FrancophonIA/ELRC3.0 huggingface dataset:
English: The rate of hemostasis at the target bleeding site by 4 minutes was 92.8% in the VeraSeal treatment group and was 80.5% in the control group.
Croatian: Brzina hemostaze na ciljnom mjestu krvarenja za 4 minute bila je 92,8% u skupini liječenoj VeraSealom, a 80,5% u kontrolnoj skupini.
English: The rate of hemostasis at the target bleeding site by 4 minutes was 76.1% in the VeraSeal treatment group and was 22.8% in the control group.
Croatian: Brzina hemostaze na ciljnom mjestu krvarenja za 4 minute bila je 76,1% u skupini liječenoj VeraSealom, a 22,8% u kontrolnoj skupini.
English: Uncommon (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba):
English: Component 2: Thrombin 500 IU/ml
Croatian: Komponenta 2: trombin 500 IU/ml Epilezijski
English: - VeraSeal 2 ml (containing 1 ml of human fibrinogen and 1 ml of human thrombin) - VeraSeal 4 ml (containing 2 ml of human fibrinogen and 2 ml of human thrombin) - VeraSeal 6 ml (containing 3 ml of human fibrinogen and 3 ml of human thrombin) - VeraSeal 10 ml (containing 5 ml of human fibrinogen and 5 ml of human thrombin)
Croatian: - VeraSeal 2 ml (sadrži 1 ml ljudskog fibrinogena i 1 ml ljudskog trombina) - VeraSeal 4 ml (sadrži 2 ml ljudskog fibrinogena i 2 ml ljudskog trombina) - VeraSeal 6 ml (sadrži 3 ml ljudskog fibrinogena i 3 ml ljudskog trombina) - VeraSeal 10 ml (sadrži 5 ml ljudskog fibrinogena i 5 ml ljudskog trombina)
English: See Figure 8.
Croatian: Pogledajte sliku 8.
English: Two pre-filled syringes assembled in a syringe holder.
Croatian: Dvije napunjene štrcaljke na zajedničkom držaču štrcaljki.
English: Atrial fibrillation, ventricular tachycardia
Croatian: Srčani poremećaji fibrilacija atrija, ventrikularna tahikardija manje često
English: NAME OF THE MEDICINAL PRODUCT VeraSeal solutions for sealant human fibrinogen / human thrombin
Croatian: NAZIV LIJEKA VeraSeal otopine za tkivno ljepilo ljudski fibrinogen / ljudski trombin
English: During soft tissue surgery study 327 subjects were enrolled and underwent pelvic and retroperitoneal surgical procedures, and abdominoplasties and mastopexies.
Croatian: U ispitivanje kirurških zahvata na mekom tkivu bilo je uključeno 327 ispitanika koji su podvrgnuti kirurškim zahvatima u zdjelici i retroperitonealno, postupcima abdominoplastike i mastopeksije.
English: Thaw blister with VeraSeal pre-filled syringes at room temperature using the following steps:
Croatian: Blister pakiranje s VeraSeal napunjenim štrcaljkama odmrznite na sobnoj temperaturi pridržavajući se ovih koraka:
English: The rate of hemostasis at the target bleeding site by 4 minutes was 82.8% in the VeraSeal treatment group and was 77.8% in the control group.
Croatian: Brzina hemostaze na ciljnom mjestu krvarenja za 4 minute bila je 82,8% u skupini liječenoj VeraSealom, a 77,8% u kontrolnoj skupini.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Unatoč tomu, kada se primjenjuju lijekovi dobiveni iz ljudske krvi ili plazme, ne može se potpuno isključiti mogućnost prijenosa infektivnih uzročnika.
English: Grasp and bend the drip tip to the desired position.
Croatian: Uhvatite i savinite nastavak za primjenu kapanjem do željenog položaja.
English: Randomized, single-blind clinical studies with VeraSeal were conducted in subjects undergoing vascular, parenchymous tissue and soft tissue surgery demonstrating haemostasis, and suture support in vascular surgery.
