FrancophonIA/ELRC3.0 huggingface dataset:
English: The use of EVICEL is restricted to experienced surgeons who have been trained in the use of EVICEL.
Danish: EVICEL må kun anvendes af erfarne kirurger, der er blevet uddannet i brugen af EVICEL.
English: As with any protein product, allergic type hypersensitivity reactions are possible.
Danish: Som ved alle proteinprodukter kan der forekomme allergilignende overfølsomhedsreaktioner.
English: Before use, the product must reach 20-30°C.
Danish: Før brug skal produktets temperatur være 20-30°C.
English: The volume of EVICEL to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
Danish: Applikationshyppigheden og den mængde EVICEL, der skal påføres, bør altid være i overensstemmelse med det grundlæggende kliniske behov hos den pågældende patient.
English: The doctor treating you will administer EVICEL during surgery.
Danish: Den læge, der behandler dig, anvender EVICEL under operationen.
English: After local application, absorption of thrombin into the plasma is slow and consists principally of thrombin degradation products which are eliminated.
Danish: Absorption af trombin i plasma efter lokal applikation er langsom og består hovedsageligt af nedbrydningsprodukter fra trombinet, som elimineres.
English: In controlled clinical trials in vascular surgery, the individual dosage used was up to 4 ml; for suture line sealing in dura mater closure, doses of up to 8 ml were used, whereas in retroperitoneal or intra-abdominal surgery the individual dosage used was up to 10 ml.
Danish: I kontrollerede kliniske forsøg inden for karkirurgi har de individuelle doser været op til 4 ml, til forsegling af suturlinjen ved lukning af dura mater blev doser op til 8 ml anvendt, mens individuel dosis i retroperitoneal eller intraabdominal kirurgi har været op til 10 ml.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Danish: • Når risikostyringssystemet ændres, særlig som følge af at der modtages nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Studies performed in bacteria to determine mutagenicity were negative for thrombin alone, Biological Active Component (containing fibrinogen, citrate, glycine, tranexamic acid, and arginine hydrochloride), TnBP alone, and Triton X-100 alone at all concentrations tested.
Danish: Studier udført med bakterier til bestemmelse af mutagenicitet var negative hvad angår trombin alene, den biologisk aktive komponent (indeholdende fibrinogen, citrat, glycin, tranexamsyre og argininhydrochlorid), TnBP alene og Triton X-100 alene ved alle testede koncentrationer.
English: Human Fibrinogen and Human Thrombin: Omrix Biopharmaceuticals Ltd.
Danish: Humant fibrinogen og humant trombin: Omrix Biopharmaceuticals Ltd.
English: It is strongly recommended that every time EVICEL 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 kraftigt at registrere navn og batchnummer for produktet, hver gang EVICEL anvendes til en patient, for at kunne fastholde forbindelsen mellem patienten og den anvendte batch af produktet.
English: The instructions for use are also described in the healthcare professionals package leaflet part.
Danish: Reglerne for brug er også beskrevet i den del af indlægssedlen, der er henvendt til sundhedspersonale.
English: • When EVICEL is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue.
Danish: • Når EVICEL påføres under kirurgiske indgreb, skal kirurgen sikre, at det kun påføres vævsoverfladen.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Danish: For instruktioner i klargøring af lægemidlet før administration, se pkt.
English: EVICEL can also be used to support the watertight closure of the cerebral envelopes (dura mater) during neurosurgery when other surgical techniques are insufficient.
Danish: EVICEL kan også anvendes som støtte til vandtæt lukning af hjernehinden (dura mater) under neurokirurgi, når andre kirurgiske teknikker er utilstrækkelige.
English: A non-interventional post-authorisation safety study was conducted which involved 300 patients undergoing vascular surgery during which EVICEL was used.
Danish: Et ikke-interventionelt sikkerhedsstudie blev gennemført efter udstedelse af markedsføringstilladelse og omfattede 300 patienter, der gennemgik karkirurgi, under hvilken EVICEL blev anvendt.
English: The fibrinogen and thrombin components are stable at room temperature for up to 24 hours.
Danish: Fibrinogen- og trombinkomponenterne er stabile ved stuetemperatur i op til 24 timer.
English: Children and adolescents Data are too limited to support the safety and effectiveness of EVICEL in children and adolescents.
Danish: Børn og unge Data er for begrænsede til at kunne understøtte sikkerheden og effekten af EVICEL hos børn og unge.
