FrancophonIA/ELRC3.0 huggingface dataset:
English: • It is not known whether radiation therapy could affect the effectiveness of fibrin sealant when used for suture line sealing during neurosurgery.
Croatian: • Nije poznato utječe li radioterapija na djelotvornost fibrinskog ljepila kada se primjenjuje za lijepljenje linije šava u neurokirurškim postupcima.
English: The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer.
Croatian: Lijek je potrebno raspršiti na površinu tkiva u kratkim štrcajima (0,1-0,2 ml) kako bi se formirao tanak, ujednačen sloj.
English: Component 2: Human thrombin 800-1200 IU/ml
Croatian: Komponenta 2: humani trombin 800-1200 IU/ml
English: If you get any side effects, talk to your doctor , pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
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).
Croatian: Manje česte nuspojave tijekom kliničkih ispitivanja lijeka EVICEL (mogu se pojaviti u 1 na 100 osoba), uključuju infekciju, nakupljanje krvi (hematome), oticanje, smanjenje koncentracije hemoglobina, te postoperativne komplikacije rane (uključujući krvarenje ili infekciju).
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.
Croatian: Djelotvornost lijeka EVICEL za lijepljenje linije šava kod zatvaranja dure mater dokazano je kod 139 bolesnika (u 89 je primijenjen EVICEL, a 50 je sačinjavalo kontrolnu skupinu) podvrgnutih postupcima kraniotomije/kranijektomije.
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.
Croatian: Ako razvijete alergijsku reakciju, možete imati jedan ili više od sljedećih simptoma: kožni osip, koprivnjaču, stezanje u prsnom košu, zimicu, navale crvenila, glavobolju, nizak krvni tlak, bezvoljnost, mučninu, osjećaj nemira, ubrzani puls, trnce, povraćanje ili piskanje pri disanju.
English: 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.
Croatian: Poduzete mjere smatraju se učinkovitima protiv virusa s lipidnom ovojnicom poput HIV-a, virusa hepatitisa C i virusa hepatitisa B, te protiv virusa hepatitisa
English: Omrix Pressure Regulator
Croatian: Regulator tlaka Omrix
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g., haemolytic anaemia).
Croatian: Infekcija parvovirusom B19 može biti opasna za trudnice (infekcija fetusa) te za osobe s imunodeficijencijom ili pojačanom eritropoezom (npr. hemolitičkom anemijom).
English: The measures taken in the manufacture of fibrinogen and thrombin are considered effective for lipid coated viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and the non-enveloped virus, hepatitis A. The measures taken may be of limited value against parvovirus B19.
Croatian: Mjere koje se poduzimaju u proizvodnji fibrinogena i trombina smatraju se učinkovitima protiv virusa s lipidnom ovojnicom, poput virusa humane imunodeficijencije (HIV), virusa hepatitisa B i hepatitisa C te za viruse bez ovojnice, poput virusa hepatitisa A.
English: Adverse reactions - neurosurgery
Croatian: Nuspojave - neurokirurgija
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 opasna za trudnice (infekcija ploda), za osobe s oslabljenim imunološkim sustavom ili osobe koje boluju od nekih vrsta anemije (npr. anemije srpastih stanica ili hemolitičke anemije).
English: Adverse reaction rates in retroperitoneal or intra-abdominal surgery study
Croatian: Stopa nuspojava u kliničkim ispitivanjima u retroperitonealnoj ili intraabdominalnoj kirurgiji
English: The use of EVICEL is restricted to experienced surgeons who have been trained in the use of EVICEL.
Croatian: EVICEL smiju koristiti samo iskusni kirurzi koji su obučeni u primjeni lijeka EVICEL.
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.
Croatian: Međutim, naručitelj ispitivanja je smatrao da su 3 ozbiljne nuspojave (jedan abdominalni apsces u skupini u kojoj je primijenjen EVICEL te jedan abdominalni apsces i jedan zdjelični apsces u kontrolnoj skupini) potencijalno povezane s primjenom ispitivanog lijeka.
English: Do not refrigerate EVICEL once it has reached room temperature.
Croatian: Nakon što je postigao sobnu temperaturu, EVICEL nemojte odlagati u hladnjak.
English: Before use, the product must reach 20°C-30°C.
Croatian: Prije primjene lijek mora dostići temperaturu od 20°C - 30°C.
English: Clinical studies demonstrating haemostasis and suture support were conducted in a total of 147 patients (75 with EVICEL, 72 with control) undergoing vascular surgery with PTFE grafts and in a total of 135 patients (66 with EVICEL, 69 with control) undergoing retroperitoneal and intra-abdominal surgery.
