FrancophonIA/ELRC3.0 huggingface dataset:
English: Two subjects out of 145 (~1%) in the group treated with EVARREST showed a transient increase in fibrinogen antibody titres, with titre levels back at background levels at the 8 to 10 week time point.
Croatian: Dva ispitanika od 145 (približno 1 %) u skupini s primijenjenim EVARREST-om pokazali su prolazni porast u titrima protutijela na fibrinogen s razinama titra koje su se vratile na osnovne razine u vremenskim točkama 8 i 10. tjedna.
English: It can be cut to the size and shape required to fit the size of the bleeding area.
Croatian: Može se izrezati na potrebnu veličinu i oblik kako bi pristajao veličini područja krvarenja.
English: EVARREST must be kept out of the sight and reach of children.
Croatian: EVARREST se mora čuvati izvan pogleda i dohvata djece.
English: When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Croatian: Prilikom dobivanja lijekova iz ljudske krvi ili plazme provode se određene mjere radi sprječavanje prijenosa infekcija na bolesnike.
English: The lower portion of the tray contains EVARREST with the active side facing downwards.
Croatian: Niži dio plitice sadrži EVARREST s djelatnom stranom okrenutom prema dolje.
English: If haemostasis is not reached with one application of EVARREST, re-treatment may be administered.
Croatian: Ako se hemostaza ne postigne nanošenjem jednog pripravka EVARREST, možda će biti potrebna ponovna primjena.
English: The use of EVARREST is restricted to experienced surgeons.
Croatian: EVARREST smiju primjenjivati samo iskusni kirurzi.
English: Inspect EVARREST to verify that haemostasis has been achieved and to ensure that there is no crimping over the bleeding area.
Croatian: Pregledajte EVARREST kako biste provjerili da je hemostaza ostvarena i da nema nabiranja preko područja krvarenja.
English: EVARREST must not be used in closed spaces (for example, in, around, or next to openings or passages in the bone or other restricted areas around bone) where it could swell and compress nerves or blood vessels.
Croatian: EVARREST se ne smije koristiti u zatvorenim prostorima (primjerice u, oko ili u blizini koštanih otvora ili prolaza ili drugim ograničenim područjima oko kosti) gdje može nabubriti i pritisnuti živce ili krvne žile.
English: The size of EVARREST should be limited to what is necessary to stop bleeding.
Croatian: Veličinu lijeka EVARREST se mora ograničiti na onu koja je neophodna za prestanak krvarenja.
English: In clinical trials of EVARREST no difference has been observed between EVARREST and control groups with regard to the incidence of thrombotic events, currently suggesting no increased risk with EVARREST use.
Croatian: U kliničkim ispitivanjima EVARREST-a nije uočena razlika između EVARREST-a i kontrolnih skupina s obzirom na incidenciju trombotičkih događaja, što trenutno pokazuje da nema povećanog rizika pri primjeni EVARREST-a.
English: The product can remain in the sterile field to be available for use throughout the procedure.
Croatian: Proizvod može ostati u sterilnom polju kako bi bio dostupan za uporabu tijekom postupka.
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).
Croatian: Infekcija parvovirusom B19 može biti ozbiljna za trudnice (fetalna infekcija) i za one pojedince čiji je imunološki sustav oslabljen ili imaju neku vrstu anemije (primjerice, anemiju srpastih stanica ili hemolitičku anemiju).
English: The bleeding source should be clearly identified and it must be ensured that EVARREST is applied directly onto the bleeding source by covering it completely.
Croatian: Izvor krvarenja se mora jasno identificirati i mora se osigurati postavljanje lijeka EVARREST izravno na izvor krvarenja tako da ga u potpunosti prekrije.
English: It is applied by pressing firmly onto bleeding tissue for approximately 3 minutes.
Croatian: Primjenjuje se čvrstim pritiskom na tkivo koje krvari tijekom približno 3 minute.
