FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical studies demonstrating haemostasis and suture support were conducted in a total of 147 patients (75 with EVICEL, 72 with control) undergoing vascular surgery with PTFE grafts and in a total of 135 patients (66 with EVICEL, 69 with control) undergoing retroperitoneal and intra-abdominal surgery.
Slovenian: Klinične študije hemostaze in podpore šivom so opravili pri 147 bolnikih (75 jih je prejelo zdravilo EVICEL, 72 jih je bilo vključenih v kontrolno skupino) po žilnih kirurških posegih s presadki iz PTFE in pri 135 bolnikih (66 jih je prejelo zdravilo EVICEL, 69 jih je bilo vključenih v kontrolno skupino) po retroperitonealnih oz. intraabdominalnih kirurških posegih.
English: Store in a freezer at -18°C or colder.
Slovenian: Shranjujte v zamrzovalniku pri temperaturi do -18 °C.
English: Disposal
Slovenian: Odtaljevanje
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.
Slovenian: Sočasna uporaba zdravila EVICEL za lepljenje duralnih šivov s presadki iz umetnih materialov ali duralnimi presadki v kliničnih študijah ni bila ovrednotena.
English: Plasma Fractionation Institute (Omrix-PFI) MDA Blood Bank
Slovenian: Humani fibrinogen in humani trombin: Omrix Biopharmaceuticals Ltd. Plasma Fractionation Institute (Omrix-PFI) MDA Blood Bank
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g., sickle cell disease or haemolytic anaemia).
Slovenian: Okužba s parvovirusom B19 je lahko resna pri nosečnicah (okužba ploda) in posameznikih z oslabljenim delovanjem imunskega sistema ali tistih, ki imajo določene vrste anemij (npr. srpastocelično anemijo ali hemolitično anemijo).
English: Most serious side effects - Watery fluid coming out of your wound or nose (CSF leakage/CSF rhinorrhea) - Headache, nausea, and vomiting (due to Subdural Hygroma, which is accumulation of CSF in the subdural space) - Fever, or prolonged constipation, flatulence (due to abdominal abscess)
Slovenian: Najresnejši neželeni učinki - vodi podobna tekočina, ki izteka iz rane ali nosu (uhajanje likvorja/likvorska rinoreja), - glavobol, slabost in bruhanje (zaradi subduralnega higroma, kar pomeni kopičenje likvorja v subduralnem prostoru), - zvišana telesna temperatura ali dalj časa trajajoče zaprtje, vetrovi (zaradi abdominalnega abscesa).
English: After thawing, store unopened vials in the outer carton at 2°C -8°C for up to 30 days starting on:
Slovenian: Po odtalitvi shranjujte neodprte viale v zunanji škatli pri 2 °C-8 °C do 30 dni po:
English: Store in the outer carton at -18°C or colder, to protect from light.
Slovenian: Shranjujte pri temperaturi do -18 °C v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: It must not be applied intravascularly.
Slovenian: Ne sme se ga uporabljati intravaskularno.
English: If these symptoms occur, the administration has to be discontinued immediately.
Slovenian: Če se pojavijo ti simptomi, morate uporabo nemudoma prekiniti.
English: The solutions should be clear or slightly opalescent.
Slovenian: Raztopini morata biti bistri ali rahlo motni.
English: Once drawn up into the application device, they must be used immediately.
Slovenian: Po vnosu sestavin v aplikator ju morate nemudoma porabiti.
English: • sealing in transphenoidal and otoneurosurgical procedures
Slovenian: • lepljenju pri transfenoidnih in otonevrokirurških posegih.
English: As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Slovenian: V nadaljnjem procesu celjenja rane plazmin inducira povečano fibrinolitično aktivnost in razgradnjo fibrina v fibrinske produkte.
English: Incision site haemorrhage Vascular graft occlusion Wound
Slovenian: Okluzija žilnega presadka Rana
English: Do not use after the expiry date stated on the carton and label.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki.
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.
Slovenian: • Zdravilo EVICEL se ne sme uporabljati za lepljenje šiva v duri, če so po šivanju odprtine, večje od 2 mm.
English: 35 cm rigid tip 45 cm flexible tip
Slovenian: Togi nastavek dolžine 35 cm Prožni nastavek dolžine 45 cm
English: Adverse reaction rates in retroperitoneal or intra-abdominal surgery study
Slovenian: Stopnje neželenih učinkov v študiji uporabe pri retroperitonealnih ali intraabdominalnih kirurških posegih
English: In a controlled study involving 139 patients undergoing elective neurosurgical procedures (89 treated with EVICEL and 50 controls), a total of 7 subjects treated with EVICEL experienced nine AEs that were considered to be possibly related to the study product.