Croatian: Klinička ispitivanja u kojima je dokazano potporno djelovanje na hemostazu i šavove provedena su na ukupno 147 bolesnika (75 u kojih je primijenjen EVICEL te 72 u kontrolnoj skupini) podvrgnutih vaskularnom kirurškom zahvatu s ugradnjom PTFE presatka te na ukupno 135 bolesnika (66 u kojih je primijenjen EVICEL i 69 u kontrolnoj skupini) podvrgnutih retroperitonealnom odnosno intraabdominalnom kirurškom zahvatu.
English: EVICEL is also indicated in adults as suture support for haemostasis in vascular surgery and for suture line sealing in dura mater closure.
Croatian: EVICEL je također indiciran u odraslih kao potpora hemostatskim šavovima u kirurgiji krvnih žila te za lijepljenje linije šava dure mater prilikom njenog zatvaranja.
English: The active substances are as follows:
Croatian: Djelatne tvari navedene su u nastavku:
English: How to store EVICEL
Croatian: Kako primjenjivati EVICEL
English: EVICEL can be used in blood vessel surgery and in surgery taking place on the posterior abdominal wall.
Croatian: EVICEL se može koristiti u kirurgiji krvnih žila te u kirurškim zahvatima na stražnjoj trbušnoj stijenci.
English: These included intracranial hypotension (CSF leakage), CSF rhinorrhea, meningitis, headache, hydrocephalus, subdural hygroma, and haematoma.
Croatian: Nuspojave su uključivale intrakranijalnu hipotenziju (istjecanje likvora), rinoreju likvora, meningitis, glavobolju, hidrocefalus, subduralni higrom i hematome.
English: • sealing surgical repairs to the intestines
Croatian: • lijepljenja kod kirurških popravaka na crijevima.
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:
Croatian: Kada EVICEL primjenjujete raspršivačem, pazite da su upotrijebljeni tlak i udaljenost od tkiva unutar raspona koji preporučuje proizvođač raspršivača.
English: During your operation, your doctor will drip or spray EVICEL onto raw tissue, using an application device.
Croatian: Za vrijeme operacije liječnik će pomoću aplikatora nakapati ili raspršiti lijek EVICEL na otvoreno tkivo.
English: In a controlled study involving 139 patients undergoing elective neurosurgical procedures (89 treated with EVICEL and 50 controls), a total of 7 subjects treated with EVICEL experienced nine AEs that were considered to be possibly related to the study product.
Croatian: U kontroliranom ispitivanju koje je uključivalo 139 bolesnika podvrgnutih elektivnim neurokirurškim postupcima (u 89 bolesnika primijenjen je EVICEL, a 50 je činilo kontrolnu skupinu) ukupno je 7 ispitanika u kojih je primijenjen EVICEL iskusilo devet nuspojava za koje se smatra da bi mogle biti povezane s ispitivanim lijekom.
English: EVICEL is supplied as a package containing two separate vials (glass type I) with rubber stoppers (type I), each containing 1 ml, 2 ml, or 5 ml solution of Human Fibrinogen and Human Thrombin, respectively.
Croatian: EVICEL se isporučuje u pakiranju koje sadrži dvije odvojene bočice (staklo tipa I) s gumenim čepovima (tipa I), od kojih svaka sadrži 1 ml, 2 ml ili 5 ml otopine humanog fibrinogena odnosno humanog trombina.
English: 35 cm rigid tip 45 cm flexible tip
Croatian: kruti nastavak duljine 35 cm savitljivi nastavak duljine 45 cm
English: Do not re-freeze once thawed.
Croatian: Nakon odmrzavanja ne ponovno zamrzavati.
English: The vials must be stored in an upright position.
Croatian: Bočice se moraju čuvati u uspravnom položaju.
English: - Periodic Safety Update Reports
Croatian: • Periodička izvješća o neškodljivosti
English: 20 - 25 psi (1.4 - 1.7 bar)
Croatian: 10 - 15 cm20 - 25 psi (1,4 - 1,7 bar)
English: Store in a freezer at -18°C or colder.
Croatian: Čuvati u zamrzivaču na temperaturi od -18°C ili nižoj.
English: • EVICEL must not be used for sealing the suture line in dura mater if there are gaps of greater than 2 mm after suturing.
Croatian: • EVICEL se ne smije primjenjivati za lijepljenje linije šava dure mater ako nakon postavljenih šavova zaostane razmak između rubova širi od 2 mm.
English: EVICEL must not be used as a sealant when the dura mater cannot be sutured.
