FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Zdravilo EVICEL se lahko uporabi tudi za podporo neprepustnemu zapiranju možganskih ovojnic (dure) med nevrokirurškim posegom, kadar druge kirurške tehnike niso dovolj.
English: EVICEL is indicated in adults as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis (see section 5.1).
Slovenian: Zdravilo EVICEL je indicirano kot podporno zdravljenje za izboljšanje hemostaze pri kirurških posegih, kjer standardne kirurške tehnike ne zadoščajo (glejte poglavje 5.1).
English: • controlling bleeding in the stomach or intestines by applying the product through an endoscope (tube)
Slovenian: • nadzoru krvavitev v želodcu ali črevesju z apliciranjem prek endoskopa (cevke),
English: • surgery to the brain or spinal cord except for support of watertight closure of cerebral envelopes (dura mater)
Slovenian: • kirurških posegih na možganih ali hrbtenjači, razen za podporo neprepustnemu zapiranju možganskih ovojnic (dure),
English: 4 - 10 cm (1.6 - 4 in)
Slovenian: 4-10 cm (1,6-4 palce)
English: Component 2 Human thrombin
Slovenian: Raztopina 2 humani trombin
English: This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface.
Slovenian: Zdi se, da je ta pojav povezan z uporabo pršilnika s tlaki, ki so višji od priporočenega, in/ali z uporabo v neposredni bližini tkivne površine.
English: The product should only be administered according to the instructions and with the devices recommended for this product (see section 6.6).
Slovenian: Zdravilo se sme nanašati po navodilih in s pripomočki, priporočenimi za to zdravilo (glejte poglavje 6.6).
English: The incidence of CSF leakage and the incidence of Surgical Site Infections were monitored as safety endpoints in the study.
Slovenian: Pojavnost uhajanja likvorja in pojavnost okužb kirurškega mesta so v študiji spremljali kot varnostna opazovana dogodka.
English: The frequency of the effects listed above was common (may affect up to 1 in 10 people).
Slovenian: Zgoraj navedeni neželeni učinki so bili pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov).
English: Other medicines and EVICEL
Slovenian: Druga zdravila in zdravilo EVICEL
English: Human clottable protein containing mainly fibrinogen and fibronectin *
Slovenian: Raztopina 1 humana koagulacijska beljakovina, ki vsebuje predvsem fibrinogen in fibronektin*
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.
Slovenian: Študije določanja mutagenosti na bakterijah so bile negativne za sam trombin, biološko aktivno sestavino (vsebuje fibrinogen, citrat, glicin, traneksamsko kislino in argininijev klorid), sam TnBP in sam Triton X-100 pri uporabljenih koncentracijah.
English: Do not re-freeze.
Slovenian: Ne zamrzujte ponovno.
English: • EVICEL should not be used in endoscopic surgery.
Slovenian: • Zdravila EVICEL se ne sme uporabljati pri endoskopskih kirurških posegih.
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.
Slovenian: Opravljene so bile študije na kuncih, da bi ovrednotili absorpcijo in eliminacijo trombina po nanosu na rezano površino jeter po delni hepatektomiji.
English: Neurotoxicity studies performed with EVICEL confirmed that subdural administration in the rabbit was not associated with any evidence of neurotoxicity.
Slovenian: Študije nevrotoksičnosti zdravila EVICEL so potrdile, da subduralna uporaba pri kuncih ni povezana z dokazi nevrotoksičnosti.
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.
Slovenian: Uporabljeni odmerek je odvisen od spremenljivk, ki so med drugim vrsta kirurškega posega, velikost področja, način nameravane aplikacije in število nanosov.
English: EVICEL spray application should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy.
Slovenian: Zdravilo EVICEL se s pršenjem lahko nanaša le, kadar je mogoče natančno presoditi razdaljo od pršilnika, zlasti med laparoskopijo.
English: Inadvertent intravascular injection could lead to thromboembolic event and disseminated intravascular coagulation (DIC), and there is also a risk of anaphylactic reaction (see section 4.4).