Slovenian: V nadzorovani študiji elektivnih nevrokirurških posegov pri 139 bolnikih (89 zdravljenih z zdravilom EVICEL, 50 v kontrolni skupini) je 7 preiskovancev, zdravljenih z zdravilom EVICEL, doživelo devet neželenih učinkov, ki so bili morda povezani s preiskovanim zdravilom.
English: The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer.
Slovenian: Zdravilo nato pršite na površino tkiva v kratkih razprških (0,1-0,2 ml), da nastane tanek, enakomeren sloj.
English: The measures taken in the manufacture of fibrinogen and thrombin are considered effective for lipid coated viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and the non-enveloped virus, hepatitis A. The measures taken may be of limited value against parvovirus B19.
Slovenian: Ukrepi, ki se izvajajo pri izdelavi raztopin fibrinogena in trombina, se štejejo za učinkovite proti virusom z lipidno ovojnico, kot so humani virus imunske pomanjkljivosti (HIV), virus hepatitisa B in virus hepatitisa C, ter proti virusu hepatitisa A, ki je brez ovojnice.
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.
Slovenian: - oznake za regulatorje tlaka, ki navajajo ustrezni tlak in razdaljo od tkiva pri odprtih in laparoskopskih posegih; - opozorilno kartico z navedbo ustreznega tlaka in razdaljo od tkiva za uporabo pršilnika pri odprtih in laparoskopskih posegih; - oznako za namestitev na zračno cev naprave, kjer so navedena navodila za uporabo.
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.
Slovenian: Zdravila EVICEL ne smete uporabiti za lepljenje šiva v duri, če so po šivanju odprtine, večje od 2 mm.
English: EVICEL is supplied as a package containing two separate vials (glass type I) with rubber stoppers (type I), each containing 1 ml, 2 ml, or 5 ml solution of Human Fibrinogen and Human Thrombin, respectively.
Slovenian: Zdravilo EVICEL je na voljo v pakiranju z dvema vialama (steklo tipa I) z gumijastimi zamaški (tipa I), ki vsebujeta 1 ml, 2 ml ali 5 ml raztopine humanega fibrinogena oz. humanega trombina.
English: 1 ml vial
Slovenian: 1 ml viala
English: Adverse reactions - neurosurgery
Slovenian: Neželeni učinki - nevrokirurški posegi
English: • EVICEL must not be used as a sealant when the dura mater cannot be sutured.
Slovenian: • Zdravilo EVICEL se ne sme uporabljati kot lepilo, kadar dure ni mogoče šivati.
English: Life-threatening air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer EVICEL.
Slovenian: Opisani so pojavi zračne ali plinske embolije ob uporabi pršilnikov z regulatorjem tlaka za uporabo zdravila EVICEL.
English: Among 135 patients undergoing retroperitoneal and intra-abdominal surgery (67 patients treated with EVICEL and 68 controls), no adverse events were considered to be causally related to the study treatment according to the investigator assessments.
Slovenian: Pri 135 bolnikih (67 bolnikov, zdravljenih z zdravilom EVICEL, 68 bolnikov v kontrolni skupini) po retroperitonealnem ali intraabdominalnem kirurškem posegu po mnenju raziskovalcev noben izmed neželenih učinkov ni bil vzročno povezan s preučevanim zdravilom.
English: How to use EVICEL
Slovenian: Kako uporabljati zdravilo EVICEL
English: Once drawn up into the application device, the product must be used immediately.
Slovenian: Po vnosu sestavin v aplikator morate zdravilo nemudoma porabiti.
English: In a controlled study involving 147 patients undergoing vascular grafting procedures (75 treated with EVICEL and 72 controls), a total of 16 subjects were reported to have had a graft thrombosis/occlusion adverse event during the study period.
Slovenian: V nadzorovani študiji žilnih presaditev pri 147 bolnikih (75 zdravljenih z zdravilom EVICEL, 72 v kontrolni skupini) so pri 16 preiskovancih med trajanjem študije ugotovili neželen dogodek tromboze/okluzije presadka.
English: • Prior to applying EVICEL, the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Slovenian: • Pred nanosom zdravila EVICEL je treba površino rane osušiti s standardnimi tehnikami (npr. z večkratno aplikacijo kompres, blazinic, z uporabo sesalnih pripomočkov).
English: 2 ml vial
Slovenian: 2 ml viala
English: Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and anaphylaxis.
Slovenian: Znaki takih reakciji vključujejo koprivnico, izpuščaj, stiskanje v prsih, sopenje, padec krvnega tlaka in anafilaksijo.