English: All concentrations of the combination of TnBP and Triton X-100 also tested negative in assays performed to determine mammalian cell mutagenicity, chromosomal aberrations and micronuclei induction.
Danish: Alle koncentrationer af kombinationen af TnBP og Triton X-100 testede også negativt i analyser udført for at bestemme mutagenicitet for pattedyr, kromosomafvigelser og induktion af mikronuclei.
English: Other ingredients are:
Danish: Øvrige indholdsstoffer:
English: To be used as two-component product with supplied device.
Danish: Anvendes som tokomponentprodukt med den medfølgende anordning.
English: EVICEL is applied in adults during surgical operations to reduce bleeding and oozing during and after the operation.
Danish: EVICEL påføres hos voksne for at dæmpe blødninger og siveblødning under og efter operationer.
English: EVICEL Applicator Device
Danish: EVICEL applikator anordning
English: Pressure regulator to be used
Danish: Trykregulator, der skal anvendes
English: If these symptoms occur, the administration should be discontinued immediately.
Danish: Hvis disse symptomer opstår, skal administrationen straks afbrydes.
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 vurdere absorptionen og eliminationen af trombin påført resektionsfladen af leveren efter partiel hepatektomi.
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: Standardforholdsreglerne til forebyggelse af infektioner forårsaget af brugen af lægemidler fremstillet af blod eller plasma fra mennesker omfatter: udvælgelse af donorer, screening af de enkelte donationer og plasmareserver for infektionsmarkører samt effektive fremstillingstrin til inaktivering/fjernelse af virus.
English: The MAH shall ensure that all users of the spray application of this product are provided with: - labels for the pressure regulator that inform about the correct pressures and distances in open and laparoscopic procedures - a warning card that informs about the correct pressures and distances for the spray application for open and laparoscopic procedures - a tag, to be placed on the device air hose, which provides instructions for use.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle brugere, der sprayer/applicerer dette produkt, er forsynet med: - mærkater til trykregulatoren, der informerer om de korrekte tryk og afstande i åbne og laparoskopiske indgreb - et advarselskort, der informerer om de korrekte tryk og afstande for spray-applikation i åbne og laparoskopiske indgreb - en mærkeseddel, der skal anbringes på apparatets luftslange, og hvoraf brugsanvisningen fremgår.
English: For storage conditions after thawing of the medicinal product, see section 6.3.
Danish: For opbevaringsbetingelser efter optøning af lægemidlet, se pkt.
English: EVICEL spray application should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy.
Danish: Spray-applikation af EVICEL må kun anvendes, hvis det er muligt nøjagtigt at bedømme sprayafstanden, især under laparoskopi.
English: EVICEL must not be injected into tissue or blood vessels because it would cause clots which could be fatal.
Danish: EVICEL må ikke sprøjtes ind i væv eller blodkar, da dette kan forårsage blodpropper, som kan være dødelige.
English: • As with any product containing proteins, allergic-type hypersensitivity reactions are possible.
Danish: • Som ved al medicin, der indeholder proteiner, kan der forekomme allergiske overfølsomhedsreaktioner.
English: The vials must be stored in an upright position.
Danish: Hætteglassene skal opbevares i opretstående stilling.
English: The measures taken are considered effective for enveloped viruses such as HIV, hepatitis C virus, and hepatitis B virus, and for the non-enveloped hepatitis A virus.
Danish: Forholdsreglerne anses som effektive for kappeklædte virus som hiv, hepatitis C-virus og hepatitis Bvirus samt for den ikke-kappeklædte hepatitis A-virus.
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: Sikkerheden ved fibrinklæbere/hæmostatika hos mennesker under graviditet eller under amning er ikke påvist i kontrollerede kliniske forsøg.
English: 6.6 Special precautions for disposal and other handling
Danish: 6.6 Særlige forholdsregler ved bortskaffelse og anden håndtering.
English: Adequate data are not available to support the use of this product in tissue gluing, application through a flexible endoscope for treatment of bleeding, or in gastrointestinal anastomoses.
Danish: Der foreligger ikke tilstrækkelige data til at understøtte brug af denne vævsklæber til behandling af blødning eller til gastrointestinal anastomose ved applikation gennem et fleksibelt endoskop.
English: EVICEL is available in the following pack sizes: 2 x 1 ml, 2 x 2 ml, and 2 x 5 ml.
