FrancophonIA/ELRC3.0 huggingface dataset:
English: The fibrin is then cross-linked by endogenous Factor XIII, creating a firm, mechanically stable fibrin network with good adhesive properties.
Croatian: Fibrin se potom križno povezuje s endogenim faktorom XIII i tako tvori čvrstu, mehanički stabilnu fibrinsku mrežu s dobrim adhezivnim svojstvima.
English: It is applied directly onto tissue where it sticks firmly and stops bleeding.
Croatian: Primjenjuje se izravno na tkivo gdje se čvrsto lijepi i zaustavlja krvarenje.
English: In contact with physiological fluids, e.g., blood, lymph, or physiological saline, the components of the coating are activated, and the reaction of fibrinogen and thrombin initiates the last phase of physiological blood coagulation.
Croatian: U dodiru s fiziološkim tekućinama, primjerice krvlju, limfom ili fiziološkom otopinom, sastojci obloge se aktiviraju i reakcija fibrinogena i trombina započinje posljednju fazu fiziološkog zgrušavanja krvi.
English: Human fibrinogen (8.1 mg/cm2) Human thrombin (40 IU/ cm2)
Croatian: - ljudski fibrinogen (8,1 mg / cm2) - ljudski trombin (40 IU/ cm2)
English: Discard damaged packages as re-sterilisation is not possible.
Croatian: Oštećena pakiranja odložite u otpad jer ponovna sterilizacija pripravka nije moguća.
English: Discard damaged packages.
Croatian: Oštećena pakiranja bacite.
English: The product should only be administered according to the instructions recommended for this product (see section 6.6).
Croatian: Lijek treba primijeniti samo u skladu s uputama za ovaj lijek (vidjeti dio 6.6).
English: In the integrated analyses, 381 patients were treated with EVARREST and 272 patients were treated with control treatment.
Croatian: U integriranim analizama, u 381 bolesnika primijenjen je EVARREST, a u 272 bolesnika kontrolno liječenje.
English: For safety with respect to transmissible agents, see section 4.4.
Croatian: Za sigurnost obzirom na prenosive uzročnike vidjeti dio 4.4.
English: Blood clots, including those clots that may travel in blood vessels to other parts of the body, particularly the lungs (pulmonary embolus) may occur after any major surgery.
Croatian: Krvni ugrušci, uključujući one ugruške koji mogu putovati u krvnim žilama u druge dijelove tijela, posebice u pluća (plućni embolus) mogu se javiti nakon bilo kojeg većeg kirurškog zahvata.
English: Due to the nature of surgical procedures and the physiological response to surgical trauma all surgical subjects are at risk for occurrence of thromboembolism.
Croatian: Zbog prirode kirurških zahvata i fiziološkog odgovora na kiruršku traumu svi su kirurški ispitanici imaju rizik od pojave tromboembolije.
English: Foreign body reactions
Croatian: Reakcije na strano tijelo
English: Of the enrolled subjects, 4.7% of EVARREST treated subjects (18 subjects out of 381) and 2.6% of control subjects (7 subjects out of 272) experienced one or more adverse reactions.
Croatian: Od uključenih ispitanika 4,7 % ispitanika s primijenjenim EVARREST-om (18 ispitanika od njih 381) te 2,6 % kontrolnih ispitanika (7 ispitanika od njih 272) iskusilo je jednu ili više nuspojava.
English: It is left in place and is absorbed by the body in approximately 8 weeks.
Croatian: Ostavlja se na mjestu te se resorbira za približno 8 tjedana.
English: Fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction.
Croatian: Fibrinska tkivna ljepila mogu u rijetkim slučajevima (u do 1 na 1000 osoba) uzrokovati alergijsku reakciju.
English: The foil sachet protects EVARREST from moisture and from microbiological contamination.
Croatian: Folijska vrećica štiti EVARREST od vlage i mikrobiološkog onečišćenja.
English: There is not enough information available to know whether any particular risks are associated with the use of EVARREST during pregnancy or whilst breast-feeding, or whether it could affect fertility.
Croatian: Nema dovoljno dostupnih podataka o postojanju bilo kakvih posebnih rizika povezanih s primjenom lijeka EVARREST tijekom trudnoće ili za vrijeme dojenja te bi li njena primjena mogla utjecati na plodnost.
English: EVARREST should only be used in a single layer.