Croatian: Randomizirana, jednostruko slijepa klinička ispitivanja provedena s VeraSealom u ispitanika podvrgnutih kirurškim postupcima koji su uključivali vaskularno, parenhimalno tkivo te meko tkivo, dokazala su hemostazu i potporu šavovima u vaskularnoj kirurgiji.
English: Open the blister and make the VeraSeal Dual Applicator and two additional Airless Spray Tips available to a second person for transfer to the sterile field.
Croatian: Otvorite blister pakiranje tako da omogućite drugoj osobi da VeraSeal dvojni aplikator i dva dodatna bezračna nastavka za raspršivanje prenese u sterilno polje.
English: Apply VeraSeal using the syringe holder and plunger supplied.
Croatian: VeraSeal primijenite pomoću isporučenog držača štrcaljki i klipa.
English: Keep the sterilized blister in the outer carton to protect from light.
Croatian: Sterilizirano blister pakiranje čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: For spray application, see sections 4.4 and 6.6 for specific recommendations on the required distance from tissue per surgical procedure.
Croatian: Za primjenu pomoću raspršivača i specifične preporuke o potrebnoj udaljenosti od tkiva prema vrsti kirurškog postupka, vidjeti dijelove 4.4 i 6.6.
English: It is supplied as a single-use kit containing two pre-filled syringes assembled in a syringe holder.
Croatian: Isporučuje se kao komplet za jednokratnu primjenu koji sadrži dvije napunjene štrcaljke na zajedničkom držaču.
English: Intravascular administration is contraindicated.
Croatian: Intravaskularna primjena je kontraindicirana.
English: The Airless Spray Tips are radiopaque.
Croatian: Bezračni nastavci za raspršivanje rendgenski su vidljivi.
English: - Very common (≥1/10) - common (≥1/100 to <1/10) - uncommon (≥1/1,000 to <1/100) - rare (≥1/10,000 to <1/1,000)
Croatian: rijetko (≥ 1/10 000 i <1/1000)
English: Once the blisters are opened, use VeraSeal immediately and discard any unused contents.
Croatian: Čim se blister pakiranja otvore VeraSeal treba upotrijebiti odmah, a neupotrijebljeni sadržaj baciti.
English: VeraSeal solutions for sealant human fibrinogen/human thrombin
Croatian: VeraSeal otopine za tkivno ljepilo ljudski fibrinogen / ljudski trombin
English: NOTE: Do not continue pushing the plunger in an attempt to clear the fibrin clot within the Airless Spray Tip; otherwise the applicator may become unusable.
Croatian: Ako se u bezračnom nastavku za raspršivanje nalazi fibrinski ugrušak, nemojte ga pokušati istisnuti daljnjim potiskivanjem klipa; aplikator bi inače mogao postati neupotrebljiv.
English: Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.8).
Croatian: Ako se pripravak nehotice primijeni intravaskularno, mogu se dogoditi po život opasne tromboembolijske komplikacije (vidjeti dio 4.8).
English: VeraSeal was shown to be superior to the control group (manual compression) in achieving hemostasis by 4 minutes.
Croatian: VeraSeal se pokazao superiornijim u odnosu na kontrolnu skupinu (manualna kompresija) u postizanju hemostaze za 4 minute.
English: VeraSeal must not be applied inside blood vessels.
Croatian: VeraSeal se ne smije primijeniti u krvnu žilu.
English: Once thawed, do not refreeze.
Croatian: Nakon odmrzavanja nemojte ponovno zamrzavati.
English: Once the blister is opened, VeraSeal should be used immediately.
Croatian: Kad se blister pakiranje otvori, VeraSeal treba primijeniti odmah.
English: If you get any side effects, talk to your doctor or surgeon.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili kirurga.
English: In use shelf life: Once the blister is opened, VeraSeal should be used immediately.