Slovenian: Nenamerno intravaskularno injiciranje lahko povzroči tromboembolični dogodek in diseminirano intravaskularno koagulacijo, prav tako pa obstaja tveganje za anafilaktično reakcijo (glejte poglavje
English: • gluing tissues together
Slovenian: • lepljenju tkiv skupaj,
English: Draw the contents of the two vials into the application device, following the instructions for use in the device package.
Slovenian: Posesajte vsebino obeh vial v aplikator po navodilih, ki so priložena aplikatorju.
English: EVICEL must not be injected into tissue or blood vessels because it would cause clots which could be fatal.
Slovenian: Zdravila EVICEL se ne sme injicirati v tkivo ali žile, ker lahko povzroči tvorbo strdkov, ki lahko povzročijo smrt.
English: Omrix Biopharmaceuticals N.V. Leonardo Da Vinci Laan 15 B-1831 Diegem
Slovenian: Leonardo Da Vinci Laan 15 B-1831 Diegem
English: Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Slovenian: Če je strdek predebel, lahko to negativno vpliva na učinkovitost zdravila in na proces celjenja rane.
English: Safety monitoring focused on the specific adverse reactions of graft patency, thrombotic events, and bleeding events.
Slovenian: Varnostno spremljanje se je osredotočilo na specifične neželene učinke, kot so prehodnost presadka, trombotični dogodki in krvavitve.
English: 5 How to store EVICEL Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila EVICEL Vsebina pakiranja in dodatne informacije
English: If you get any side effects, talk to your doctor , pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: EVICEL is applied in adults during surgical operations to reduce bleeding and oozing during and after the operation.
Slovenian: Zdravilo EVICEL se uporablja pri odraslih med kirurškimi posegi za zmanjšanje krvavitev in izcejanja med posegom in po njem.
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).
Slovenian: Tako kot podobna zdravila ali raztopine trombina lahko zdravilo EVICEL denaturirajo raztopine z alkoholom, jodom ali težkimi kovinami (npr. antiseptiki).
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.
Slovenian: • Uporaba zdravila EVICEL pri nevrokirurškem posegu pri bolnikih, ki se zdravijo tudi s presadki ali duralnimi presadki, v kliničnih študijah ni bila preučena.
English: • When EVICEL is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue.
Slovenian: • Ko kirurg uporabi zdravilo EVICEL med kirurškim posegom, mora paziti, da ga nanese samo na površino tkiva.
English: Laparoscopic procedures
Slovenian: Laparoskopski posegi
English: Spray distance from tissue and CO2 pressure should be within the ranges recommended by the manufacturer (see table in section 6.6 for pressure and distance).
Slovenian: Razdalja med pršilnikom in tkivom ter tlak CO2 morata biti v razponih, ki jih priporoča izdelovalec (za tlak in razdaljo glejte tabelo v poglavju 6.6) .
English: The active ingredients are as follows:
Slovenian: Učinkovine so naslednje:
English: Before use, the product must reach 20-30°C.
Slovenian: Temperatura zdravila pred uporabo mora biti med 20 in 30 °C.
English: If these symptoms occur, the administration should be discontinued immediately.
Slovenian: Če se pojavijo ti simptomi, je treba uporabo nemudoma prekiniti.
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.
Slovenian: Če nastavek aplikatorja karseda približate površini tkiva, vendar se tkiva med nanašanjem ne dotikate, lahko na želena področja nanašate posamezne kapljice zdravila.
English: The use of EVICEL as a sealant in transphenoidal and otoneurosurgical procedures has not been studied.
Slovenian: Uporaba zdravila EVICEL kot lepila pri transfenoidnih in otonevrokirurških posegih ni bila preučena.
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.
Slovenian: Izmed 135 bolnikov po retroperitonealnem oz. intraabdominalnem kirurškem posegu, ki so bili vključeni v nadzorovano študijo zdravila EVICEL, so bili 4 bolniki, zdravljeni z zdravilom EVICEL, stari 16 let ali manj.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede priprave zdravila pred nanosom glejte poglavje 6.6.
English: After thawing, unopened vials can be stored at 2°C-8°C and protected from light, for up to 30 days, without being frozen again during this period.
Slovenian: Po odtalitvi lahko neodprte viale shranjujete pri 2 °C-8 °C in zaščitene pred svetlobo do 30 dni, vendar jih v tem času ne smete ponovno zamrzniti.