English: Anti-thrombin antibodies
Croatian: Protutijela na antitrombin
English: The size of EVARREST should be limited to what is necessary for haemostasis.
Croatian: Veličinu pripravka EVARREST se mora ograničiti na onu koja je potrebna za hemostazu.
English: If you experience an allergic reaction you might have one or more of the following symptoms: swelling under the skin (angioedema), 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.
Croatian: Ako doživite alergijsku reakciju, možete imati jedan ili više sljedećih simptoma: oticanje ispod kože (angioedem), kožni osip, koprivnjaču ili urtike (koprivnjača), stezanje u prsima, zimicu, crvenilo uz osjećaj vrućine, glavobolju, niski krvni tlak, letargiju, mučninu, nemir, ubrzan rad srca, trnce, povraćanje ili piskanje.
English: EVARREST contains the components of fibrin sealant.
Croatian: EVARREST sadrži komponente fibrinskog tkivnog ljepila.
English: Remove the white sterile tray from the pouch and place onto the sterile field.
Croatian: Izvadite bijelu sterilnu pliticu iz vrećice i položite je u sterilno polje.
English: Despite these measures, when medicines prepared from human blood or plasma are given, the possibility of passing on infection cannot be totally excluded.
Croatian: Unatoč ovim mjerama, kad se daju lijekovi pripremljeni iz ljudske krvi ili plazme, ne može se u potpunosti isključiti mogućnost prijenosa infekcije.
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or abnormal erythropoiesis (e.g., haemolytic anaemia).
Croatian: Infekcija parvovirusom B19 može biti ozbiljna za trudnice (fetalna infekcija) i pojedince s imunodeficijencijom ili abnormalnom eritropoezom (primjerice u slučaju hemolitičke anemije).
English: EVARREST is activated upon contact with blood or other fluid and will stick firmly to the tissue.
Croatian: EVARREST se aktivira nakon kontakta s krvlju ili drugim tekućinama te čvrsto prianja uz tkivo.
English: 6.6 Special precautions for disposal and other handling The instructions for use are also described in the in the healthcare professional's package leaflet part.
Croatian: Upute za uporabu također su opisane u uputi o lijeku, u dijelu za zdravstvene radnike.
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/haemostatic products.
Croatian: Preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, žarenje i probadanje na mjestu primjene, bronhospazam, zimicu, crvenilo uz osjećaj vrućine, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsima, trnce, povraćanje, zviždanje u plućima) mogu se javiti u rijetkim slučajevima u bolesnika liječenih fibrinskim tkivnim ljepilima/hemostaticima.
English: The amount of EVARREST that will be applied depends on the surface area and location of the bleeding site to be treated during the operation.
Croatian: Količina lijeka EVARREST koja će se primijeniti ovisi o površini područja i položaju mjesta krvarenja koje će se liječiti tijekom kirurškog zahvata.
English: ● EVARREST must not be used to treat severe bleeding from large defects in large arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST to blood flow and/or pressure during healing and absorption of the product.
Croatian: ● EVARREST se ne smije koristiti u liječenju teškog krvarenja iz velikih oštećenja na velikim arterijama ili venama gdje stijenka ozlijeđene krvne žile zahtijeva zbrinjavanje uz održavanje prohodnosti krvne žile i koje bi rezultiralo trajnom izloženošću lijeku EVARREST krvnoj struji i/ili tlaku tijekom cijeljenja i resorpcije lijeka.
English: EVARREST must not be used after the expiry date which is stated on the foil sachet as well as the carton after EXP.
Croatian: EVARREST se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na folijskoj vrećici kao i na kutiji iza „Rok valjanosti“.
English: The product is activated upon contact with fluid, and adheres and conforms to tissue.
Croatian: Lijek se aktivira u kontaktu s tekućinom, prianja i prilagođava se tkivu.
English: EVARREST can be cut to the size and shape required to fit the size of the bleeding area.
