfolie kan åbnes i ikke-sterile omgivelser.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Danish: De nævnte forholdsregler anses for tilstrækkelige til beskyttelse mod vira som HIV-virus, hepatitis B-virus og hepatitis C-virus (kappeklædte vira) og mod hepatitis A-virus (ikkekappeklædte vira).
English: TachoSil is a sealant matrix made of collagen, which is coated on the yellow side with human fibrinogen and human thrombin.
Danish: TachoSil er en vævsklæbermatrix fremstillet af kollagen, som på den gule side er overtrukket med human fibrinogen og human thrombin.
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Danish: Fremstilling af denne type medicin omfatter desuden processer, der inaktiverer og/eller fjerner vira fra blod og plasma.
English: The yellow side of TachoSil contains the active components: fibrinogen and thrombin.
Danish: På den gule side af TachoSil sidder de aktive indholdsstoffer fibrinogen og thrombin.
English: For smaller wounds, e.g. in minimally invasive surgery, the smaller sizes (4.8 x 4.8 cm or 3.0 x 2.5 cm) or the pre-rolled TachoSil (4.8 cm x 4.8 cm) is recommended.
Danish: Til mindre sår (f.eks. ved minimal invasiv kirurgi) anbefales de mindre størrelser 4,8 x 4,8 cm eller 3,0 x 2,5 cm) eller den prærullede TachoSil (4,8 cm x 4,8 cm).
English: Clinical studies demonstrating haemostasis were conducted in a total of 240 patients (119 TachoSil, 121 argon beamer) undergoing partial liver resection surgery and 185 patients (92 TachoSil, 93 standard surgical treatment) undergoing surgical resection of superficial renal tumour.
Danish: Hæmostase er demonstreret i kliniske studier med 240 patienter (119 TachoSil, 121 argon beamer), der har gennemgået operationer med partiel leverresektion og med 185 patienter (92 TachoSil, 93 standard kirurgisk behandling), der har gennemgået operation med resektion af overfladiske nyretumorer.
English: There were no adverse events attributable to the development of human fibrinogen or equine collagen antibodies.
Danish: Der forekom ingen bivirkninger, som kunne tilskrives dannelsen af antistoffer mod humant eller ekvint fibrinogen.
English: The doctor treating you will apply TachoSil during surgery.
Danish: Lægen vil anvende TachoSil på dig i forbindelse med en operation.
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Danish: Disse forholdsregler inkluderer omhyggelig udvælgelse af bloddonorer, for at udelukke smittebærere, samt undersøgelse af hver eneste portion blod for tegn på indhold af vira/infektioner.
English: A further controlled study in 119 patients (62 TachoSil, 57 haemostatic fleece) demonstrated sealing, haemostasis and suture support in patients undergoing cardiovascular surgery.
Danish: En yderligere kontrolleret undersøgelse med 119 patienter (62 TachoSil, 57 hæmostatisk fleece) påviste forsegling, hæmostase og støtte af sutur, hos patienter der fik foretaget karkirurgiske operationer.
English: TachoSil is used during surgery to stop local bleeding (haemostasis) and to seal tissue surfaces on internal organs.
Danish: TachoSil anvendes i forbindelse med operationer til at stoppe lokale blødninger og til at forsegle vævsoverflader på indre organer.
English: You may suffer hives, or a rash similar to nettle rash, chest discomfort or tightness, wheezing or low blood pressure.
Danish: Du kan få nældefeber, eller udslæt som ligner nældefeber, ubehag eller trykken i brystet, hvæsende vejrtrækning eller lavt blodtryk.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs (EMAs) hjemmeside http://www.ema.europa.eu/
English: Similar to comparable products or thrombin solutions, the sealant may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).
Danish: TachoSils klæbende egenskaber kan - i lighed med andre præparaterr indeholdende thrombinødelægges, hvis matrixen udsættes for eller kommer i forbindelse med opløsninger, der indeholder alkohol, iod eller tungmetaller (for eksempel antiseptiske opløsninger).
English: Hold down TachoSil with a gentle pressure for 3-5 minutes.
Danish: TachoSil holdes på plads med et let tryk i 3-5 minutter.
English: - The active substances are human fibrinogen (5.5 mg per cm 2) and human thrombin (2.0 IU per cm - The other ingredients are equine collagen, human albumin, riboflavin (E101), sodium chloride, sodium citrate (E331) and L-arginine-hydrochloride.
Danish: Pakningsstørrelser og yderligere oplysninger TachoSil indeholder: - Aktivestoffer: humanfibrinogen (5,5 mg/cm2) og human thrombin (2,0 IE/cm - Øvrige indholdsstoffer: ekvin kollagen, human albumin, riboflavin (E101), natriumchlorid, natriumcitrat (E331) og L-argininhydrochlorid.
English: Do not use this medicine after the expiry date which is stated on the label after “EXP”.