Croatian: Rok valjanosti u primjeni: kad se otvori blister pakiranje, VeraSeal treba upotrijebiti odmah.
English: • Room temperature thawing (preferred method)
Croatian: • Odmrzavanje na sobnoj temperaturi (poželjan način)
English: Figure 8
Croatian: Slika 8
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON [2 ml, 4 ml, 6 ml and 10 ml]
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA [2 ml, 4 ml, 6 ml i 10 ml]
English: VeraSeal was shown to be non-inferior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes.
Croatian: Pokazalo se da VeraSeal nije inferioran u odnosu na kontrolnu skupinu (oksidirana regenerirana celuloza) u postizanju hemostaze za 4 minute.
English: Store and transport in a freezer (at - 18 ºC or colder).
Croatian: Čuvati i prevoziti zamrznuto (na -18 ºC ili nižoj temperaturi).
English: Hyperglycaemia, hyperkalaemia, hypocalcaemia, hypoglycaemia, hypokalaemia, hypomagnesemia, hyponatraemia, hypoproteinaemia
Croatian: Poremećaji metabolizma i prehrane hiperglikemija, hiperkalijemija, hipokalcijemija, hipoglikemija, hipokalijemija, hipomagnezemija, hiponatrijemija, hipoproteinemija manje često
English: It must not be used if the solutions are cloudy or have deposits.
Croatian: Lijek se ne smije primijeniti ako su otopine zamućene ili sadrže talog.
English: Frozen solutions.
Croatian: Zamrznute otopine.
English: For epilesional use.
Croatian: Za epilezijsku primjenu.
English: VeraSeal was shown to be superior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes.
Croatian: VeraSeal se pokazao superiornijim u odnosu na kontrolnu skupinu (oksidirana regenerirana celuloza) u postizanju hemostaze za 4 minute.
English: The surgeon will apply VeraSeal to the surface of blood vessels or to the tissue surface of internal organs using an application device during the course of the operation.
Croatian: Za vrijeme operacije kirurg će pomoću aplikatora nanijeti VeraSeal na površinu krvnih žila ili na površinu unutarnjih organa.
English: NOTE: Red indicator will not be visible if Airless Spray Tip is properly connected.
Croatian: Ako je bezračni nastavak za raspršivanje pravilno spojen, crveni indikator neće biti vidljiv.
English: The instructions for use are also described in the healthcare professionals' package leaflet part.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Upute za upotrebu opisane su i u dijelu namijenjenom zdravstvenim radnicima u sklopu upute o lijeku.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Croatian: Rijetko se mogu razviti protutijela na komponente fibrinskog tkivnog ljepila/hemostatika.
English: During parenchymous tissue surgery study 325 subjects were enrolled and underwent liver resections.
Croatian: U ispitivanje kirurških zahvata na parenhimalnom tkivu bilo je uključeno 325 ispitanika koji su podvrgnuti resekciji jetre.
English: Application of the product must be individualised by the treating physician.
Croatian: Nadležni liječnik mora primjenu lijeka prilagoditi svakom bolesniku pojedinačno.
English: Deep vein thrombosis, hypertension, hypotension
Croatian: Krvožilni poremećaji duboka venska tromboza, hipertenzija, hipotenzija manje često
English: Tighten luer locks and ensure the Dual Applicator is firmly attached.
Croatian: Zategnite luer lock i provjerite je li dvojni aplikator čvrsto spojen.
English: Anaemia, haemorrhagic anaemia, leukocytosis, leukopenia
Croatian: Poremećaji krvi i limfnog sustava anemija, hemoragijska anemija, leukocitoza, leukopenija manje često
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL - HUMAN FIBRINOGEN (1 ml, 2 ml, 3 ml and 5 ml)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA ŠTRCALJKI - LJUDSKI FIBRINOGEN (1 ml, 2 ml, 3 ml i 5 ml)
English: Component 1: Fibrinogen 80 mg/ml
Croatian: Komponenta 1: fibrinogen 80 mg/ml Epilezijski
English: Abdominal abscess, cellulitis, liver abscess, peritonitis, postoperative wound infection, wound infection incision site infection, post procedural infection.