Danish: EVICEL fås i følgende pakningsstørrelser: 2 x 1 ml, 2 x 2 ml og 2 x 5 ml.
English: The new expiry date at 2°C-8C should be noted on the carton but should not exceed the expiry date printed by the manufacturer on the carton and label.
Danish: Den nye udløbsdato under opbevaring ved 2 °C - 8 C skal noteres på kartonen, men den må ikke overskride den udløbsdato, som fremstilleren har trykt på kartonen og etiketten.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Danish: Nedenstående tabel viser bivirkninger efter MedDRA-systemorganklassifikation (systemorganklasse og foretrukken term).
English: • In accordance with the European Commission decision on the procedure EMEA/H/C/000898/A20/0018 to mitigate the risk of potentially life threatening air/gas embolism when the product is sprayed at higher than recommended pressures and/or in close proximity to the tissue surface, the MAH shall ensure that: - When EVICEL is sprayed using pressurized gas, the gas should be carbon dioxide because the greater solubility of carbon dioxide in blood reduces the risk of embolism.
Danish: • Yderligere risikominimeringsforanstaltninger I overensstemmelse med Europa-Kommissionens afgørelse af denne procedure (EMEA/H/C/000898/A20/0018) om at mindske risikoen for potentielt livstruende luft/gasemboli, hvis produktet sprayes hurtigere end det anbefalede tryk og/eller tæt på vævsoverfladen, skal indehaveren af markedsføringstilladelsen sikre, at: - Når EVICEL sprayes under tryk, skal gassen være CO2, fordi CO2's større opløselighed i blodet reducerer risikoen for emboli - EVICEL ikke sprayes ved hjælp af et endoskop, hvis den anbefalede minimumsafstand fra vævet ikke kan overholdes
English: Data are too limited to support the safety and effectiveness of EVICEL in children and adolescents.
Danish: Data er for begrænsede til at understøtte sikkerheden ved og effekten af EVICEL hos børn og unge.
English: Therefore, the product should be administered to pregnant and breast-feeding women only if clearly needed.
Danish: Derfor bør produktet kun anvendes til gravide og ammende kvinder på tvingende indikation.
English: POB 888, Kiryat Ono 5510801 Israel
Danish: Kiryat Ono 5510801
English: Omrix Biopharmaceuticals Ltd Pharmacovigilance Department Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat Gan 5262000, Israel Tel: +972-3-5316512
Danish: Sheba Hospital, Tel Hashomer Ramat Gan 5262000, Israel Tlf.: +972-3-5316512
English: EVICEL must be sprayed using pressurised CO2 only.
Danish: EVICEL må kun sprayes på ved hjælp af CO2 under tryk.
English: • Use of EVICEL during neurosurgery in patients who are also being treated with implants or with dural patches has not been evaluated in clinical studies.
Danish: • Anvendelse af EVICEL under neurokirurgi hos patienter, der også bliver behandlet med implantater eller durale patches, er ikke undersøgt i kliniske studier
English: Discard unused product after 24 hours at room temperature.
Danish: Kassér ubrugt lægemiddel efter 24 timer ved stuetemperatur.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Danish: Dannelse af antistoffer over for komponenter i fibrinklæber/hæmostatika kan forekomme i sjældne tilfælde.
English: The application device should be stored at room temperature, separately from the fibrinogen and thrombin.
Danish: Applikatoren skal opbevares ved stuetemperatur, adskilt fra fibrinogen og trombin.
English: Fibrin sealants/haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Danish: Fibrinklæbere/hæmostatika metaboliseres på samme måde som endogent fibrin ved fibrinolyse og fagocytose.
English: Post procedural haematoma Post-operative wound complication
Danish: Hæmatom efter behandling Post-operativ sårkomplikation
English: • surgery to the brain or spinal cord except for support of watertight closure of cerebral envelopes (dura mater)
Danish: • til kirurgi i hjernen og rygmarven undtagen til støtte af vandtæt lukning af hjernehinden
English: Of 135 patients undergoing retroperitoneal and intra-abdominal surgery who were included in the controlled study of EVICEL, 4 patients treated with EVICEL were aged 16 years or younger.
Danish: Ud af 135 patienter, der fik foretaget retroperitoneal og intraabdominal kirurgi, som var inkluderede i det kontrollerede studie med EVICEL, var 4 patienter, der blev behandlet med EVICEL, 16 år eller yngre.