Danish: Brug ikke TachoSil efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Danish: Forholdsreglerne til beskyttelse mod vira kan være utilstrækkelige mod for eksempel Parvovirus B19 (ikke-kappeklædt virus).
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 ses især ved gentagen brug af præparatet flere gange til samme patient eller ved anvendelse til patienter med kendt overfølsomhed over for et eller flere af indholdsstofferne i præparatet.
English: Therefore, TachoSil should be administered to pregnant and breastfeeding women only if clearly needed.
Danish: På dette grundlag bør TachoSil kun anvendes til gravide eller ammende kvinder på tvingende indikation.
English: After removal of the conventional, flat TachoSil from the sterile package it should be pre-moistened in saline solution and then applied immediately.
Danish: Når den konventionelle, flade TachoSil er taget ud af den sterile pakning, bør den fugtes med sterilt fysiologisk saltvand og anvendes umiddelbart herefter.
English: Do not use intravascularly.
Danish: Må ikke anvendes intravaskulært.
English: To make sure that TachoSil does not cling to the moistened glove or swab, and loosens itself from the wound, TachoSil can be held down at one end e.g. by using a pair of forceps.
Danish: For at sikre at TachoSil ikke løsner sig igen på grund af vedhæftning til den fugtede handske eller gazekompres, kan den holdes fast i den ene ende med for eksempel et par tænger.
English: Equine collagen, human albumin, riboflavine (E101), sodium chloride, sodium citrate (E331), L-arginine-hydrochloride
Danish: Ekvin kollagen, human albumin, riboflavin (E101), natriumchlorid, natriumcitrat (E331), L- argininhydrochlorid
English: During the following time TachoSil will dissolve and disappear.
Danish: TachoSil vil efterfølgende opløses og forsvinde i kroppen.
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Danish: Tegn på allergiske overfølsomhedsreaktioner kan være nældefeber og generaliseret urticaria, trykken for brystet, hvæsende vejrtrækning, hypotension og anafylaksi.
English: The un-rolled TachoSil should then be moistened at the site of application with a moist pad and held in place under gentle pressure for 3-5 minutes.
Danish: Den udrullede TachoSil skal så fugtes på applikationsstedet med et fugtet gazekompres og holdes på plads ved et let tryk i 3-5 minutter.
English: Equine collagen Human albumin Riboflavine (E101) Sodium chloride Sodium citrate (E331) L-arginine-hydrochloride.
Danish: Ekvint kollagen Humant albumin Riboflavin (E 101) Natriumchlorid Natriumcitrat (E331) L-argininhydrochlorid
English: EU/1/04/277/001 1 matrix of 9.5 cm x 4.8 cm EU/1/04/277/002 2 matrices of 4.8 cm x 4.8 cm EU/1/04/277/003 1 matrix of 3.0 cm x 2.5 cm EU/1/04/277/004 5 matrices of 3.0 cm x 2.5 cm EU/1/04/277/005 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Danish: EU/1/04/277/001 1 matrix på 9,5 cm x 4,8 cm EU/1/04/277/002 2 matrixer på 4,8 cm x 4,8 cm EU/1/04/277/003 1 matrix på 3,0 cm x 2,5 cm EU/1/04/277/004 5 matrixer på 3,0 cm x 2,5 cm EU/1/04/277/005 1 prærullet matrix på 4,8 cm x 4,8 cm
English: Do not store above 25 °C.
Danish: Må ikke opbevares ved temperaturer over 25°C.
English: Wipe the wound surface gently before placing TachoSil on the wound.
Danish: Tør såroverfladen let, før TachoSil placeres på såret.
English: What you need to know before TachoSil is used
Danish: Det skal du vide, før du begynder at bruge TachoSil
English: If you get any side effects, talk to your doctor.
Danish: Hvis du oplever nogle af disse symptomer, skal du straks kontakte din læge.
English: In clinical trials, the individual dosages have typically ranged from 1-3 units (9.5 cm x 4.8 cm); application of up to 10 units has been reported.
Danish: Den individuelle dosering har i kliniske studier typisk varieret fra 1-3 enheder (9,5 cm x 4,8 cm).
English: This can be avoided by cleansing surgical instruments, and gloves and adjacent tissues before application.
Danish: For at undgå dette kan instrumenter, handsker og tilstødende væv rengøres, inden TachoSil tages i anvendelse.
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 TachoSil på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: TachoSil should be used immediately after opening the inner sterile cover.
Danish: TachoSil bør anvendes straks efter åbning af den sterile indre pakning.
English: • to use TachoSil soon after opening the outer aluminium cover.
Danish: • at anvende TachoSil hurtigst muligt efter åbning af den ydre alufoliepakning.
English: 5.1 Pharmacodynamic properties
Danish: 5.1 Farmakodynamiskeegenskaber