Croatian: EVARREST se može izrezati na potrebnu veličinu i oblik kako bi pristajao veličini područja krvarenja.
English: Most adverse reactions were reported as single events: intra-abdominal haemorrhage, abdominal distension, anaemia, thoracic cavity drainage, pleural effusion, abdominal abscess, ascites, deep vein thrombosis, localized intra-abdominal fluid collection, operative haemorrhage, ischaemic bowel and pulmonary embolism, except blood fibrinogen increased (3 events, 0.8%), anastomotic haemorrhage (3 events, 0.8%), and post procedural haemorrhage (2 events, 0.5%)
Croatian: Većina nuspojava prijavljena je kao pojedinačni događaji: intraabdominalno krvarenje, distenzija abdomena, anemija, drenaža torakalne šupljine, pleuralni izljev, abdominalni apsces, ascites, duboka venska tromboza, lokalizirano nakupljanje tekućine u abdomenu, krvarenje tijekom kirurškog zahvata, embolija crijeva i pluća s ishemijom, iznimno povišenje razine fibrinogena u krvi (3 događaja, 0,8 %), krvarenje iz anastomoze (3 događaja, 0,8 %) i krvarenje nakon zahvata (2 događaja, 0,5 %).
English: ● Re-treatment may be required if there are folds, creases, or crimps in the EVARREST sealant matrix.
Croatian: Ponovno postavljanje može biti potrebno ako postoje nabori, uvrnuća ili uzdignuća u već postavljenom EVARREST matrica za tkivno ljepilo.
English: It is strongly recommended that every time EVARREST 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.
Croatian: Osobito se preporučuje da se svaki put kad se primjenjuje EVARREST, zabilježe naziv lijeka i broj serije kako bi se održala poveznica između bolesnika i serije lijeka.
English: Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure, and anaphylaxis (a severe reaction with a rapid onset).
Croatian: Znakovi takvih reakcija uključuju koprivnjaču, osip, stezanje u prsima, piskanje, pad krvnog tlaka i anafilaksiju (tešku reakciju s brzim nastupom).
English: Clinical studies demonstrating haemostasis in mild or moderate soft tissue bleeding were conducted in a total of 141 subjects (111 treated with EVARREST and 30 with control) undergoing abdominal, retroperitoneal, pelvic, and (non-cardiac) thoracic surgery.
Croatian: Klinička ispitivanja koja potvrđuju hemostazu kod blagog ili umjerenog krvarenja mekih tkiva provedena su na ukupno 141 ispitanika (u 111 je bila primijenjena matrica EVARREST u 30 kontrolni postupak), a koji su podvrgnuti abdominalnom, retroperitonealnom, pelvičnom i (ne kardijalnom) torakalnom kirurškom zahvatu.
English: Standard of Care was manual compression (MC) with or without a topical absorbable haemostat (TAH) or any other adjunctive haemostasis technique that was deemed by the surgeon to be his/her standard of care.
Croatian: Topical absorbable haemostat, TAH) ili bilo kojom drugom pomoćnom tehnikom hemostaze za koju je kirurg procijenio da je njegov/njezin standardni postupak.
English: The tray is in a sachet (polyester laminated aluminum foil) with a seal.
Croatian: Plitica je u zalijepljenoj vrećici (poliesterom laminirana aluminijska folija).
English: One (1/75) adverse reaction of deep vein thrombosis was reported in the EVARREST group.
Croatian: Jedna nuspojava (1/75) duboke venske tromboze prijavljena je u skupini s primijenjenim EVARREST-om.
English: EVARREST must not be used to repair injuries to the wall of large arteries or veins where the product is exposed to constant blood flow and pressure.
Croatian: EVARREST se ne smije primjenjivati za zatvaranje ozljeda stijenke velikih arterija ili vena gdje je pripravak izložen neprekidnom protoku krvi i tlaku.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: EVARREST is a white-to-yellow bio-absorbable combination product made from a flexible composite Matrix, coated with Human Fibrinogen and Human Thrombin.
