FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Danish: Hovedpine og influenzalignende symptomer som feber, træthed, svaghed, døsighed, kulderystelser samt knogle-, led- og/eller muskelsmerter.
English: 0.5 mg/dl or 44 μmol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
Danish: - Øgning på 1,0 mg/dl eller 88 μmol/l hos patienter med abnorm kreatinin ved baseline
English: BATCH NUMBER
Danish: NR NR NR
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Danish: Sjælden (forekommer hos op til 1 ud af 1.000 patienter):
English: - Keep Zoledronic acid Mylan out of the sight and reach of children.
Danish: Opbevar Zoledronsyre Mylan utilgængeligt for børn.
English: Component of a multipack.
Danish: Emballagetype og pakningsstørrelser
English: Pain in extremities, arthralgia, musculoskeletal pain
Danish: Smerte i ekstremiteter, artralgi, muskuloskeletal smerte Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
English: Blister (OPA/Alu /PVC-Alu) 10 x 1 tablets (unit dose)
Danish: Blisterpakning (OPA/alu/PVC-alu)
English: Date of first authorisation: 06 October 2008 Date of latest renewal: 06 October 2013
Danish: Dato for første tilladelse: 6.oktober 2008 Dato for seneste fornyelse: 6. oktober 2013
English: The application can be repeated, if necessary.
Danish: Applikationen kan om nødvendigt gentages.
English: • At the request of the European Medicines Agency
Danish: • På anmodning fra Det Europæiske Lægemiddelagentur
English: Of these, 2 were children aged 2 and 5 years and 2 were adolescents of 16 years.
Danish: 2 af disse var børn på 2 og 5 år, og 2 var unge på 16 år.
English: The temperature must not exceed 37°C.
Danish: Temperaturen må ikke overstige 37 °C.
English: Do not re-freeze.
Danish: Må ikke nedfryses igen.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I overensstemmelse med artikel 114 i direktiv 2001/83/EF skal den officielle batchfrigivelse foretages af et statslaboratorium eller af et laboratorium, der er udpeget til dette formål.
English: • The use of EVICEL has not been studied in the following procedures, and there is therefore no information to show that it would be effective in these procedures:
Danish: • Anvendelsen af EVICEL er ikke blevet undersøgt i følgende procedurer, og der er derfor ingen oplysninger, der viser om det er effektivt ved disse procedurer:
English: The frequency of all of these effects was common.
Danish: Hyppigheden af disse bivirkninger var almindelig.
English: An updated RMP should be submitted
Danish: En opdateret RMP skal fremsendes
English: If you feel unwell tell your doctor immediately, even if your symptoms are different from those just described.
Danish: Hvis du føler dig utilpas, så fortæl det straks til lægen, også selvom dine symptomer er forskellige fra dem, der lige er blevet beskrevet.
English: Such substances should be removed to the greatest possible extent before applying the product.
Danish: Sådanne stoffer bør så vidt muligt fjernes, før produktet påføres.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis datoerne for fremsendelse af en PSUR og opdateringen af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: At the Cmax, the plasma concentration represented only 1-2% of the applied dose.
Danish: Ved Cmax udgjorde plasmakoncentrationen kun 1-2% af den påførte dosis.
English: If the tag is provided as part of the medicinal product, it should be incorporated in the product information via a variation procedure
Danish: Hvis mærkesedlen leveres som en del af lægemidlet, skal den inkorporeres i produktinformationen via en variationsprocedure.
English: No data are currently available for ages younger than 2 years.
Danish: Der foreligger på nuværende tidspunkt ingen data om patienter på under 2 år.
English: Both syringes should be filled with equal volumes, and should not contain air bubbles.
Danish: De to sprøjter skal fyldes med lige store mængder og må ikke indeholde luftbobler.
English: The exact content and format of the educational material and educational programme including communication media, distribution modalities, and any other aspects of the programme, shall be agreed with the National Competent Authority.
