natgillin/translations-raw huggingface dataset:
Therefore, the product should be administered to pregnant and breast-feeding women only if clearly needed.
Zato se sme zdravilo EVICEL uporabljati pri nosečnicah in doječih materah samo, kadar je to nedvomno potrebno.
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.
Vse koncentracije kombinacije TnBP in Tritona X100 so dale negativen rezultat tudi v testih za ugotavljanje mutagenosti za celice sesalcev, kromosomskih aberacij in indukcije mikronukleusa.
Factor XIIIa, which is activated from Factor XIII by thrombin, crosslinks fibrin.
Trombin aktivira faktor XIII v faktor XIIIa, ta pa navzkrižno poveže fibrin.
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.
Za nanašanje razpršila glejte poglavji 4.4 in 6.6, ki vsebujeta posebna priporočila v zvezi z zahtevanim tlakom in razdaljo od tkiva glede na kirurški poseg in dolžino konice aplikatorja.
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.
Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, so selekcija darovalcev, presejanje posameznih odvzetih enot in združene plazme za specifične označevalce okužbe in vključevanje učinkovitih proizvodnih stopenj za inaktivacijo/odstranitev virusov.
The instructions for use are also described in the healthcare professionals package leaflet part.
Navodila za uporabo so opisana tudi v poglavju Informacije za zdravstveno osebje v Navodilu za uporabo.
The following side effects which occurred during clinical studies were considered to be related to the use of EVICEL:
Za naslednje neželene učinke, ki so se pojavili med kliničnimi študijami, je bilo ocenjeno, da bi utegnili biti vzročno povezani z uporabo zdravila EVICEL:
An application device and appropriate accessory tips are supplied separately.
Ločeno so na voljo aplikator in ustrezni nastavki.
The use of EVICEL in patients undergoing radiotherapy within 7 days after surgery has not been evaluated.
Uporaba zdravila EVICEL pri bolnikih, ki so se sedem dni po posegu zdravili z radioterapijo, ni bila ovrednotena.
As with any protein product, allergic type hypersensitivity reactions are possible.
Kot pri vseh beljakovinskih zdravilih so možne preobčutljivostne reakcije alergijskega tipa.
The fibrinogen and thrombin components are stable at room temperature for up to 24 hours.
Sestavini fibrinogen in trombin sta pri sobni temperaturi stabilni do 24 ur.
Do not use solutions that are cloudy or have deposits.
Ne uporabite raztopin, ki so motne ali imajo usedline.
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:
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo v vsaki državi članici, kjer se zdravilo Evicel trži, zdravstveni delavci, ki uporabljajo zdravilo Evicel, prejeli izobraževalni paket, namenjen širjenju ozaveščenosti otveganju za življenjsko nevarno plinsko embolijo, če se zdravilo naprši nepravilno, in za zagotavljanje smernic za zmanjšanje tega tveganja:
The safety of fibrin sealants/haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Varnost uporabe fibrinskih lepil/hemostatikov pri ženskah med nosečnostjo ali dojenjem ni potrjena z nadzorovanimi kliničnimi preskušanji.
Fibrinogen is a concentrate of clottable protein and thrombin is an enzyme that causes clottable protein to coalesce.
Fibrinogen je koncentrat koagulacijske beljakovine, trombin pa encim, ki vpliva na koagulacijsko beljakovino tako, da ta tvori strdke.
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.
Komponenti fibrinogena in trombina sta stabilni pri sobni temperaturi do 24 ur, po vnosu v aplikator pa ju morate porabiti nemudoma.
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.
V kontroliranih kliničnih preskušanjih v žilni kirurgiji je bil volumen posameznega odmerka do 4 ml; pri lepljenju šivov za zapiranje dure so uporabljali odmerke do 8 ml, pri retroperitonealnih ali intraabdominalnih kirurških posegih pa je bil volumen posameznega odmerka do 10 ml.
Decreased haemoglobin
Znižan hemoglobin
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.
Ukrepi, ki se izvajajo, štejejo za učinkovite proti virusom z ovojnico, kot so HIV, virus hepatitisa C in virus hepatitisa B, ter proti virusu hepatitisa A, ki je brez ovojnice.
There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.
Obstaja teoretična možnost, da pri vas nastanejo protitelesa proti beljakovinam v zdravilu EVICEL, kar lahko moti strjevanje krvi.
Neurobehavioral observations for 14±1 days showed no abnormal findings.
Pri spremljanju nevrovedenjskih lastnosti v obdobju 14±1 dni niso opazili nenormalnosti.
Fibrin sealants/haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Fibrinska lepila/hemostatiki se presnavljajo na enak način kot endogeni fibrin - s fibrinolizo in fagocitozo.
EVICEL can also be used to support the watertight closure of the cerebral envelopes (dura mater) during neurosurgery when other surgical techniques are insufficient.