Croatian: EVARREST je bijeli do žuti bioresorptivni kombinirani proizvod načinjen od kompozitne fleksibilne matrice obložene ljudskim fibrinogenom i ljudskim trombinom.
English: EVARREST is a combination product made from an absorbable material (Matrix) coated with human fibrinogen and human thrombin.
Croatian: EVARREST je kombinirani lijek načinjen od resorptivnog materijala (matriksa) obloženog ljudskim fibrinogenom i trombinom.
English: EVARREST was used to treat soft tissue bleeding during retroperitoneal, intra-abdominal, pelvic, or thoracic surgery, suture hole bleeding during cardiovascular surgery, and parenchymal bleeding during hepatic or renal surgery across all clinical trials involving 381 subjects treated with EVARREST and 272 control subjects.
Croatian: EVARREST se koristio za zaustavljanje krvarenja iz mekih tkiva tijekom retroperitonealnih kirurških zhvata, intraabdominalnih zahvata, zahvata unutar zdjelice i torakalnih kirurškh zahvata, za zaustavljanje krvarenja iz ubodnih rana šava pri kardiovaskularnim kirurškim zahvatima i kod parenhimalnog krvarenja tijekom kirurških zahvata na jetri i bubrezima u kliničkim ispitivanjima koja su obuhvaćala 381 ispitanika s primijenjenim EVARREST-om i 272 kontrolna ispitanika.
English: Two clinical studies in 206 patients undergoing hepatic surgery (110 treated with EVARREST and 96 with control) demonstrated haemostatic efficacy in persistent parenchymal bleeding.
Croatian: Dva klinička ispitivanje na 206 bolesnika koji su podvrgnuti kirurškom zahvatu na jetri (u 110 je primijenjena matrica EVARREST a 96 kontrolni postupak) pokazalo je hemostatsku djelotvornost kod perzistirajućeg parenhimskog krvarenja.
English: 5b) To ensure haemostasis, immediately apply manual compression over the entire surface of EVARREST (including the area of overlap) sufficient to stem all bleeding.
Croatian: 5b) Da biste osigurali hemostazu odmah primijenite manualnu kompresiju preko cijele površine lijeka EVARREST (uključujući područje preklapanja) dostatnu da se cjelokupno krvarenje prekine.
English: A prospective randomised controlled clinical study was conducted enrolling 156 subjects (76 EVARREST, 80 haemostatic fleece) demonstrating the safety and haemostatic effectiveness of EVARREST as an adjunct to controlling bleeding during cardiovascular surgery.
Croatian: Provedeno je prospektivno, randomizirano kontrolirano kliničko ispitivanje koje je uključivalo 156 ispitanika (76 s primjenom EVARREST-a, 80 s primjenom hemostatske spužvice) koje je pokazalo sigurnost i hemostatsku djelotvornost EVARREST-a kao pomoćnog sredstva u kontroli krvarenja tijekom kardiovaskularnog kirurškog zahvata.
English: The quantity of EVARREST to be applied depends upon the area and location of the bleeding area to be treated.
Croatian: Količina lijeka EVARREST koju treba nanijeti ovisi o području i mjestu krvarenja na koje će se primijeniti.
English: ● Intra-abdominal haemorrhage Localised intra-abdominal fluid collection
Croatian: Lokalizirano intraabdominalno nakupljanje
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se odnosi također na nepoznate viruse ili na viruse u nastajanju te druge patogene.
English: Apply the active side of EVARREST to the bleeding area, allowing full contact with the tissue.
Croatian: Primijenite djelatnu stranu lijeka EVARREST na područje krvarenja tako da bude u punom kontaktu s tkivom.
English: For epilesional use only.
Croatian: Samo za epilezijsku uporabu.
English: Gently remove surgical gauze or laparotomy pads from the application site, without disrupting or dislodging EVARREST or the clot.