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.
Slovenian: Ker pa se zdravilo EVICEL uporablja med kirurškim posegom, se o splošnem tveganju posega med nosečnostjo oz. dojenjem posvetujte z zdravnikom.
English: What EVICEL is and what it is used for What you need to know before you use EVICEL How to use EVICEL
Slovenian: Kaj je zdravilo EVICEL in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo EVICEL Kako uporabljati zdravilo EVICEL Možni neželeni učinki
English: • It is not known whether radiation therapy could affect the effectiveness of fibrin sealant when used for suture line sealing during neurosurgery.
Slovenian: • Ni znano, ali zdravljenje s sevanjem vpliva na učinkovitost fibrinskega lepila, kadar se ta uporablja za lepljenje šivov pri nevrokirurškem posegu.
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.
Slovenian: Na škatlo morate zapisati nov datum izteka roka uporabnosti pri 2 °C-8 °C, vendar ta novi datum ne sme presegati datuma izteka roka uporabnosti, ki ga je izdelovalec natisnil na škatlo in nalepko.
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.
Slovenian: Zelo priporočljivo je, da ob vsaki uporabi zdravila EVICEL zabeležite ime in serijsko številko zdravila, da se vzdržuje sledljivost med bolnikom in serijo zdravila.
English: For safety with respect to transmissible agents, see section 4.4.
Slovenian: Varnost pred prenosljivimi povzročitelji je opisana v poglavju 4.4.
English: Spray distance from tissue and pressure should be within the ranges recommended by the manufacturer (see table in section Instructions for Use).
Slovenian: Razdalja med pršilnikom in tkivom ter tlak morata biti v razponu, ki ga priporoča izdelovalec (glejte tabelo v poglavju Navodila za uporabo).
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).
Slovenian: Neželeni učinki, ki so se v kliničnih preskušanjih z zdravilom EVICEL pojavljali občasno (tj., pojavijo se lahko pri največ 1 od 100 bolnikov), so vključevali okužbo, nabiranje krvi (hematom), otekanje, znižan hemoglobin in pooperativne zaplete rane (vključno s krvavitvijo ali okužbo).
English: 20°C-25°C (room temperature): vials thaw within 1 hour, 37°C (e.g., water bath, using aseptic technique, or by warming vials in the hand): vials should be thawed within 10 minutes and must not be left at this temperature for longer than 10 minutes or until fully thawed.
Slovenian: 20 °C-25 °C (sobna temperatura): viale se odtalijo v 1 uri, 37 °C (npr. vodna kopel, z aseptično tehniko ali segrevanje v dlani): viale se odtalijo v 10 minutah; pri tej temperaturi jih ne smete pustiti dlje kot 10 minut oziroma dokler se popolnoma ne odtalijo.
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.
Slovenian: Pršilnikom in nastavkom so priložena navodila za uporabo, kjer so navedena priporočila za razpon tlakov in razdaljo od tkivne površine, ki jih morate natančno upoštevati.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Tabela, prikazana spodaj, je v skladu s terminologijo slovarja MedDRA (medicinskega slovarja za regulatorne aktivnosti, angl. Medical Dictionary for Regulatory Activities, MedDRA) na ravni razvrščanja organskih sistemov (angl. System organ classification, SOC) in ravni priporočenega izraza (angl. Preferred Term).
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.
Slovenian: Na škatlo morate zapisati nov datum izteka roka uporabnosti pri 2-8 C, vendar ta novi datum ne sme presegati datuma izteka roka uporabnosti, ki ga je izdelovalec natisnil na škatlo in nalepko.
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.
Slovenian: Vendar pa je sponzor za 3 resne neželene dogodke (en abdominalni absces v skupini z zdravilom EVICEL ter en abdominalni in en medenični absces v kontrolni skupini) menil, da bi lahko bili povezani s preučevanim zdravilom.
English: It is not known whether radiation therapy could affect the efficacy of fibrin sealant when used for suture line sealing in dura mater closure.
Slovenian: Ni znano, ali zdravljenje s sevanjem vpliva na učinkovitost fibrinskega lepila, kadar se ta uporablja za lepljenje šivov pri zapiranju dure.