Croatian: EVARREST se smije koristiti samo u jednom sloju.
English: The Matrix provides physical support and a large surface area for the biological components, imparts inherent mechanical integrity to the product and supports clot formation.
Croatian: Matrica daje fizičku potporu i veliko površinsko područje za biološke komponente, utječe na inherentni mehanički integritet lijeka i podržava stvaranje ugruška.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with EVARREST in one or more subsets of the paediatric population for the treatment of haemorrhage resulting from a surgical procedure (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja matrice EVARREST u jednoj ili više podskupina pedijatrijske populacije u kod liječenja krvarenja koje nastaje kao rezultat kirurških postupaka (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: EVARREST can be used in an actively bleeding field.
Croatian: EVARREST se može koristiti na području aktivnog krvarenja.
English: If these symptoms occur during surgery, the use of the product should be stopped immediately.
Croatian: Ako se ti simptomi pojave za vrijeme kirurškog zahvata, nužno je odmah zaustaviti primjenu lijeka.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Croatian: Poduzete mjere mogu biti od ograničene vrijednosti protiv virusa bez ovojnice poput parvovirusa B19.
English: Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15 1831 Diegem
Croatian: Omrix Biopharmaceuticals NV Leonardo Da Vincilaan 15 1831 Diegem
English: Allergic-type hypersensitivity reactions are possible.
Croatian: Moguće su alergijske reakcije preosjetljivosti.
English: Keep EVARREST dry after opening.
Croatian: Držite EVARREST suhim nakon otvaranja.
English: ● Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: If these symptoms occur, the product should be removed immediately and other hemostatic agent or methods should be used.
Croatian: U slučaju pojave ovih simptoma, Evarrest je potrebno odmah ukloniti i primijeniti druge hemostatike ili metode za postizanje hemostaze.
English: There is a also a theoretical possibility that you could develop antibodies to the proteins in EVARREST, which could potentially interfere with blood clotting.
Croatian: Postoji teorijska mogućnost razvoja protutijela na proteine u lijeku EVARREST koji bi mogli interferirati sa zgrušavanjem krvi.
English: Do not use after the expiry date stated on the carton and label.
Croatian: Nemojte koristiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici.
English: The surgeon will apply EVARREST during your operation.
Croatian: Kirurg će primijeniti EVARREST tijekom kirurškog zahvata.
English: The safety data for EVARREST reflect the types of post-operative complication generally related to the surgical settings in which the trials were conducted and the underlying disease of the patients.
Croatian: Podaci o sigurnosti lijeka EVARREST odražavaju tipove postoperacijskih komplikacija koje su općenito povezane s kirurškim uvjetima u kojem su ispitivanja provedena te o postojećoj bolesti bolesnika.
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).
Croatian: Slično kao i drugi usporedivi lijekovi ili otopine trombina, lijek se može denaturirati nakon izloženosti otopinama koje sadrže alkohol, jod ili teške metale (primjerice, otopine antiseptika).
English: A 90-day study in rats to evaluate subchronic systemic toxicity and immunogenicity of EVARREST after subcutaneous implantation found no signs of toxic effects and no evidence of increased immunogenicity relative to fibrin sealant products.
Croatian: Devedesetodnevno ispitivanje na štakorima kako bi se procijenila subkronična sistemska toksičnost i imunogenost lijeka EVARREST nakon supkutane implantacije nije otkrila znakove toksičnih učinaka i dokaz povećane imunogenosti povezane s fibrinskim tkivnim ljepilima.
English: What EVARREST is and what it is used for
Croatian: Što je EVARREST i za što se koristi
English: Other medicines and EVARREST
Croatian: Drugi lijekovi i EVARREST
English: Read this before you open the package
Croatian: Prije otvaranja pakiranja pročitajte ove upute
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/868/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/868/001
English: EVARREST is intended for epilesional use only.
Croatian: EVARREST je namijenjen samo za epilezijsku primjenu.
English: Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section
Croatian: Potporna terapija kod kirurških zahvata u odraslih osoba kada standardne kirurške tehnike nisu dostatne (vidjeti dio 5.1):
English: Fibrin sealants/haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Croatian: Fibrinska tkivna ljepila/hemostatici metaboliziraju se na isti način kao i endogeni fibrin, fibrinolizom i fagocitozom.
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.