English: EVICEL is intended for epilesional use only.
Slovenian: Zdravilo EVICEL je namenjeno samo za epilezijsko uporabo.
English: EVICEL can be used in blood vessel surgery and in surgery taking place on the posterior abdominal wall.
Slovenian: Zdravilo EVICEL se lahko uporabi pri kirurških posegih na ožilju in kirurških posegih na zadnji trebušni steni.
English: Intracranial hypotension (CSF leakage)
Slovenian: Intrakranialna hipotenzija (uhajanje likvorja) Likvorska rinoreja Glavobol
English: Calcium ions are required for both, the conversion of fibrinogen and the crosslinking of fibrin.
Slovenian: Za obe reakciji, pretvorbo fibrinogena v fibrin in navzkrižno povezovanje fibrina, so potrebni kalcijevi ioni.
English: EVICEL is available in the following pack sizes: 2 x 1 ml, 2 x 2 ml, and 2 x 5 ml.
Slovenian: Zdravilo EVICEL je na voljo v pakiranjih naslednjih velikosti: 2 x 1 ml, 2 x 2 ml in 2 x 5 ml. Na trgu posameznih držav morda ni vseh navedenih pakiranj.
English: EVICEL solutions for sealant human fibrinogen, human thrombin
Slovenian: EVICEL raztopini za lepilo humani fibrinogen, humani trombin
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.
Slovenian: V redkih primerih so pri bolnikih, zdravljenih s fibrinskimi lepili/hemostatiki, možne preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč in zbadajoč občutek na mestu uporabe, bronhospazem, mrazenje, zardevanje, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, slabost, nemir, tahikardijo, stiskanje v prsih, mravljinčenje, bruhanje, sopenje).
English: Prior to applying EVICEL the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Slovenian: Pred nanosom zdravila EVICEL je treba površino rane osušiti s standardnimi tehnikami (npr. z večkratno aplikacijo kompres, blazinic, z uporabo sesalnih pripomočkov).
English: EVICEL should only be applied using the CE-marked EVICEL application device and optional use of a tip accessory to the device.
Slovenian: Zdravilo EVICEL se sme nanašati samo z aplikatorjem EVICEL, ki ima oznako CE, in z izbirno uporabo nastavkov na aplikatorju.
English: Within the 2 years shelf life, after thawing, unopened vials can be stored at 2C - 8C and protected from light, for up to 30 days.
Slovenian: V obdobju 2 let roka uporabnosti lahko odtaljene, neodprte viale, ki smo jih zaščitili pred svetlobo, pri temperaturi 2-8 C shranjujemo do 30 dni.
English: • EVICEL must not be used as a glue for the fixation of dural patches.
Slovenian: • Zdravilo EVICEL se ne sme uporabljati kot lepilo za pritrjanje duralnih presadkov.
English: Evicel is for epilesional use.
Slovenian: Zdravilo EVICEL je namenjeno za epilezijsko uporabo.
English: Do not use this medicine after the expiry date which is stated on the label as well as on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Adverse reactions in retroperitoneal or intra-abdominal surgery study Infections and infestations
Slovenian: Neželeni učinki v študiji uporabe pri retroperitonealnih ali intraabdominalnih kirurških posegih Infekcijske in parazitske bolezni Abdominalen absces
English: 800 - 1,200 IU 1,600 - 2,400 IU 4,000 - 6,000 IU
Slovenian: 1600-2400 i.e.
English: Component 1: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, and water for injections.
Slovenian: Raztopina 1: argininijev klorid, glicin, natrijev klorid, natrijev citrat, kalcijev klorid in voda za injekcije.
English: Human Fibrinogen: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, water for injections.
Slovenian: Humani fibrinogen: argininijev klorid, glicin, natrijev klorid, natrijev citrat, kalcijev klorid, voda za injekcije
English: Human Thrombin: calcium chloride, human albumin, mannitol, sodium acetate, water for injections.
Slovenian: Humani trombin: kalcijev klorid, humani albumin, manitol, natrijev acetat, voda za injekcije
English: EVICEL is a fibrin sealant.
Slovenian: Zdravilo EVICEL je fibrinsko lepilo.
English: What EVICEL contains
Slovenian: Kaj vsebuje zdravilo EVICEL
English: EVICEL solutions for sealant human fibrinogen human thrombin
Slovenian: EVICEL raztopini za lepilo humani fibrinogen humani trombin
English: When spraying EVICEL, changes in blood pressure, pulse, oxygen saturation, and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.
Slovenian: Med pršenjem zdravila EVICEL je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava zračne ali plinske embolije.