Croatian: EVICEL se ne smije koristiti kao ljepilo kad se dura mater ne može zašiti.
English: Store in a freezer at or below -18C.
Croatian: Čuvati u zamrzivaču na temperaturi od -18C ili nižoj.
English: EVICEL must not be used for sealing the suture line in dura mater if there are gaps of greater than 2 mm after suturing.
Croatian: EVICEL se ne smije primjenjivati za lijepljenje linije šava dure mater ako nakon šivanja zaostanu razmaci između rubova širi od 2 mm.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Croatian: Rijetko se mogu razviti protutijela na komponente tkivnog ljepila/hemostatskih lijekova.
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:
Croatian: • Edukacijski materijal za zdravstvene radnike obavijestit će o o riziku od po život opasne plinske embolije ako se lijek nepravilno raspršuje o isključivoj primjeni stlačenog CO2
English: Do not use this medicine after the expiry date which is stated on the label as well as on the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i pakiranju iza oznake „Rok valjanosti” / „EXP“.
English: Component 1: Human clottable protein 50 - 90 mg/ml
Croatian: Komponenta 1: Humani protein sa sposobnošću zgrušavanja 50-90 mg/ml
English: In a controlled study involving 147 patients undergoing vascular grafting procedures (75 treated with EVICEL and 72 controls), a total of 16 subjects were reported to have had a graft thrombosis/occlusion adverse event during the study period.
Croatian: U kontroliranom ispitivanju u koje je bilo uključeno 147 bolesnika podvrgnutih postupcima ugradnje krvožilnih presadaka (75 bolesnika u kojih je primijenjen EVICEL i 72 bolesnika iz kontrolne skupine) ukupno je u 16 ispitanika prijavljena nuspojava okluzije/tromboze presatka tijekom ispitivanja.
English: Adverse reactions in retroperitoneal or intra-abdominal surgery study Infections and infestations
Croatian: Nuspojave u ispitivanjima u retroperitonealnoj ili intraabdominalnoj kirurgiji Infekcije i infestacije abdominalni apsces često
English: 20°C-25°C (room temperature): vials thaw within 1 hour, or 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.
Croatian: Bočice je potrebno odmrznuti na jedan od sljedećih načina: na temperaturi od 2°C - 8°C (u hladnjaku): bočice će se odmrznuti za 1 dan, ili na temperaturi od 20°C - 25°C (sobna temperatura): bočice će se odmrznuti za 1 sat, ili na temperaturi od 37°C (npr. vodena kupelj, primjenom aseptične tehnike ili zagrijavanjem bočice u ruci): bočice je potrebno odmrznuti u roku od 10 minuta te ih se ne smije ostaviti na toj temperaturi dulje od 10 minuta ili dok se potpuno ne odmrznu.
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.
Croatian: Bočice je potrebno odmrznuti na jedan od sljedećih načina: na temperaturi od 2°C - 8°C (u hladnjaku): bočice će se odmrznuti za jedan dan, na temperaturi od 20°C - 25°C (sobna temperatura): bočice će se odmrznuti za jedan sat na temperaturi od 37°C (npr. vodena kupelj, primjenom aseptičke tehnike ili zagrijavanjem bočice u ruci): bočice je potrebno odmrznuti u roku od 10 minuta te ih se ne smije ostaviti na toj temperaturi dulje od 10 minuta ili dok se potpuno ne odmrznu.
English: Once drawn up into the application device, the product must be used immediately.
Croatian: Nakon što se navuče u aplikator, lijek se mora odmah primjeniti.
English: Within the 2 years shelf life, after thawing, unopened vials can be stored at 2C - 8C and protected from light, for up to 30 days.
Croatian: Unutar 2-godišnjeg roka valjanosti, nakon odmrzavanja, neotvorene bočice mogu se čuvati na temperaturi od 2°C - 8°C i zaštićene od svjetlosti najdulje 30 dana.
English: • EVICEL must not be used as a glue for the fixation of dural patches.
Croatian: • EVICEL se ne smije primjenjivati kao ljepilo za učvršćivanje duralnih zakrpa.
English: If these symptoms occur, the administration has to be discontinued immediately.
Croatian: Ako se pojave ti simptomi, odmah treba prekinuti davanje lijeka.
English: EVICEL Applicator Device
Croatian: Aplikator lijeka EVICEL
English: • EVICEL must not be applied intravascularly.
Croatian: • EVICEL se ne smije primjenjivati intravaskularno.
English: EVICEL is a Human Fibrin Sealant which is supplied as a package containing two separate vials, each containing 1 ml, 2 ml or 5 ml of solution (Human Fibrinogen and Human Thrombin respectively).