Croatian: Ispitivanja su provedena na kunićima kako bi se procijenila apsorpcija i eliminacija trombina prilikom primjene na površinu rane na jetri koja je bila rezultat parcijalne hepatektomije.
English: Applications for which adequate data are not available Adequate data are not available to support the use of this product in neurosurgery or application through a flexible endoscope for treatment of bleeding, in vascular surgery, or in gastrointestinal anastomoses.
Croatian: Primjene za koje nisu dostupni odgovarajući podaci Nisu dostupni odgovarajući podaci koji bi poduprli primjenu ovog lijeka u neurokirurgiji ili za liječenje krvarenja pri fleksibilnoj endoskopiji, u vaskularnoj kirurgiji ili kod gastrointestinalnih anastomoza.
English: As with any product which is implanted, the body may develop a reaction to the foreign material.
Croatian: Kao sa svakim usađenim lijekom, tijelo može razviti reakciju na strani materijal.
English: The overall incidence of deep vein thrombosis observed during clinical trials was consistent with published data and does not suggest an increased risk for thrombotic events in EVARREST-treated subjects, although from the available data, this risk cannot be completely ruled out.
Croatian: Ukupna incidenciju duboke venske tromboze uočene tijekom kliničkih ispitivanja bila je u skladu s objavljenim podacima i ne ukazuje na povećani rizik od trombotičkih događaja kod ispitanika s primijenjenim EVARREST-om, iako prema dostupnim podacima nije moguće u potpunosti isključiti taj rizik.
English: Component 2 Human Thrombin
Croatian: Komponenta 2: ljudski trombin
English: Medicinal products on “restricted” medical prescription, reserved for use in certain specialised areas (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na “ograničeni” recept i namijenjen je za uporabu u određenim specijaliziranim područjima (vidjeti Prilog I: Sažetak opisa svojstava lijeka, dio 4.2).
English: As with any protein containing product, allergic-type hypersensitivity reactions are possible.
Croatian: Kao i sa svakim proteinskim lijekom, moguće su alergijske reakcije preosjetljivosti.
English: EVARREST should not be used in place of sutures or other forms of mechanical ligation for the treatment of major arterial bleeding.
Croatian: EVARREST se ne smije koristiti umjesto šavova ili drugih oblika mehaničkog podvezivanja radi zaustavljanja velikog arterijskog krvarenja.
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.
Croatian: Doza koja će se primijeniti ovisi o promjenjivim čimbenicima koji uključuju ali se ne ograničavaju na vrstu kirurškog zahvata, veličinu područja na koje se nanosi i svrhu primjene te broj primjena.
English: The incidence of thromboembolic events, the incidence of post-operative bleeding events specifically related to the target bleeding site and the incidence of increased blood fibrinogen levels were assessed and recorded up to the 30 days follow-up period.
Croatian: Procijenjene su incidencija tromboembolijskih događaja, incidencija postoperacijskih krvarenja koja su specifično povezana s ciljnim mjestom krvarenja i incidencija povišenih razina fibrinogena u krvi te su bilježene do 30 dana razdoblja praćenja.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere sprječavanja infekcija koje su rezultat uporabe lijekova koji se dobivaju iz ljudske krvi ili plazme uključuje selekciju donora, probir pojedinačnih donacija i pulova plazme (plasma pools) na specifične markere infekcije i uključivanje djelotvornih postupaka za inaktivaciju/uklanjanje virusa tijekom proizvodnje.
English: This could result in problems with healing.
Croatian: To može uzrokovati probleme u cijeljenju.
English: Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.4).
Croatian: Tromboembolijske komplikacije se mogu javiti kod nehotične intravaskularne primjene pripravka (vidjeti dio 4.4).
English: The haemostatic efficacy of EVARREST was demonstrated in a number of animal models assessing time to haemostasis and post-treatment blood loss, among other endpoints.
Croatian: Hemostatska djelotvornost matrice EVARREST dokazana je na brojnim životinjskim modelima na kojima je procjenjivano vrijeme do hemostaze i gubitak krvi nakon liječenja, među ostalim mjerama ishoda.
English: 5a) Hold dry or moist surgical gauze or laparotomy pads over EVARREST to achieve full contact with the bleeding surface.
Croatian: 5a) Držite suhu ili vlažnu kiruršku gazu ili laparotomijske jastučiće preko lijeka EVARREST kako bi se postigao puni kontakt s površinom koja krvari.
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.