Danish: Undervisningsmaterialets og undervisningsprogrammets præcise indhold og form, herunder kommunikationsmedier, distributionsmetoder og andre aspekter af programmet skal aftales med den kompetente nationale myndighed.
English: Neurobehavioral observations for 14±1 days showed no abnormal findings.
Danish: Neuroadfærdsmæssige observationer i 14±1 dage viste ingen anormale resultater.
English: Frequencies have been evaluated according to the following convention: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheder er blevet evalueret i henhold til 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: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du bliver behandlet med dette lægemiddel, da den indeholder vigtige oplysninger.
English: The frequency of the type of event is not known (cannot be estimated from available data).
Danish: Hyppigheden af denne bivirkning er ikke kendt (kan ikke vurderes ud fra forhåndenværende data).
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: Den dosis, der skal anvendes, bestemmes af variabler, herunder, men ikke begrænset til, typen af det kirurgiske indgreb, områdets størrelse og den påtænkte applikationsmåde samt antallet af applikationer.
English: Uncommon Uncommon Uncommon Uncommon Uncommon
Danish: Ikke almindelig Ikke almindelig Ikke almindelig Ikke almindelig Ikke almindelig
English: The requirements for submission of periodic safety update reports for this medicinal product are 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 periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD liste) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Analysis of cerebrospinal fluid did not reveal major signs of inflammation.
Danish: Analyse af cerebrospinalvæske viste ingen betydelige tegn på inflammation.
English: If you experience any of the above mentioned symptoms, or any other symptoms related to your surgery, please contact your doctor or surgeon immediately.
Danish: Hvis du oplever nogen af de ovenfor nævnte symptomer eller nogen andre symptomer relateret til din operation, skal du kontakte din læge eller kirurgen med det samme.
English: EVICEL comes in sterile packages and therefore it is important to use only undamaged packages which have not been opened (post-sterilisation is not possible).
Danish: EVICEL leveres i sterile pakninger, og det er derfor vigtigt kun at anvende ubeskadigede pakninger, som ikke har været åbnet (sterilisering efter åbning er ikke muligt).
English: In isolated cases, these reactions have progressed to severe anaphylaxis.
Danish: I enkeltstående tilfælde har disse reaktioner udviklet sig til svær anafylaksi.
English: The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
Danish: Den mængde af produktet, der initialt skal appliceres på et valgt anatomisk sted eller en valgt måloverflade, skal være tilstrækkelig til at dække det påtænkte applikationsområde fuldstændigt.
English: The active substances are as follows:
Danish: De aktive stoffer er følgende:
English: The vials should be thawed in one of the following ways:
Danish: Hætteglassene skal optøs på en af følgende måder:
English: The healthcare professionals will record the name and batch number of the medicinal product in order to trace any possible infection source.
Danish: Sundhedspersonalet noterer navn og batchnummer på medicinen for at kunne spore mulige infektionskilder.
English: No major macroscopic signs of local intolerance and no treatment-related macroscopic findings were observed.
Danish: Der blev ikke observeret betydelige makroskopiske tegn på lokal intolerance og heller ingen behandlingsrelaterede makroskopiske resultater.
English: • Pressure regulators do not exceed the maximum pressure of 1.7 bars for spraying EVICEL, and contain labels stating the recommended pressure and distance.
Danish: • Trykregulatorer ikke overstiger det maksimale tryk på 1,7 bar for sprayning af EVICEL og indeholder mærkater med angivelse af det anbefalede tryk og den anbefalede afstand.
English: No allergic reactions have so far been reported in patients treated with EVICEL.
Danish: Der er indtil nu ikke set allergiske reaktioner hos patienter, som har fået behandling med EVICEL.
English: • If you are hypersensitive (allergic) to products made from human blood or to any of the other ingredients of EVICEL (listed in section 6).
Danish: • Hvis du er overfølsom (allergisk) over for medicin, der er fremstillet af blod fra mennesker, eller over for et af de øvrige indholdsstoffer i EVICEL (angivet i punkt 6).