English: Component 2: calcium chloride, human albumin, mannitol, sodium acetate, and water for injections.
Slovenian: Raztopina 2: kalcijev klorid, humani albumin, manitol, natrijev acetat in voda za injekcije.
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Znaki preobčutljivostnih reakcij so med drugim koprivnica, generalizirana urtikarija, stiskanje v prsih, sopenje, hipotenzija in anafilaksija.
English: EVICEL solutions for sealant
Slovenian: EVICEL raztopini za lepilo
English: EVICEL solutions for sealant human fibrinogen:
Slovenian: EVICEL raztopini za lepilo humani fibrinogen:
English: Tabulated list of adverse reactions
Slovenian: Tabelarni prikaz neželenih učinkov
English: EVICEL must not be used as a glue for the fixation of dural patches.
Slovenian: Zdravila EVICEL ne smete uporabiti kot lepilo za pritrjanje duralnih presadkov.
English: Leaflets giving detailed instructions for use of EVICEL in conjunction with the application device and optional accessory tips are provided with the package of the application device and of the accessory tips.
Slovenian: Aplikatorju in nastavkom so priložena navodila za uporabo zdravila EVICEL z aplikatorjem in izbirnimi nastavki.
English: When spraying EVICEL, changes in blood pressure, pulse, oxygen saturation and end tidal CO2 should be monitored because of the possibility of occurrence of gas embolism.
Slovenian: Med pršenjem zdravila EVICEL je treba spremljati spremembe krvnega tlaka, srčnega utripa, nasičenosti s kisikom in izdihanega CO2 zaradi možnosti pojava plinske embolije.
English: 15 - 20 psi (1.0 - 1.4 bar)
Slovenian: 15-20 psi bara)
English: Spray pressure
Slovenian: Tlak pršenja
English: • EVICEL must not be applied intravascularly.
Slovenian: • Zdravila EVICEL se ne sme dajati intravaskularno.
English: 1 vial containing 5 ml of human clottable protein 1 vial containing 5 ml of human thrombin
Slovenian: 1 viala vsebuje 5 ml humane koagulacijske beljakovine 1 viala vsebuje 5 ml humanega trombina
English: 35 cm rigid tip
Slovenian: Togi nastavek dolžine 35 cm
English: EVICEL must not be used as a sealant when the dura mater cannot be sutured.
Slovenian: Zdravila EVICEL ne smete uporabiti kot lepilo, če dure ni mogoče šivati.
English: - Numbness or pain in your extremities, change in skin colour (due to Graft Occlusion or Thrombosis) The frequency of this effect was uncommon (may affect up to 1 in 100 people).
Slovenian: - Odrevenelost ali bolečine v okončinah, spremenjena barva kože (zaradi okluzije ali tromboze presadka).
English: oC. Do not use after the expiry date stated on the carton.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
English: 1 vial containing 2 ml human clottable protein 1 vial containing 2 ml of human thrombin
Slovenian: 1 viala vsebuje 2 ml humane koagulacijske beljakovine 1 viala vsebuje 2 ml humanega trombina
English: Adverse reactions - vascular surgery
Slovenian: Neželeni učinki - žilni kirurški posegi
English: Application of the product must be individualised by the treating physician.
Slovenian: Nanos zdravila določi lečeči zdravnik za vsakega bolnika posamezno.
English: EVICEL Applicator Device
Slovenian: Aplikator EVICEL
English: 1 vial containing 1 ml of human clottable protein 1 vial containing 1 ml of human thrombin
Slovenian: 1 viala vsebuje 1 ml humane koagulacijske beljakovine 1 viala vsebuje 1 ml humanega trombina
English: 20 - 25 psi (1.4 - 1.7 bar)
Slovenian: 20-25 psi bara)
English: o requirement to dry the wound using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) prior to using the product o requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2 when spraying the product, for the occurrence of gas embolism.
Slovenian: - pri laparoskopskih postopkih je najmanjša razdalja 4 cm, če je mogoče razdaljo pršenja natančno presoditi ; o ustreznem tlaku in razdalji od tkiva, ki sta odvisna od vrste kirurškega posega (odprt ali laparoskopski); o tem, da je treba površino rane osušiti s standardnimi tehnikami (npr. z večkratno aplikacijo kompres, blazinic, z uporabo sesalnih pripomočkov) pred uporabo zdravila; o tem, da je treba med pršenjem zdravila skrbno spremljati krvni tlak, srčni utrip, nasičenost s kisikom in izdihan CO2 zaradi možnosti pojava plinske embolije; o tem, kateri(-e) regulator(-je) je treba uporabiti, skladno s priporočili proizvajalca in navodili za uporabo, ki so navedeni v Povzetku glavnih značilnosti zdravila.