Croatian: Infekcije i infestacije abdominalni apsces, celulitis, apsces jetre, peritonitis, infekcija rane poslije operacije, infekcija rane, infekcija mjesta incizije, postproceduralna infekcija manje često
English: See Figure 5.
Croatian: Pogledajte sliku 5.
English: Hold the syringe holder with the luers pointed upward.
Croatian: Držač štrcaljki držite tako da su luer spojnice okrenute prema gore.
English: NAME OF THE MEDICINAL PRODUCT VeraSeal solutions for sealant
Croatian: NAZIV LIJEKA VeraSeal otopine za tkivno ljepilo
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL - HUMAN THROMBIN (1 ml, 2 ml, 3 ml and 5 ml)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA ŠTRCALJKI - LJUDSKI TROMBIN (1 ml, 2 ml, 3 ml i 5 ml)
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, piskavo disanje, hipotenziju i anafilaksiju.
English: Do not use solutions that are cloudy or have deposits.
Croatian: Nemojte upotrijebiti otopinu koja je zamućena ili sadrži talog.
English: To change the Airless Spray Tip, remove the device from the patient and unscrew the used Airless Spray Tip.
Croatian: Da biste to učinili, odmaknite uređaj od bolesnika i odvrnite upotrijebljeni nastavak.
English: VeraSeal should be applied as a thin layer.
Croatian: VeraSeal treba primijeniti u tankom sloju.
English: - Anaemia (insufficiency of red blood cells) - Anxiety - Atrial fibrillation (irregular heartbeat) - Back pain - Bladder spasm - Chills
Croatian: - anemija (nedovoljan broj crvenih krvnih stanica) - tjeskoba - treperenje srčanih pretklijetki (nepravilni srčani otkucaji) - bol u leđima - grč mokraćnog mjehura - zimica - nadraženost spojnice oka (nadraženost oka)
English: Unscrew and discard the syringe luer cap of both fibrinogen and thrombin syringes.
Croatian: Odvrnite i bacite luer kapice sa štrcaljke s fibrinogenom i štrcaljke s trombinom.
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
English: After thawing, it can be maintained not more than 48 hours at 2ºC - 8ºC or 24 hours at room temperature (20ºC - 25ºC) before use if it remains sealed in the original packaging.
Croatian: Poslije odmrzavanja a prije upotrebe, lijek se može držati najviše 48 sati na 2 ºC - 8 ºC ili 24 sata na sobnoj temperaturi (20 ºC - 25 ºC) ako ostane u neotvorenom, nepropusno zatvorenom originalnom pakiranju.
English: Hold the VeraSeal syringe holder with syringe luer caps pointed upward.
Croatian: VeraSeal držač štrcaljki uhvatite tako da su luer kapice štrcaljki okrenute prema gore.
English: After thawing, the kit containing the VeraSeal syringe holder with pre-filled syringes and Dual Applicator can be stored before use for not more than 48 hours in the refrigerator at 2 - 8 ºC or 24 hours at room temperature (20 - 25 °C) if it remains sealed in the original packaging.
Croatian: Ako je nakon odmrzavanja komplet koji sadrži VeraSeal držač štrcaljki s napunjenim štrcaljkama i dvojni aplikator ostao u neotvorenom originalnom pakiranju, može se čuvati do 48 sati u hladnjaku na temperaturi 2 - 8 ºC ili 24 sata na sobnoj temperaturi (20 - 25 ºC).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VeraSeal solutions for sealant
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
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 sealant/haemostatic products.
Croatian: U bolesnika liječenih fibrinskim tkivnim ljepilima/hemostaticima, u rijetkim se slučajevima mogu javiti reakcije preosjetljivosti ili alergijske reakcije (koje mogu uključivati angioedem, žarenje ili bockanje na mjestu primjene, bronhospazam, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskavo disanje).