English: Plasma Fractionation Institute (Omrix-PFI) MDA Blood Bank
Danish: Plasma Fractionation Institute (Omrix-PFI)
English: The pressure regulator should be used in accordance with the manufacturer's instruction.
Danish: Trykregulatoren skal anvendes i overensstemmelse med producentens vejledning.
English: Omrix Biopharmaceuticals Ltd. Jerusalem Plant (Omrix-JP) 5 Kiryat Hamada St., Ramot Meir Building Har-Hotzvim P.O.B.
Danish: Omrix Biopharmaceuticals Ltd. Jerusalem Plant (Omrix-JP) 5 Kiryat Hamada St.
English: However, since EVICEL is used during a surgical operation, if you are pregnant or breast-feeding, you should discuss the overall risks of the operation with your doctor.
Danish: Eftersom EVICEL anvendes under en operation, bør du imidlertid drøfte de overordnede risici ved operationen med lægen, hvis du er gravid eller ammer.
English: Clear or slightly opalescent solutions.
Danish: Klare eller let opaliserende opløsninger.
English: • sealing in transphenoidal and otoneurosurgical procedures
Danish: • til forsegling ved transfenoidale og otoneurokirurgiske indgreb
English: • The bleeding should be controlled before EVICEL is used to seal the dural suture line.
Danish: • Blødningen bør være under kontrol, inden EVICEL anvendes til at forsegle den durale suturlinje
English: Omrix Biopharmaceuticals N.V. Leonardo Da Vinci Laan 15 B-1831 Diegem
Danish: Leonardo Da Vinci Laan 15 B-1831 Diegem
English: The vials can be stored at room temperature for up to 24 hours.
Danish: Hætteglassene kan opbevares ved stuetemperatur i op til 24 timer.
English: The new expiry date at 2C-8C should be noted on the carton but should not exceed the expiry date printed by the manufacturer on the carton and label.
Danish: 6.3.Den nye udløbsdato under opbevaring ved 2 C - 8 C skal noteres på kartonen, men den må ikke overskride den udløbsdato, som fremstilleren har trykt på kartonen og etiketten.
English: Other side effects which were reported to be common during clinical trials with EVICEL (i.e., may affect up to 1 in 10 people) included meningitis, and accumulation of CSF fluid in the brain cavities (hydrocephalus).
Danish: Andre bivirkninger, der blev rapporteret som almindelige i de kliniske forsøg med EVICEL (dvs. kan påvirke op til 1 ud af 10 mennesker), omfattede meningitis og ophobning af cerebrospinalvæske i hjernen (hydrocefalus, ”vand i hovedet”).
English: The use of EVICEL as a sealant in transphenoidal and otoneurosurgical procedures has not been studied.
Danish: Anvendelse af EVICEL som vævsklæber ved transfenoidale og otoneurokirurgiske indgreb er ikke undersøgt.
English: Before use, the product must reach 20°C-30°C.
Danish: Før brug skal produktets temperatur nå op på 20 °C - 30 °C.
English: The pressure regulator should be used in accordance with the manufacturer's instructions.
Danish: Trykregulatoren skal anvendes i overensstemmelse med fremstillerens vejledning.
English: • EVICEL should not be used in endoscopic surgery.
Danish: • EVICEL må ikke anvendes ved endoskopisk kirurgi.
English: • It is not known whether radiation therapy could affect the effectiveness of fibrin sealant when used for suture line sealing during neurosurgery.
Danish: • Det vides ikke, om strålebehandling kan påvirke fibrinvævsklæberens effektivitet, når den anvendes til forsegling af suturlinjen under neurokirurgi
English: An application device and appropriate accessory tips are supplied separately.
Danish: En applikator og passende, tilhørende spidser leveres separat.
English: For safety with respect to transmissible agents, see section 4.4.
Danish: 4.4 vedrørende sikkerhed i forbindelse med overførbare agenser.
English: The efficacy of EVICEL for suture line sealing in dura mater closure was demonstrated in 139 patients (89 treated with EVICEL and 50 controls) undergoing craniotomy/craniectomy procedures.
Danish: EVICELs effektivitet til forsegling af suturlinjen ved lukning af dura mater blev vist hos 139 patienter (89 behandlet med EVICEL og 50 kontroller), der gennemgik kraniotomi/kraniektomi-indgreb.