English: The doctor treating you will administer EVICEL during surgery.
Slovenian: Zdravnik, ki vas zdravi, bo uporabil zdravilo EVICEL med kirurškim posegom.
English: No allergic reactions have so far been reported in patients treated with EVICEL.
Slovenian: Pri bolnikih, ki so jih zdravili z zdravilom EVICEL, doslej še niso opazili alergijskih reakcij.
English: The use of EVICEL is restricted to experienced surgeons who have been trained in the use of EVICEL.
Slovenian: Zdravilo EVICEL lahko uporabljajo le izkušeni kirurgi, usposobljeni za uporabo zdravila EVICEL.
English: Do not apply intravascularly
Slovenian: Ne uporabljajte intravaskularno.
English: Post-operative CSF leakage occurred within 30 days from treatment in 4/89 (4.5%) subjects treated with EVICEL (two cases of CSF leakage with impaired wound healing and two cases of rhinorrhoea) and in 1/50 (2.0%) subjects treated with additional sutures.
Slovenian: Do uhajanja likvorja po posegu je prišlo v 30 dneh po zdravljenju pri 4 od 89 (4,5 %) preiskovancev, zdravljenih z zdravilom EVICEL (dva primera uhajanja likvorja s slabšim celjenjem rane in dva primera rinoreje), in pri 1 od 50 (2,0 %) preiskovancev, zdravljenih z dodatnimi šivi.
English: EVICEL must be sprayed using pressurised CO2 only.
Slovenian: Zdravilo EVICEL smete pršiti samo s CO2 pod tlakom.
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:
Slovenian: Pri nanašanju zdravila EVICEL s pršilnikom se prepričajte, da uporabljate tlak in razdaljo od tkiva v razponih, ki jih priporoča imetnik dovoljenja za promet s tem zdravilom, kot je navedeno v naslednji tabeli:
English: The events were evenly distributed across treatment arms, with 8 each in the EVICEL and the control groups.
Slovenian: Ti dogodki so bili enakomerno porazdeljeni med obe skupini preiskovancev, 8 primerov v skupini bolnikov, ki so jih zdravili z zdravilom EVICEL, in 8 primerov v kontrolni skupini.
English: - Periodic Safety Update Reports
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: • The Healthcare professionals training material shall inform about the o risk of life-threatening gas embolism if the product is sprayed incorrectly o use of pressurized CO2 only o Restriction to open and laparoscopic surgeries, minimum spray distances must be observed:
Slovenian: • Gradivo za izobraževanje, namenjeno zdravstvenemu osebju, bo ozaveščalo o o tveganju za življenjsko nevarno plinsko embolijo, če se zdravilo naprši nepravilno; o uporabi samo s CO2 pod tlakom; o omejitvi uporabe samo za odprte kirurške in laparoskopske postopke, upoštevati je treba najmanjše razdalje naprševanja: - pri odprtih kirurških postopkih je najmanjša razdalja 10 cm,
English: Connect the female luer-lock of the gas tube (with the 0.2 μm bacteriostatic filter) to a pressure regulator.
Slovenian: Ženski priključek luer-lock na cevi za plin (z 0,2-mikrometrskim bakteriostatskim filtrom) priključite na regulator tlaka.
English: Post procedural haematoma Post-operative wound complication
Slovenian: Hematom po posegu Pooperativni zapleti ran
English: It will be dripped onto the tissue in very small amounts or sprayed in short bursts (0.1-0.2 ml), to produce a thin, even layer.
Slovenian: Zdravilo se nakapa na tkivo v majhni količini ali razprši v kratkih razprških (0,1-0,2 ml), da nastane tanek, enakomeren sloj.
English: EVICEL is also indicated in adults as suture support for haemostasis in vascular surgery and for suture line sealing in dura mater closure.
Slovenian: Zdravilo EVICEL je indicirano tudi pri odraslih za podporo šivom za doseganje hemostaze pri žilnih kirurških posegih in za lepljenje šivov pri zapiranju dure.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Slovenian: V redkih primerih se lahko razvijejo protitelesa proti sestavinam fibrinskih lepil/hemostatikov.
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).