English: Component 2 Human thrombin
Danish: Komponent 2 Humant trombin
English: EVICEL forms a clear film over the area of application.
Danish: EVICEL danner en gennemsigtig film over applikationsområdet.
English: 800 - 1,200 IU 1,600 - 2,400 IU 4,000 - 6,000 IU
Danish: 800-1.200 IE 1.600-2.400 IE 4.000-6.000 IE
English: This device allows equal amounts of the two components of EVICEL to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to have its optimal effect.
Danish: Applikatoren gør det muligt at påføre lige store mængder af de to komponenter af EVICEL på samme tid og sikrer, at de blandes ligeligt, hvilket er vigtigt for, at vævsklæberen kan have optimal effekt.
English: Factor XIIIa, which is activated from Factor XIII by thrombin, crosslinks fibrin.
Danish: Faktor XIIIa, som aktiveres fra faktor XIII af trombin, tværbinder fibrin.
English: The frequency of the effects listed above was common (may affect up to 1 in 10 people).
Danish: Hyppigheden af bivirkningerne angivet ovenfor var almindelig (kan påvirke op til 1 ud af 10 personer).
English: The following side effects which occurred during clinical studies were considered to be related to the use of EVICEL:
Danish: Følgende bivirkninger, som forekom i kliniske studier, ansås for at være forbundet med brugen af EVICEL:
English: At 30 days post-operatively the incidence of SSIs was similar between the two treatment groups.
Danish: 30 dage postoperativt var incidensen af SSI den samme i de to behandlingsgrupper.
English: Fibrin sealants in general may, in rare cases (up to 1 patient in 1,000 people), cause an allergic reaction.
Danish: Generelt kan fibrinklæbere i sjældne tilfælde (op til 1 ud af 1.000 patienter) forårsage en allergisk reaktion.
English: Life-threatening thromboembolic complications may occur if the product is unintentionally applied intravascularly.
Danish: Der kan opstå livstruende tromboemboliske komplikationer, hvis produktet utilsigtet anvendes intravaskulært.
English: The product should only be reconstituted and administered according to the instructions and with the devices recommended for this product.
Danish: Produktet må kun rekonstitueres og påføres i henhold til instruktionerne og med de anordninger, der anbefales for dette produkt.
English: The date on which refrigerator storage was started should be marked on the carton in the space provided.
Danish: Datoen for påbegyndelse af opbevaring i køleskab skal noteres på pakningen i det relevante felt.
English: Pharmacotherapeutic group: local haemostatics, combinations, ATC code: B02BC30
Danish: Farmakoterapeutisk klassifikation: hæmostatica til lokal brug, kombinationer, ATC-kode: B02BC30
English: However, for some procedures (e.g., liver traumata) larger volumes may be required.
Danish: Ved nogle indgreb (f.eks. levertraume) kan der være behov for større mængder.
English: What EVICEL contains
Danish: EVICEL indeholder
English: I-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: I-trombin blev det påvist, at der skete en langsom absorption af biologisk inaktive peptider, som opstod ved nedbrydningen af trombin, og at Cmax i plasma blev opnået efter 6-8 timer.
English: At the end of this period the product has to be used or discarded.
Danish: Ved afslutningen af denne periode skal produktet anvendes eller kasseres.
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 forekomme, hvis præparatet anvendes gentagne gange eller anvendes til patienter, der er overfølsomme over for bestanddele i produktet.
English: All pack sizes may not be marketed in all countries
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført i alle lande.
English: Common Common Common
Danish: Almindelig Almindelig Almindelig Almindelig
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 forplantning, embryoets eller fostrets udvikling, svangerskabets forløb samt peri- og postnatale udvikling.
English: Before administration of EVICEL, care is to be taken that parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Danish: Før EVICEL påføres, skal det sikres, at områder af kroppen udenfor det ønskede applikationsområde er tilstrækkeligt beskyttet (dækket) til at forhindre vævsadhæsion på uønskede steder.