Croatian: Eksperimentalna ispitivanja na životinjama su nedostatna za procjenu sigurnosti s obzirom na reprodukciju, razvoj embrija ili fetusa, tijek trudnoće, perinatalni i postnatalni razvoj.
English: After the biologic components have been absorbed, the Matrix components (polyglactin 910 and oxidized regenerated cellulose) absorb completely.
Croatian: Nakon apsorpcije bioloških komponenti, komponente matriksa (poliglaktin 910 i oksidirana regenerirana celuloza) apsorbiraju se u potpunosti.
English: The clot formation of EVARREST is integrated with the Matrix; it forms a mechanical barrier to bleeding and reinforces the wound site.
Croatian: Ugrušak nastao pomoću lijeka EVARREST integrira se s matricom; formira mehaničku barijeru krvarenju te ojačava mjesto rane.
English: The amount of EVARREST to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
Croatian: Količina EVARREST-a koja će se primijeniti i učestalost njegovog nanošenja uvijek mora odrediti prema postojećim kliničkim potrebama bolesnika.
English: When the dry powder coating of EVARREST is wetted, the thrombin acts on the fibrinogen to rapidly form a clot.
Croatian: Kad se suhi prašak kojim je obložen EVARREST namoči, trombin djeluje na fibrinogen kako bi se ubrzano stvorio ugrušak.
English: In clinical trials, the most frequently reported adverse reactions were haemorrhage and increased fibrinogen, and the most serious adverse reactions were aspiration, pulmonary embolism, and haemorrhage.
Croatian: U kliničkim ispitivanjima najčešće prijavljene nuspojave bile su krvarenje i povećana razina fibrinogena, a najozbiljnije nuspojave bile su aspiracija, embolija pluća i krvarenje.
English: Fibrinogen is converted into fibrin monomers which spontaneously polymerise to form a fibrin clot that holds the Matrix firmly to the wound surface.
Croatian: Fibrinogen se konvertira u monomere fibrina koji se spontano polimeriziraju tvoreći fibrinski ugrušak koji čvrsto drži matricu na površini rane.
English: ● EVARREST must not be used in the presence of active infection or in contaminated areas of the body because infection may occur.
Croatian: ● EVARREST se ne smije koristiti u prisutnosti aktivne infekcije ili u kontaminiranim područjima tijela jer može nastati infekcija.
English: Remove excess blood or fluid from the site of application if required to improve visibility.
Croatian: Ako je potrebno uklonite višak krvi ili tekućine s mjesta primjene kako biste poboljšali vidljivost.
English: Non-clinical data on the Matrix component reveal no special hazard for humans based on studies of cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, subchronic toxicity, genotoxicity, implantation, and hemocompatibility.
Croatian: Neklinički podaci o komponenti matrice ne ukazuju na poseban rizik za ljude na temelju ispitivanja citotoksičnosti, senzibilizacije, intrakutane reaktivnosti, akutne sistemske toksičnosti, pirogenosti uzrokovane materijalom, subkronične toksičnosti, genotoksičnosti, implantacije i hemokompatibilnosti.
English: EVARREST comes ready to use in sterile packages and must be handled using sterile technique in aseptic conditions.
Croatian: EVARREST se isporučuje spreman za primjenu u sterilnim pakiranjima te se njime mora rukovati koristeći sterilne tehnike u aseptičkim uvjetima.
English: • Risk Management Plan (RMP) The Marketing Authorization 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.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: Telephone: +32 2 746 30 00 Telefax: + 32 2 746 30 01
Croatian: Telefon: +32 2 746 30 00 Telefaks: + 32 2 746 30 01
English: Life-threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Croatian: Po život opasne tromboembolijske komplikacije mogu nastati ako se pripravak nehotično primjeni intravaskularno.
English: EVARREST must not be used in the presence of active infection or in contaminated areas of the body because infection may occur.
Croatian: EVARREST se ne smije primjenjivati u prisutnosti aktivne infekcije ili u kontaminiranim područjima tijela jer može nastati infekcija.
English: Immunogenicity was evaluated in soft tissue clinical studies by testing blood samples collected at baseline, 4 to 6 weeks, and 8 to 10 weeks post-surgery for antibodies to human thrombin and fibrinogen by enzyme-linked immunosorbent assays.