Slovenian: Drugi neželeni učinki, o katerih so poročali v kliničnih preskušanjih z zdravilom EVICEL, ki so se pojavili pogosto (tj., pojavijo se lahko pri največ 1 od 10 bolnikov), so vključevali meningitis in nabiranje likvorja v možganskih votlinah (hidrocefalus).
English: Other ingredients are:
Slovenian: Pomožne snovi so:
English: The solutions are clear or slightly opalescent.
Slovenian: Raztopini sta bistri ali rahlo opalescentni.
English: Component 2: Human thrombin 800-1200 IU/ml
Slovenian: Raztopina 2: humani trombin 800-1200 i.e./ml
English: Do not use EVICEL
Slovenian: Ne uporabljajte zdravila EVICEL
English: If you experience an allergic reaction you might have one or more of the following symptoms: skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting, or wheezing.
Slovenian: Če se pri vas pojavi alergijska reakcija, imate lahko enega ali več od naslednjih simptomov: kožni izpuščaj, koprivnica, stiskanje v prsih, mrazenje, zardevanje, glavobol, nizek krvni tlak, stanje podobno globokemu spanju (letargija), slabost, nemir, pospešen utrip srca, mravljinčenje, bruhanje ali sopenje.
English: Discard unused product after 24 hours at room temperature.
Slovenian: Neuporabljeno zdravilo morate po 24 urah pri sobni temperaturi zavreči.
English: What EVICEL looks like and contents of the pack
Slovenian: Izgled zdravila EVICEL in vsebina pakiranja
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g., haemolytic anaemia).
Slovenian: Okužba s parvovirusom B19 je lahko resna pri nosečnicah (okužba ploda) in posameznikih z oslabljenim imunskim sistemom ali povečano eritropoezo (npr. hemolitična anemija).
English: When using accessory tips with this product, the instructions for use of the tips should be followed.
Slovenian: Če uporabljate dodatne nastavke, upoštevajte navodila za njihovo uporabo.
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:
Slovenian: Pri nanašanju zdravila EVICEL s pršilnikom se prepričajte, da uporabljate tlak in razdaljo od tkiva v razponih, ki ju priporoča izdelovalec.
English: Before use, the product must reach 20°C-30°C.
Slovenian: Temperatura zdravila pred uporabo mora biti med 20 °C in 30 °C.
English: Connect the female luer lock of the gas tube (with the 0.2 μm bacteriostatic filter) to a pressure regulator.
Slovenian: Ženski priključek luer lock na cevi za plin (z 0,2-mikrometrskim bakteriostatskim filtrom) priključite na regulator tlaka.
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.
Slovenian: Učinkovitost zdravila EVICEL za lepljenje šivov pri zapiranju dure so dokazali pri 139 bolnikih (89 zdravljenih z zdravilom EVICEL, 50 v kontrolni skupini) po kraniotomiji/kraniektomiji.
English: Component 1: Human clottable protein 50 - 90 mg/ml
Slovenian: Raztopina 1: humana koagulacijska beljakovina 50-90 mg/ml
English: During your operation, your doctor will drip or spray EVICEL onto raw tissue, using an application device.
Slovenian: Med posegom bo zdravnik nakapal ali razpršil zdravilo EVICEL na tkivo z aplikatorjem.
English: Each contains 1 ml, 2 ml or 5 ml solution of human fibrinogen and human thrombin, respectively.
Slovenian: Vsaka vsebuje 1 ml, 2 ml ali 5 ml raztopine humanega fibrinogena oz. humanega trombina.
English: • sealing surgical repairs to the intestines
Slovenian: • lepljenju kirurških korekcij črevesja,
English: EVICEL is a human fibrin sealant which is supplied as a package containing two separate glass vials.
Slovenian: Zdravilo EVICEL je lepilo iz humanega fibrina, ki je voljo v pakiranju z dvema steklenima vialama.
English: These included intracranial hypotension (CSF leakage), CSF rhinorrhea, meningitis, headache, hydrocephalus, subdural hygroma, and haematoma.
Slovenian: Ti učinki so bili intrakranialna hipotenzija (uhajanje likvorja), likvorska rinoreja, meningitis, glavobol, hidrocefalus, subduralni higrom in hematom.