English: After thawing, the solutions are clear or slightly opalescent and colourless or pale yellow.
Croatian: Poslije odmrzavanja otopine su bistre ili lagano opalescentne i bezbojne ili blijedo žute.
English: After thawing, it can be maintained not more than 48 hours at 2 ºC - 8 ºC or 24 hours at room temperature (20 ºC - 25 ºC) before use.
Croatian: Poslije odmrzavanja a prije upotrebe, lijek se može držati najviše 48 sati na 2 ºC - 8 ºC ili 24 sata na sobnoj temperaturi (20 ºC - 25 ºC).
English: Open the blister and make the VeraSeal syringe holder with pre-filled syringes available to a second person for transfer to the sterile field.
Croatian: Otvorite blister pakiranje tako da omogućite drugoj osobi da VeraSeal držač štrcaljki s napunjenim štrcaljkama prenese u sterilno polje.
English: The other ingredients are: - Component 1: Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid monosodium, water for injections.
Croatian: Drugi sastojci su: - komponenta 1: natrijev citrat dihidrat, natrijev klorid, arginin, izoleucin, natrijev glutamat, voda za injekcije - komponenta 2: kalcijev klorid, ljudski albumin, natrijev klorid, glicin, voda za injekcije.
English: For epilesional use only.
Croatian: Samo za epilezijsku primjenu.
English: See Figure 1.
Croatian: Pogledajte sliku 1.
English: Abdominal wound dehiscence, post procedural bile leak, contusion, incision site erythema, incision site pain, post procedural haemorrhage, procedural hypotension, vascular graft complication, vascular graft thrombosis, wound secretion
Croatian: Ozljede, trovanja i proceduralne komplikacije bol tijekom postupka često dehiscencija abdominalne rane, postproceduralno curenje žuči, kontuzija, eritem na mjestu incizije, bol na mjestu incizije, postproceduralna hemoragija, proceduralna hipotenzija, komplikacija vaskularnog presatka, tromboza vaskularnog presatka, iscjedak iz rane manje često
English: Human fibrinogen 80 mg/ml Component 2:
Croatian: ljudski fibrinogen 80 mg/ml
English: Life threatening thromboembolic complications may occur if the preparation is unintentionally applied intravascularly.
Croatian: Ako se pripravak nehotice primijeni intravaskularno, mogu se dogoditi po život opasne tromboembolijske komplikacije.
English: How VeraSeal is used
Croatian: Kako primjenjivati VeraSeal
English: Transferring instructions
Croatian: Upute za postupak prijenosa
English: Place the blister containing the syringe holder with pre-filled syringes on a surface at room temperature (20 ºC - 25 ºC) for approximately 70 minutes for the 2 ml and the 4 ml package sizes for approximately 90 minutes for the 6 ml and the 10 ml package sizes
Croatian: pakiranja od 2 ml i 4 ml tijekom približno 70 minuta pakiranja od 6 ml i 10 ml tijekom približno 90 minuta.
English: Calcium chloride Human albumin Sodium chloride Glycine
Croatian: kalcijev klorid ljudski albumin natrijev klorid glicin voda za injekcije
English: Frequency of Adverse Reactions (ADRs) in clinical studies with VeraSeal:
Croatian: Učestalosti nuspojava u kliničkim ispitivanjima s VeraSealom:
English: • Disposal
Croatian: • Zbrinjavanje
English: Dry the syringe holder with pre-filled syringes after thawing, using a sterile surgical gauze.
Croatian: Poslije odmrzavanja držač štrcaljki s napunjenim štrcaljkama obrišite sterilnom kirurškom gazom.
English: It must be stored in a freezer at -18 ºC or colder.
Croatian: Čuvati u zamrzivaču (na -18 ºC ili nižoj temperaturi).