English: Laparoscopic procedures
Danish: Laparoskopisk indgreb
English: For spray application see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue per surgical procedure and length of applicator tip.
Danish: 4.4 og 6.6 for specifikke anbefalinger vedrørende påkrævet tryk og afstand til væv i forhold til det kirurgiske indgreb samt længde af applikationsspids.
English: Spray devices and accessory tips provide instructions for use with recommendations for pressure ranges and proximity to tissue surface, which should be carefully followed.
Danish: Vejledningerne for spray-anordninger og tilhørende spidser giver anbefalinger for trykinterval og afstand til vævsoverflade, og skal følges omhyggeligt.
English: As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Danish: I løbet af sårhelingsprocessen induceres øget fibrinolytisk aktivitet af plasmin, og en nedbrydning af fibrin til fibrinnedbrydningsprodukter initieres.
English: Calcium ions are required for both, the conversion of fibrinogen and the crosslinking of fibrin.
Danish: Calciumioner er nødvendige for både omdannelse af fibrinogen og tværbinding af fibrin.
English: Store in a freezer at or below -18C.
Danish: Opbevares i dybfryser ved eller under -18C.
English: Side effects which were uncommon during clinical trials with EVICEL (i.e., may affect up to 1 in 100 people) included infection, blood accumulation (haematoma), swelling, decreased haemoglobin, and post-operative wound complications (including bleeding or infection).
Danish: Bivirkninger, der var ikke almindelige i de kliniske forsøg med EVICEL (dvs. kan påvirke op til 1 ud af 100 mennesker), omfattede infektion, ophobning af blod (hæmatom), hævelse, nedsat hæmoglobin og sårkomplikationer efter operationen (inklusive blødning eller infektion).
English: However, 3 serious adverse events (SAE) (one abdominal abscess in the EVICEL group and one abdominal and one pelvic abscess in the control group) were considered by the Sponsor to be possibly related to study treatment.
Danish: 3 alvorlige uønskede hændelser (en abdominal absces i EVICEL-gruppen og en abdominal og en bækkenabsces i kontrolgruppen) blev anset for muligvis at være relateret til forsøgsbehandlingen ifølge den medicinske gennemgang, der blev foretaget af sponsor.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those not prescribed.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The concomitant use of EVICEL for dural suture line sealing with implants from synthetic materials or dural patches has not been evaluated in clinical studies.
Danish: Samtidig anvendelse af EVICEL til forsegling af den durale suturlinje og implantater fra syntetiske materialer eller durale patches er ikke blevet evalueret i kliniske studier.
English: 5 How to store EVICEL Contents of the pack and other information
Danish: 5 Opbevaring af EVICEL Pakningsstørrelser og yderligere oplysninger
English: The fibrin monomers aggregate and form a fibrin clot.
Danish: Fibrinmonomererne aggregerer og danner en fibrinprop.
English: EVICEL is also indicated in adults as suture support for haemostasis in vascular surgery and for suture line sealing in dura mater closure.
Danish: EVICEL er også indiceret hos voksne som suturunderstøttelse af hæmostase ved karkirurgi og til forsegling af suturlinjen ved lukning af dura mater.
English: When applying EVICEL using a spray device, be sure to use a pressure and a distance from tissue within the ranges recommended by the manufacturer:
Danish: Ved applikation af EVICEL ved brug af en spray-anordning skal man sørge for at anvende et tryk og en afstand fra vævet, der er inden for de områder, der anbefales af producenten:
English: Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Danish: Overdreven koageltykkelse kan interferere negativt med produktets effektivitet og sårhelingsprocessen.
English: When applying EVICEL using a spray device, it has to be ensured that the pressure and the distance from the tissue are within the ranges recommended by the marketing authorisation holder of this product, as given in the following table:
Danish: Når EVICEL appliceres med en spray-anordning, skal det sikres, at trykket og afstanden fra vævet er indenfor de intervaller, som indehaveren af markedsføringstilladelsen anbefaler, og som angives i følgende tabel.
English: Life-threatening air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer EVICEL.
Danish: Livstruende luft- eller gasemboli er forekommet ved brug af spray-anordninger, der har trykregulator, til at administrere EVICEL.
English: EVICEL must not be used for sealing the suture line in dura mater if there are gaps of greater than 2 mm after suturing.
Danish: EVICEL må ikke anvendes til forsegling af suturlinjen i dura mater, hvis der er mellemrum på over 2 mm efter suturering.