Croatian: Lagano skinite kiruršku gazu ili laparotomijske jastučiće s mjesta primjene bez pomicanja ili odvajanja pripravka EVARREST ili ugruška.
English: NAME OF THE MEDICINAL PRODUCT EVARREST Sealant Matrix EVARREST contains per cm2
Croatian: EVARREST matrica za tkivno ljepilo EVARREST sadrži po cm2
English: As with any implantable product, foreign body reactions may occur.
Croatian: Kao sa svakim lijekom za implantaciju, mogu nastati reakcije na strano tijelo.
English: If no other primary haemostatic measures (i.e., standard surgical techniques) appear to be required, repeat the application procedure above with a new EVARREST sealant matrix.
Croatian: Ako se čini da nisu potrebne druge primarne hemostatske mjere (tj. standardne kirurške tehnike), ponovite prethodno opisani postupak primjene s novim matriksom za tkivno ljepilo EVARREST.
English: The non-active side has an embossed wave pattern.
Croatian: Nedjelatna strana ima otisnut valoviti uzorak.
English: If bleeding still occurs, the EVARREST sealant matrix can be removed, and a new one can be applied.
Croatian: Ako je krvarenje i dalje prisutno, EVARREST matrica za tkivno ljepilo se može ukloniti i staviti novi.
English: Data from eight clinical trials with EVARREST have been pooled into an integrated dataset and the frequencies of occurrence described in the table below originate from this integrated dataset.
Croatian: Podaci iz osam kliničkih ispitivanja EVARREST-a objedinjena sui u integrirani niz podataka iz kojeg potječu podaci o učestalosti pojavljivanja određenih nuspojava navedene u tablici u nastavku.
English: ● EVARREST must not be used in closed spaces (e.g., in, around, or in proximity to foramina in bone or areas of bony confine) since swelling may cause nerve or blood vessel compression.
Croatian: ● EVARREST se ne smije koristiti u zatvorenim prostorima (primjerice, u, oko ili u blizini koštanih otvora ili područja koje je omeđeno kosti) jer oticanje matrica može uzrokovati kompresiju živca ili krvne žile.
English: Your surgeon must not treat you with EVARREST in the following circumstances: EVARREST must not be applied inside blood vessels.
Croatian: Vaš kirurg ne smije Vam primijeniti EVARREST u sljedećim okolnostima:
English: NAME OF THE MARKETING AUTHORISATION HOLDER Omrix Biopharmaceuticals N.V.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Omrix Biopharmaceuticals N.V.
English: ● If bleeding still occurs during or after the specified duration of compression, remove the used EVARREST sealant matrix and inspect the bleeding site.
Croatian: • Ako se krvarenje i dalje nastavi tijekom ili nakon navedenog trajanja kompresije, uklonite iskorištenu EVARREST matricu za tkivno ljepilo i pregledajte mjesto krvarenja.
English: ● If bleeding is due to insufficient coverage of the bleeding area, additional EVARREST sealant matrices may be applied.
Croatian: • Ako je krvarenje nastalo zbog nedostatne pokrivenosti područja krvarenja, mogu se primijeniti dodatne matrice za tkivno ljepilo EVARREST.
English: Excipient(s) with known effect: Contains up to 3.0 mmol (68.8 mg) sodium per sealant matrix.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: Sadrži do 3,0 mmol (68,8 mg) natrija po matrica za tkivno ljepilo.
English: Human Fibrinogen:
Croatian: Izrael ljudski fibrinogen:
English: This medicine contains up to 3.0 mmol (68.8 mg) sodium in each EVARREST sealant matrix.
Croatian: Ovaj lijek sadrži do 3,0 mmol (68,8 mg) natrija po svakom matriksu za tkivno ljepilo EVARREST.
English: A further trial in 91 patients undergoing abdominal, retroperitoneal, pelvic, and (non-cardiac) thoracic surgery (59 treated with EVARREST and 32 with control) demonstrated haemostasis in severe soft tissue bleeding.