English: Do not re-freeze once thawed.
Slovenian: Odtaljenega zdravila ne zamrzujte ponovno.
English: Life-threatening thromboembolic complications may occur if the product is unintentionally applied intravascularly.
Slovenian: Če zdravilo nenamerno uporabite intravaskularno, lahko pride do življenjsko nevarnega tromboemboličnega zapleta.
English: To avoid the risk of potentially life-threatening air or gas embolism EVICEL should be sprayed using pressurized CO2 gas only (see table below).
Slovenian: Da bi se izognili tveganju za nastanek smrtno nevarne zračne ali plinske embolije, morate zdravilo EVICEL pršiti samo s plinom CO2 pod tlakom (glejte spodnjo tabelo).
English: Adverse reactions in neurosurgery study Infections and infestations
Slovenian: Neželeni učinki v študiji uporabe pri nevrokirurških posegih Infekcijske in parazitske bolezni Meningitis
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded.
Slovenian: Kljub temu pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni možno povsem izključiti možnosti prenosa povzročiteljev nalezljivih bolezni, tudi tistih, ki do danes še niso poznani, porajajočih se virusov ali drugih vrst okužb.
English: How to store EVICEL
Slovenian: Shranjevanje zdravila EVICEL
English: EVICEL solutions for sealant human thrombin:
Slovenian: EVICEL raztopini za lepilo humani trombin:
English: Adverse reactions in vascular surgery study Infections and infestations
Slovenian: Neželeni učinki v študiji uporabe pri žilnih kirurških posegih Infekcijske in parazitske bolezni Okužba presadka, stafilokokna okužba
English: 20 psi (1.4 bar)
Slovenian: Prožni nastavek dolžine 45 cm20 psi (1,4 bara)
English: Human thrombin vial Calcium chloride Human albumin Mannitol
Slovenian: Viala s humanim trombinom kalcijev klorid humani albumin manitol natrijev acetat voda za injekcije
English: Complete haemostasis should be achieved before application of EVICEL to seal the dural suture line.
Slovenian: Pred nanosom zdravila EVICEL za lepljenje duralnih šivov je treba doseči popolno hemostazo.
English: Spray application of EVICEL should not be used in endoscopic procedures.
Slovenian: Zdravila EVICEL pri endoskopskih posegih ne smete nanašati s pršenjem.
English: EVICEL must not be applied intravascularly.
Slovenian: Zdravila EVICEL ne smete uporabiti intravaskularno.
English: • To avoid the risk of potentially fatal air or gas embolism EVICEL should be sprayed using pressurised CO2 gas only.
Slovenian: • Da bi se izognili tveganju za potencialno življenjsko nevarno zračno ali plinsko embolijo, se sme zdravilo EVICEL pršiti samo s plinom CO2 pod tlakom.
English: Component 1: 1 vial containing 5 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 5 ml of human thrombin (800 - 1200 IU/ml).
Slovenian: Raztopina 1: 1 viala vsebuje 5 ml humane koagulacijske beljakovine (50-90 mg/ml) Raztopina 2: 1 viala vsebuje 5 ml humanega trombina (800-1200 i.e./ml)
English: Solutions for sealant
Slovenian: Raztopini za lepilo
English: Component 1: 1 vial containing 1 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 1 ml of human thrombin (800 - 1200 IU/ml).
Slovenian: Raztopina 1: 1 viala vsebuje 1 ml humane koagulacijske beljakovine (50-90 mg/ml) Raztopina 2: 1 viala vsebuje 1 ml humanega trombina (800-1200 i.e./ml)
English: EVICEL forms a clear film over the area of application.
Slovenian: Zdravilo EVICEL po področju nanosa napravi prozoren film.
English: * Total quantity of protein is 80 - 120 mg/ml
Slovenian: * Skupna količina beljakovin je 80-120 mg/ml Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Component 1: Human clottable protein containing mainly fibrinogen and fibronectin (50 - 90 mg/ml) Component 2: Human thrombin (800 - 1,200 IU/ml)
Slovenian: Raztopina 1: humana koagulacijska beljakovina, ki vsebuje predvsem fibrinogen in fibronektin (5090 mg/ml)
English: Component 1: 1 vial containing 2 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 2 ml of human thrombin (800 - 1200 IU/ml).
Slovenian: Raztopina 1: 1 viala vsebuje 2 ml humane koagulacijske beljakovine (50-90 mg/ml) Raztopina 2: 1 viala vsebuje 2 ml humanega trombina (800-1200 i.e./ml)