Croatian: EVICEL je humano fibrinsko tkivno ljepilo koje se isporučuje u kutiji s dvije odvojene bočice, od kojih svaka sadrži 1 ml, 2 ml ili 5 ml otopine (humanog fibrinogena odnosno humanog trombina).
English: • EVICEL must not be used as a sealant when the dura mater cannot be sutured.
Croatian: • EVICEL se ne smije primjenjivati kao tkivno ljepilo kada se dura mater ne može zašiti.
English: Signs of allergic reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure, and breathing difficulties.
Croatian: Znakovi alergijskih reakcija uključuju koprivnjaču, osip, stezanje u prsnom košu, piskanje pri disanju, pad krvnog tlaka i otežano disanje.
English: It must not be applied intravascularly.
Croatian: Ne smije se primijeniti intravaskularno.
English: Component 2: calcium chloride, human albumin, mannitol, sodium acetate, and water for injections.
Croatian: Komponenta 2: kalcijev klorid, humani albumin, manitol, natrijev acetat i voda za injekcije.
English: Do not use after the expiry date stated on the carton and label.
Croatian: Lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici.
English: Meningitis
Croatian: Omrix
English: EVICEL must not be used as a glue for the fixation of dural patches.
Croatian: EVICEL se ne smije primjenjivati kao ljepilo za učvršćivanje duralnih zakrpa.
English: EVICEL is a fibrin sealant.
Croatian: EVICEL je fibrinsko tkivno ljepilo.
English: Human Fibrinogen: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, water for injections.
Croatian: Humani fibrinogen: argininklorid, glicin, natrijev klorid, natrijev citrat, kalcijev klorid, voda za injekcije.
English: To avoid the risk of potentially life-threatening air or gas embolism EVICEL should be sprayed using pressurized CO2 gas only (see table below).
Croatian: Kako bi se izbjegao rizik od potencijalno po život opasne zračne ili plinske embolije, EVICEL se smije raspršivati samo pomoću stlačenog CO2 (vidjeti tablicu dolje).
English: By the end of this period the product has to be used or discarded.
Croatian: Lijek se treba primjeniti ili zbrinuti u otpad do kraja ovog razdoblja.
English: EVICEL is intended for epilesional use only.
Croatian: EVICEL je namijenjen samo za epilezijsku primjenu.
English: EVICEL must not be applied intravascularly.
Croatian: EVICEL se ne smije primijeniti intravaskularno.
English: The solutions should be clear or slightly opalescent.
Croatian: Otopine trebaju biti bistre ili blago opalescentne.
English: Component 1: arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, and water for injections.
Croatian: Komponenta 1: argininklorid, glicin, natrijev klorid, natrijev citrat, kalcijev klorid, voda za injekcije.
English: Human Thrombin: calcium chloride, human albumin, mannitol, sodium acetate, water for injections.
Croatian: Humani trombin: kalcijev klorid, humani albumin, manitol, natrijev acetat, voda za injekcije.
English: Applicator tips to be used
Croatian: Nastavci aplikatora koji se koriste
English: EVICEL solutions for sealant human fibrinogen:
Croatian: EVICEL otopine za tkivno ljepilo humani fibrinogen:
English: Leaflets giving detailed instructions for use of EVICEL in conjunction with the application device and optional accessory tips are provided with the package of the application device and of the accessory tips.
Croatian: U pakiranjima aplikatora i dodatnog pribora nalaze se detaljne upute za primjenu lijeka EVICEL pomoću aplikatora i dodatnog pribora po izboru.
English: Application of the product must be individualised by the treating physician.
Croatian: Nadležni liječnik mora prilagoditi primjenu lijeka u svakog pojedinog bolesnika.
English: The solutions are clear or slightly opalescent.
Croatian: Otopine su bistre ili blago opalescentne.
English: • Prior to applying EVICEL, the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Croatian: • Prije nanošenja lijeka EVICEL, površinu rane treba osušiti standardnim tehnikama (npr. uzastopnim prislanjanjem kompresa, tupferima ili napravama za sukciju).
English: Open surgery
Croatian: Otvoreni kirurški zahvat
English: Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and anaphylaxis.
Croatian: Znakovi takvih reakcija uključuju koprivnjaču, osip, stezanje u prsnom košu, piskanje pri disanju, pad krvnog tlaka i anafilaksiju.
English: EVICEL should only be applied using the CE-marked EVICEL application device and optional use of accessory tips to the device.
Croatian: EVICEL se primjenjuje isključivo pomoću aplikatora lijeka EVICEL koji ima oznaku CE, uz koji se po izboru mogu koristiti dodatni nastavci.