Zdravilo EVICEL se lahko uporabi tudi za podporo neprepustnemu zapiranju možganskih ovojnic (dure) med nevrokirurškim posegom, kadar druge kirurške tehnike niso dovolj.
EVICEL is indicated in adults as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis (see section 5.1).
Zdravilo EVICEL je indicirano kot podporno zdravljenje za izboljšanje hemostaze pri kirurških posegih, kjer standardne kirurške tehnike ne zadoščajo (glejte poglavje 5.1).
• controlling bleeding in the stomach or intestines by applying the product through an endoscope (tube)
• nadzoru krvavitev v želodcu ali črevesju z apliciranjem prek endoskopa (cevke),
• surgery to the brain or spinal cord except for support of watertight closure of cerebral envelopes (dura mater)
• kirurških posegih na možganih ali hrbtenjači, razen za podporo neprepustnemu zapiranju možganskih ovojnic (dure),
4 - 10 cm (1.6 - 4 in)
4-10 cm (1,6-4 palce)
Component 2 Human thrombin
Raztopina 2 humani trombin
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.
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.
The product should only be administered according to the instructions and with the devices recommended for this product (see section 6.6).
Zdravilo se sme nanašati po navodilih in s pripomočki, priporočenimi za to zdravilo (glejte poglavje 6.6).
The incidence of CSF leakage and the incidence of Surgical Site Infections were monitored as safety endpoints in the study.
Pojavnost uhajanja likvorja in pojavnost okužb kirurškega mesta so v študiji spremljali kot varnostna opazovana dogodka.
The frequency of the effects listed above was common (may affect up to 1 in 10 people).
Zgoraj navedeni neželeni učinki so bili pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov).
Other medicines and EVICEL
Druga zdravila in zdravilo EVICEL
Human clottable protein containing mainly fibrinogen and fibronectin *
Raztopina 1 humana koagulacijska beljakovina, ki vsebuje predvsem fibrinogen in fibronektin*
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.
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.
Do not re-freeze.
Ne zamrzujte ponovno.
• EVICEL should not be used in endoscopic surgery.
• Zdravila EVICEL se ne sme uporabljati pri endoskopskih kirurških posegih.
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.
Opravljene so bile študije na kuncih, da bi ovrednotili absorpcijo in eliminacijo trombina po nanosu na rezano površino jeter po delni hepatektomiji.
Neurotoxicity studies performed with EVICEL confirmed that subdural administration in the rabbit was not associated with any evidence of neurotoxicity.
Študije nevrotoksičnosti zdravila EVICEL so potrdile, da subduralna uporaba pri kuncih ni povezana z dokazi nevrotoksičnosti.
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.
Uporabljeni odmerek je odvisen od spremenljivk, ki so med drugim vrsta kirurškega posega, velikost področja, način nameravane aplikacije in število nanosov.
EVICEL spray application should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy.
Zdravilo EVICEL se s pršenjem lahko nanaša le, kadar je mogoče natančno presoditi razdaljo od pršilnika, zlasti med laparoskopijo.
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).
Nenamerno intravaskularno injiciranje lahko povzroči tromboembolični dogodek in diseminirano intravaskularno koagulacijo, prav tako pa obstaja tveganje za anafilaktično reakcijo (glejte poglavje
• gluing tissues together
• lepljenju tkiv skupaj,
Draw the contents of the two vials into the application device, following the instructions for use in the device package.
Posesajte vsebino obeh vial v aplikator po navodilih, ki so priložena aplikatorju.
EVICEL must not be injected into tissue or blood vessels because it would cause clots which could be fatal.
Zdravila EVICEL se ne sme injicirati v tkivo ali žile, ker lahko povzroči tvorbo strdkov, ki lahko povzročijo smrt.
Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process.
Če je strdek predebel, lahko to negativno vpliva na učinkovitost zdravila in na proces celjenja rane.
Safety monitoring focused on the specific adverse reactions of graft patency, thrombotic events, and bleeding events.
Varnostno spremljanje se je osredotočilo na specifične neželene učinke, kot so prehodnost presadka, trombotični dogodki in krvavitve.
5 How to store EVICEL Contents of the pack and other information
5 Shranjevanje zdravila EVICEL Vsebina pakiranja in dodatne informacije
If you get any side effects, talk to your doctor , pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
EVICEL is applied in adults during surgical operations to reduce bleeding and oozing during and after the operation.
Zdravilo EVICEL se uporablja pri odraslih med kirurškimi posegi za zmanjšanje krvavitev in izcejanja med posegom in po njem.
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).
Tako kot podobna zdravila ali raztopine trombina lahko zdravilo EVICEL denaturirajo raztopine z alkoholom, jodom ali težkimi kovinami (npr. antiseptiki).
• 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.
• Uporaba zdravila EVICEL pri nevrokirurškem posegu pri bolnikih, ki se zdravijo tudi s presadki ali duralnimi presadki, v kliničnih študijah ni bila preučena.
• When EVICEL is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue.