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 medicin bliver fremstillet af blod eller plasma fra mennesker, tages der visse forholdsregler for at forhindre, at patienterne får overført infektioner.
English: The events were evenly distributed across treatment arms, with 8 each in the EVICEL and the control groups.
Danish: Hændelserne var jævnt fordelt på behandlingsgrupperne med 8 i både EVICEL-gruppen og kontrolgrupperne.
English: Neurotoxicity studies performed with EVICEL confirmed that subdural administration in the rabbit was not associated with any evidence of neurotoxicity.
Danish: Neurotoksicitetsstudier udført med EVICEL har bekræftet, at subdural administration til kaniner ikke var forbundet med tegn på neurotoksicitet.
English: 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: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Danish: Forholdsreglerne kan være af begrænset værdi mod ikke-kappeklædte virus som parvovirus B19.
English: The use of EVICEL in patients undergoing radiotherapy within 7 days after surgery has not been evaluated.
Danish: Anvendelse af EVICEL hos patienter, der gennemgår strålebehandling inden for 7 dage efter operation, er ikke blevet evalueret.
English: Do not use EVICEL
Danish: Brug ikke EVICEL
English: This also applies to any unknown or emerging viruses, or other types of infections.
Danish: Dette gælder også eventuelle ukendte eller nyopdagede virus eller andre typer infektioner.
English: No adverse reactions were reported during the study.
Danish: Ingen bivirkninger blev rapporteret under studiet.
English: There is not enough information available to know whether any particular risks are associated with the use of EVICEL during pregnancy or whilst breast-feeding.
Danish: Der foreligger ikke tilstrækkelig information til at vide, om der er eventuelle særlige risici forbundet med brugen af EVICEL under graviditet eller amning.
English: There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.
Danish: Der er også en teoretisk risiko for, at du kan udvikle antistoffer mod proteinerne i EVICEL, hvilket kan påvirke den måde, blodet størkner på.
English: • The educational package should contain: o The Summary of Product Characteristics o The section titled “The following information is intended for medical or healthcare professionals only” of the latest package leaflet.
Danish: • Informationspakken skal indeholde: o Produktresuméet o Afsnittet med titlen ”Nedenstående oplysninger er kun beregnet til læger og sundhedspersonale” i den seneste indlægsseddel o Undervisningsmateriale til sundhedspersonale
English: Keeping the tip of the applicator as close to the tissue surface as possible, but without touching the tissue during application, apply individual drops to the area to be treated.
Danish: Idet applikatorspidsen holdes så tæt som muligt på vævsoverfladen, men uden at berøre vævet under påføringen, påføres enkeltdråber på det område, der skal behandles.
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: Ligesom det er tilfældet med sammenlignelige produkter eller trombinopløsninger, kan produktet blive denatureret efter udsættelse for opløsninger, der indeholder alkohol, jod eller tungmetaller (f.eks. antiseptiske opløsninger).
English: The accessory tips should only be used by persons adequately trained in laparoscopic, laparoscopic-assisted, or open surgical procedures.
Danish: De tilhørende spidser bør kun anvendes af personer med fornøden uddannelse i laparoskopiske, laparoskopisk assisterede eller åbne kirurgiske procedurer.
English: Human clottable protein containing mainly fibrinogen and fibronectin *
Danish: Humant koagulerbart protein indeholdende hovedsageligt fibrinogen og fibronektin *
English: If the applicator tip becomes blocked, the catheter tip can be cut back in 0.5 cm increments.
Danish: Hvis applikatorspidsen tilstoppes, kan kateterspidsen skæres tilbage med 0,5 cm ad gangen.
English: Fibrinogen is a concentrate of clottable protein and thrombin is an enzyme that causes clottable protein to coalesce.