English: Prior to applying EVICEL the surface area of the wound needs to be dried by standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices).
Croatian: Prije primjene lijeka EVICEL površinu rane treba osušiti primjenom standardnih tehnika (npr. naizmjeničnom aplikacijom kompresa, jastučića vate, primjenom naprava za usisavanje).
English: 1 vial containing 5 ml of human clottable protein 1 vial containing 5 ml of human thrombin
Croatian: 1 bočica koja sadrži 5 ml humanog proteina sa sposobnošću zgrušavanja 1 bočica koja sadrži 5 ml humanog trombina
English: Clear or slightly opalescent solutions.
Croatian: Bistre ili blago opalescentne otopine.
English: 10 - 15 cm (4 - 6 in)
Croatian: 4 - 10 cm
English: Spray application of EVICEL should not be used in endoscopic procedures.
Croatian: EVICEL se ne smije primjenjivati kao sprej u endoskopskim postupcima.
English: EVICEL solutions for sealant human fibrinogen, human thrombin
Croatian: EVICEL otopine za tkivno ljepilo humani fibrinogen, humani trombin
English: Among 135 patients undergoing retroperitoneal and intra-abdominal surgery (67 patients treated with EVICEL and 68 controls), no adverse events were considered to be causally related to the study treatment according to the investigator assessments.
Croatian: Prema procjenama ispitivača, niti jedna od nuspojava prijavljenih u 135 ispitanika podvrgnutih retroperitonealnom ili intraabdominalnom kirurškom zahvatu (67 bolesnika u kojih je primijenjen EVICEL i 68 bolesnika u kontrolnoj skupini) nije se smatrala uzročno povezanom s ispitivanim lijekom.
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Znakovi reakcija preosjetljivosti uključuju koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje (pri disanju), hipotenziju i anafilaksiju.
English: Component 1: Human clottable protein containing mainly fibrinogen and fibronectin (50 - 90 mg/ml) Component 2: Human thrombin (800 - 1,200 IU/ml)
Croatian: Komponenta 1: Humani protein sa sposobnošću zgrušavanja koji sadrži većinom fibrinogen i fibronektin (50-90 mg/ml)
English: 1 vial containing 1 ml of human clottable protein 1 vial containing 1 ml of human thrombin
Croatian: 1 bočica koja sadrži 1 ml humanog proteina sa sposobnošću zgrušavanja 1 bočica koja sadrži 1 ml humanog trombina
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.
Croatian: Kada se s ovim lijekom koriste dodatni nastavci, potrebno je pažljivo se pridržavati uputa za uporabu i tamo preporučenih raspona tlaka i udaljenosti od površine tkiva.
English: Solutions for sealant.
Croatian: Čuvati u uspravnom položaju.
English: 1 vial containing 2 ml human clottable protein 1 vial containing 2 ml of human thrombin
Croatian: 1 bočica koja sadrži 2 ml humanog proteina sa sposobnošću zgrušavanja 1 bočica koja sadrži 2 ml humanog trombina
English: EVICEL solutions for sealant human thrombin:
Croatian: EVICEL otopine za tkivno ljepilo humani trombin:
English: EVICEL solutions for sealant human fibrinogen human thrombin
Croatian: EVICEL otopine za tkivno ljepilo humani fibrinogen humani trombin
English: Device assembly
Croatian: Sklapanje uređaja
English: - Numbness or pain in your extremities, change in skin colour (due to Graft Occlusion or Thrombosis) The frequency of this effect was uncommon (may affect up to 1 in 100 people).
Croatian: - utrnulost ili bol u udovima, promjena boje kože (uzrokovane okluzijom grafta ili trombozom)
English: When spraying EVICEL, changes in blood pressure, pulse, oxygen saturation, and end tidal CO2 should be monitored because of the possibility of occurrence of air or gas embolism.
Croatian: Kada se EVICEL raspršuje, moraju se pratiti promjene krvnog tlaka, pulsa, saturacije kisikom i CO2 na kraju izdaha zbog moguće pojave zračne ili plinske embolije.
English: * Total quantity of protein is 80 - 120 mg/ml
Croatian: *Ukupna količina proteina iznosi 80-120 mg/ml Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: Adverse reactions in neurosurgery study Infections and infestations
Croatian: Nuspojave u neurokirurškom ispitivanju Infekcije i infestacije meningitis često
English: Laparoscopic procedures
Croatian: Omrix Biopharmaceuticals
English: Spray pressure
Croatian: Tlak raspršivanja