Croatian: Imunogenost je procijenjena u kliničkim ispitivanjima mekog tkiva testiranjem uzoraka krvi prikupljenih na početku, 4 do 6 tjedana te 8 do 10 tjedana nakon kirurškog zahvata na protutijela na ljudski trombin i fibrinogen ELISA testom.
English: Human Fibrinogen
Croatian: ljudski fibrinogen
English: If you experience any of these symptoms after surgery you should consult your doctor or surgeon.
Croatian: Ako nakon kirurškog zahvata osjetite bilo koji od ovih simptoma, morate se obratiti svom liječniku ili kirurgu.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped virus hepatitis A virus (HAV).
Croatian: Poduzete mjere smatraju se djelotvornim za viruse s ovojnicom poput virusa humane imunodeficijencije (HIV), hepatitisa B (HBV) i virusa hepatitisa C (HCV) te za virus bez ovojnice poput virusa hepatitisa A (HAV).
English: Telefax: +972-3-5316590
Croatian: Telefaxs: +972-3-5316590
English: EVARREST contains Human Fibrinogen and Human Thrombin as a dried coating on the surface of an absorbable composite Matrix.
Croatian: EVARREST sadrži humani fibrinogen i humani trombin kao suhi sloj na površini kompozitnog resorptivnog matriksa.
English: This should be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir u bolesnika na dijeti s kontroliranim unosom soli.
English: Fibrinogen is a protein extracted from the blood that forms a fibrin clot when acted upon by the enzyme thrombin.
Croatian: Fibrinogen je protein dobiven iz krvi koji tvori fibrinski ugrušak djelovanjem enzima trombina.
English: If you experience any symptoms such as vomiting with blood, blood in your stool, blood in your draining tube from your abdomen, swelling or skin discolouration in your extremities, chest pain and shortness of breath, and/or any other symptoms related to your surgery, please contact your doctor or surgeon immediately.
Croatian: Ako ste primijetili bilo koji simptom poput povraćanja krvi, krvi u stolici, krvi u drenažnoj cijevi iz Vašeg trbuha, oticanja ili promjene boje kože Vaših udova, boli u prsima i nedostatka zraka i/ili bilo koje druge simptome koji su povezani s Vašim kirurškim zahvatom, obratite se odmah svom liječniku ili kirurgu.
English: It is strongly recommended that every time you are treated with EVARREST, the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Croatian: Osobito se preporučuje da se svaki put prilikom liječenja lijekom EVARREST zabilježi naziv i broj serije lijeka kako bi se održao zapis primjenjenih serija.
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.
Croatian: Takve reakcije se mogu posebice uočiti kod opetovane primjene pripravka, ili ako se primjenjuje bolesnicima za koje je utvrđeno da su preosjetljivi na sastojke lijeka.
English: The fibrin clot becomes embedded in the Matrix which enables EVARREST to stick firmly to the surrounding tissue.
Croatian: Fibrinski ugrušak ugrađuje se u matrica koji omogućava da se EVARREST čvrsto zalijepi na okolno tkivo.
English: EVARREST is applied during surgical operations in adult subjects, to stop bleeding and oozing during the operation.
Croatian: EVARREST se primjenjuje tijekom kirurških zahvata na odraslim bolesnicima kako bi se zaustavilo krvarenje i curenje iz rane tijekom zahvata.
English: Telephone: +972-3-5316512
Croatian: Telefon: +972-3-5316512
English: Therefore, the product should be administered to pregnant and lactating women only if clearly needed.
Croatian: Stoga se EVARREST smije primjenjivati tijekom trudnoće i dojenja samo ako je to neophodno.
English: EVARREST does not stick to gloves, forceps, or surgical instruments.
Croatian: EVARREST se ne lijepi za rukavice, hvataljke ili kirurške instrumente.
English: Omrix Biopharmaceuticals Ltd. Jerusalem Plant (Omrix-JP) 5 Kiryat Hamada St., Ramot Meir Building Har-Hotzvim P.O.B.
Croatian: Jerusalem Plant (Omrix-JP) 5 Kiryat Hamada St., Ramot Meir Building Har-Hotzvim P.O.B. 45075 Jerusalem 9777605
English: The active side of the sealant matrix is powdery, and the non-active side has an embossed wave pattern.
Croatian: Djelatna strana matrice za tkivno ljepilo je praškasta, a nedjelatna strana ima utisnuti valoviti uzorak.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Komponenta 1: ljudski fibrinogen