Croatian: Daljnje ispitivanje s 91 bolesnikom koji su podvrgnuti abdominalnom, retroperitonealnom, pelvičnom i (nekardijalnom) torakalnom kirurškom zahvatu (u 59 njih je primijenjena matrica EVARREST, a u 32 kontrolni postupak) imalo je učinkovitu hemostazu kod teškog krvarenja mekih tkiva.
English: The composite Matrix is composed of polyglactin 910 and oxidized regenerated cellulose, a commonly used haemostat.
Croatian: Kompozitna matrica sastavljena od poliglaktina 910 i oksidirane regenerirane celuloze često je korišteno sredstvo za hemostazu.
English: A post-marketing safety study enrolling 150 subjects was conducted using EVARREST.
Croatian: Kliničko ispitivanje sigurnosti primjene nakon stavljanja lijeka na tržište koje je uključivalo 150 ispitanika u kojih je primijenjen EVARREST.
English: Once the foil sachet is opened, EVARREST can remain in the sterile field to be available for use throughout the procedure.
Croatian: Nakon otvaranja folijske vrećice, matrica EVARREST može ostati u sterilnom polju kako bi bio dostupan za uporabu tijekom postupka.
English: EVARREST contains up to 3.0 mmol (68.8 mg) sodium per sealant matrix.
Croatian: EVARREST sadrži do 3,0 mmol (68,8 mg) natrija po matriksu za tkivno ljepilo.
English: Carton (10.2 cm x 10.2 cm, 5.1 cm x 10.2 cm) and Foil Sachet (10.2 cm x 10.2 cm)
Croatian: Kutija (10,2 cm x 10,2 cm, 5,1 cm x 10,2 cm) i folijska vrećica (10,2 cm x 10,2 cm)
English: EVARREST contains sodium
Croatian: EVARREST sadrži natrij
English: The active side is powdery in appearance.
Croatian: Djelatna strana ima praškast izgled.
English: Bleeding areas larger than those which can be covered by a single unit of EVARREST have not been investigated in clinical studies.
Croatian: U kliničkim ispitivanjima nisu istraživana područja krvarenja veća od onih koja se mogu pokriti jednim pripravkom EVARREST.
English: To open the product, remove the foil sachet from the carton, carefully peel open the foil sachet avoiding contact with the inside of the foil or the white sterile tray containing EVARREST.
Croatian: Za otvaranje proizvoda izvadite folijsku vrećicu iz kutije, pažljivo je odlijepite vodeći računa da izbjegnete kontakt s unutarnjom stranom folije ili bijelom, sterilnom pliticom koja sadrži EVARREST.
English: It is left in place after the operation and is absorbed by the body.
Croatian: Ostavlja se u tijelu nakon kirurškog zahvata te ga tijelo apsorbira.
English: If you get any side effects, talk to your doctor or surgeon.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti svog liječnika ili kirurga.
English: The use of more than four 10.2 cm x 10.2 cm units or eight 5.1 cm x 10.2 cm units, or the use in patients that have been previously exposed to EVARREST, has not been studied.
Croatian: Primjena više od četiri jedinice dimenzija 10,2 cm x 10,2 cm ili četiri jedinice dimenzija 5,1 cm x 10,2 cm, ili primjena u bolesnika kod kojih je ranije bila primijenjena matrica EVARREST nije ispitana.
English: The total amount of EVARREST left in the body after the operation should not exceed the size of two 10.2 cm x 10.2 cm sealant matrices or four 5.1 cm x 10.2 cm sealant matrices.
Croatian: Ukupna količina lijeka EVARREST preostala u tijelu nakon kirurškog zahvata ne smije premašiti veličinu dva matriksa za tkivno ljepilo dimenzija 10,2 cm x 10,2 cm cm ili četiri matriksa dimenzija 5,1 cm x 10,2 cm.