Danish: Fibrinogen er et koncentrat af koagulerbart protein og trombin er et enzym der får koagulerbart protein til at størkne.
English: The approved shelf life of EVICEL is 2 years storage at ≤ -18
Danish: Den godkendte opbevaringstid for EVICEL er 2 år ved temperaturer ≤ -18
English: The incidence of CSF leakage and the incidence of Surgical Site Infections were monitored as safety endpoints in the study.
Danish: Incidensen af CSF-lækage og incidensen af infektioner på operationsstedet (SSI) blev overvåget som endepunkter i sikkerhedsstudier.
English: * Total quantity of protein is 80 - 120 mg/ml
Danish: * Den samlede mængde protein er 80-120 mg/ml
English: The fibrinogen and thrombin components are stable at room temperature for up to 24 hours but when they have been drawn up into the administration device, they must be used immediately.
Danish: Fibrinogen- og trombinkomponenterne er stabile ved stuetemperatur i op til 24 timer, men når de er opsuget i påføringsanordningen, skal de anvendes straks.
English: As a consequence, intravascular pharmacokinetic studies were not performed in man.
Danish: Som følge heraf er der ikke foretaget intravaskulære farmakokinetiske forsøg med mennesker.
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 viruses/infections.
Danish: Disse omfatter omhyggelig udvælgelse af blod- og plasmadonorer for at sikre, at personer med risiko for at have infektioner udelukkes, samt test af alle donationer og plasmareserver for tegn på virus/infektioner.
English: The amount of EVICEL that will be applied depends on the surface area of tissue to be treated during the operation.
Danish: Den mængde EVICEL, som påføres, afhænger af den vævsoverflade, der skal behandles under operationen.
English: No toxicological effects due to the solvent detergent reagents (TnBP and Triton X-100) used in the virus inactivation procedure are expected since the residual levels are less than 5 µg/ml.
Danish: Der forventes ingen toksikologisk effekt som følge af de opløsningsmiddel-/rensemiddelreagenser (TnBP og Triton X-100), der anvendes i virusinaktiveringsprocessen, eftersom restniveauerne er mindre end 5 µg/ml.
English: It is dripped or sprayed onto cut tissue where it forms a thin layer that seals the tissue and/or stops bleeding.
Danish: Det dryppes eller sprayes på snitfladen af væv, hvor det danner et tyndt lag, der forsegler vævet og/eller stopper blødningen.
English: Application of the product must be individualised by the treating physician.
Danish: Applikationen af produktet tilpasses individuelt af den behandlende læge.
English: • Nearby areas should be protected to make sure that EVICEL is only applied onto the surface which is to be treated.
Danish: • De omgivende områder skal beskyttes for at sikre, at der kun påføres EVICEL på den overflade, der skal behandles.
English: If you get any side effects, talk to your doctor , pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, apotekspersonalet eller sygeplejersken.
English: The MAH shall ensure that in each Member State where Evicel is marketed, all healthcare professionals who are using Evicel are provided with an educational package aiming at increasing awareness about the risk of life-threatening gas embolism if the product is sprayed incorrectly and providing guidance on how to manage that risk:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale, som anvender Evicel, i enhver medlemsstat, hvor Evicel markedsføres, forsynes med en informationspakke, der har til formål at øge opmærksomheden omkring risikoen for livstruende gasemboli, hvis produktet sprayes forkert, og der giver vejledning om håndtering af denne risiko:
English: 50 - 90 mg 100 - 180 mg 250 - 450 mg
Danish: 100-180 mg 250-450 mg
English: • controlling bleeding in the stomach or intestines by applying the product through an endoscope (tube)
Danish: • til kontrol af blødninger i maven eller tarmene, hvor produktet anvendes ved hjælp af endoskopi (rør)
English: If application of a single layer of EVICEL does not completely stop the bleeding, a second layer may be applied.
Danish: Hvis et enkelt lag EVICEL ikke stopper blødningen helt, kan der påføres et lag mere.