• Ko kirurg uporabi zdravilo EVICEL med kirurškim posegom, mora paziti, da ga nanese samo na površino tkiva.
Laparoscopic procedures
Laparoskopski posegi
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).
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) .
The active ingredients are as follows:
Učinkovine so naslednje:
Before use, the product must reach 20-30°C.
Temperatura zdravila pred uporabo mora biti med 20 in 30 °C.
If these symptoms occur, the administration should be discontinued immediately.
Če se pojavijo ti simptomi, je treba uporabo nemudoma prekiniti.
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.
Če nastavek aplikatorja karseda približate površini tkiva, vendar se tkiva med nanašanjem ne dotikate, lahko na želena področja nanašate posamezne kapljice zdravila.
The use of EVICEL as a sealant in transphenoidal and otoneurosurgical procedures has not been studied.
Uporaba zdravila EVICEL kot lepila pri transfenoidnih in otonevrokirurških posegih ni bila preučena.
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.
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.
For instructions on preparation of the medicinal product before administration, see section 6.6.
Za navodila glede priprave zdravila pred nanosom glejte poglavje 6.6.
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.
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.
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.
Ker pa se zdravilo EVICEL uporablja med kirurškim posegom, se o splošnem tveganju posega med nosečnostjo oz. dojenjem posvetujte z zdravnikom.
What EVICEL is and what it is used for What you need to know before you use EVICEL How to use EVICEL
Kaj je zdravilo EVICEL in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo EVICEL Kako uporabljati zdravilo EVICEL Možni neželeni učinki
• It is not known whether radiation therapy could affect the effectiveness of fibrin sealant when used for suture line sealing during neurosurgery.
• Ni znano, ali zdravljenje s sevanjem vpliva na učinkovitost fibrinskega lepila, kadar se ta uporablja za lepljenje šivov pri nevrokirurškem posegu.
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.
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.
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.
Zelo priporočljivo je, da ob vsaki uporabi zdravila EVICEL zabeležite ime in serijsko številko zdravila, da se vzdržuje sledljivost med bolnikom in serijo zdravila.
For safety with respect to transmissible agents, see section 4.4.
Varnost pred prenosljivimi povzročitelji je opisana v poglavju 4.4.
Spray distance from tissue and pressure should be within the ranges recommended by the manufacturer (see table in section Instructions for Use).
Razdalja med pršilnikom in tkivom ter tlak morata biti v razponu, ki ga priporoča izdelovalec (glejte tabelo v poglavju Navodila za uporabo).
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).
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).
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.
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.
Spray devices and accessory tips provide instructions for use with recommendations for pressure ranges and proximity to tissue surface, which should be carefully followed.
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.
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
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).
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.
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.
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.
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.
It is not known whether radiation therapy could affect the efficacy of fibrin sealant when used for suture line sealing in dura mater closure.
Ni znano, ali zdravljenje s sevanjem vpliva na učinkovitost fibrinskega lepila, kadar se ta uporablja za lepljenje šivov pri zapiranju dure.
The doctor treating you will administer EVICEL during surgery.
Zdravnik, ki vas zdravi, bo uporabil zdravilo EVICEL med kirurškim posegom.
No allergic reactions have so far been reported in patients treated with EVICEL.
Pri bolnikih, ki so jih zdravili z zdravilom EVICEL, doslej še niso opazili alergijskih reakcij.
The use of EVICEL is restricted to experienced surgeons who have been trained in the use of EVICEL.
Zdravilo EVICEL lahko uporabljajo le izkušeni kirurgi, usposobljeni za uporabo zdravila EVICEL.
Do not apply intravascularly
Ne uporabljajte intravaskularno.
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.
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.
EVICEL must be sprayed using pressurised CO2 only.
Zdravilo EVICEL smete pršiti samo s CO2 pod tlakom.
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:
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:
The events were evenly distributed across treatment arms, with 8 each in the EVICEL and the control groups.
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.
- Periodic Safety Update Reports
• Redno posodobljena poročila o varnosti zdravila (PSUR)
• 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:
• 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,
Connect the female luer-lock of the gas tube (with the 0.2 μm bacteriostatic filter) to a pressure regulator.
Ženski priključek luer-lock na cevi za plin (z 0,2-mikrometrskim bakteriostatskim filtrom) priključite na regulator tlaka.
Post procedural haematoma Post-operative wound complication
Hematom po posegu Pooperativni zapleti ran
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.
Zdravilo se nakapa na tkivo v majhni količini ali razprši v kratkih razprških (0,1-0,2 ml), da nastane tanek, enakomeren sloj.
EVICEL is also indicated in adults as suture support for haemostasis in vascular surgery and for suture line sealing in dura mater closure.
Zdravilo EVICEL je indicirano tudi pri odraslih za podporo šivom za doseganje hemostaze pri žilnih kirurških posegih in za lepljenje šivov pri zapiranju dure.
Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
V redkih primerih se lahko razvijejo protitelesa proti sestavinam fibrinskih lepil/hemostatikov.