English: • Connection instructions
Croatian: • Upute za spajanje aplikatora
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava preosjetljivost*
English: Supportive treatment in adults where standard surgical techniques are insufficient:
Croatian: Potporno liječenje u odraslih kada standardne kirurške tehnike nisu dovoljne: - za poboljšanje hemostaze - kao potpora šavovima u vaskularnoj kirurgiji.
English: Pruritus
Croatian: Nuspojava
English: - if you are allergic to human fibrinogen or human thrombin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Kirurg Vam ne smije primijeniti VeraSeal - ako ste alergični na ljudski fibrinogen ili ljudski trombin ili neki drugi sastojak ovog lijeka
English: Excipients: human fibrinogen - Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid monosodium, water for injections.
Croatian: Pomoćne tvari: ljudski fibrinogen - natrijev citrat dihidrat, natrijev klorid, arginin, izoleucin, natrijev glutamat, voda za injekcije. ljudski trombin - kalcijev klorid, ljudski albumin, natrijev klorid, glicin, voda za injekcije.
English: Water for injections
Croatian: - infekcija rane
English: See Figure 2.
Croatian: Pogledajte sliku 2.
English: Solutions for sealant
Croatian: Rukovanje VeraSealom
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER LABEL [2 ml, 4 ml, 6 ml and 10 ml]
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA BLISTERU [2 ml, 4 ml, 6 ml i 10 ml]
English: Constipation, flatulence, ileus, retroperitoneal haematoma, vomiting
Croatian: Poremećaji probavnog sustava mučnina često konstipacija, flatulencija, ileus, retroperitonealni hematom, povraćanje manje često
English: How VeraSeal is stored
Croatian: Kako čuvati VeraSeal
English: After thawing, the solutions must be clear to slightly opalescent and colorless to pale yellow.
Croatian: Poslije odmrzavanja otopine moraju biti bistre ili lagano opalescentne i bezbojne do blijedo žute.
English: MedDRA System Organ Class (SOC)
Croatian: MedDRA - klasifikacija organskih sustava
English: Do not refreeze once thawed.
Croatian: Odmrznut lijek nemojte ponovno zamrzavati.
English: Plasma cell myeloma
Croatian: mijelom plazma stanica manje često
English: Place the used Airless Spray Tip away from the spare Airless Spray Tips.
Croatian: Iskorišteni bezračni nastavak za raspršivanje odložite podalje od rezervnih bezračnih nastavaka.
English: Sodium citrate dihydrated Sodium chloride Arginine
Croatian: natrijev citrat dihidrat natrijev klorid arginin izoleucin natrijev glutamat voda za injekcije Štrcaljka s ljudskim trombinom:
English: Skin and subcutaneous tissue disorders
Croatian: OBLIK I SADRŽAJ Otopine za tkivno ljepilo
English: See Figure 3.
Croatian: PRILOG III.
English: Apply firm even pressure to the plunger to spray the fibrin sealant.
Croatian: Čvrstim ujednačenim potiskivanjem klipa raspršite fibrinsko ljepilo.
English: One Dual Applicator with two additional Airless Spray Tips is supplied with the product, for application by spraying or dripping.
Croatian: Uz lijek se dobije dvojni aplikator za primjenu lijeka raspršivanjem ili kapanjem, i dva dodatna bezračna nastavka za raspršivanje.
English: Chills, hyperthermia, oedema peripheral, pain, pyrexia, vessel puncture site haematoma
Croatian: Opći poremećaji i reakcije na mjestu primjene zimica, hipertermija, periferni edem, bol, pireksija, hematom na mjestu uboda u žilu manje često
English: Psychiatric disorders
Croatian: Prenosivi uzročnici bolesti
English: Musculoskeletal and connective tissue disorders
Croatian: VeraSeal otopine za tkivno ljepilo
English: Pulmonary embolism, dyspnoea, hypoxia, pleural effusion, pleurisy, pulmonary oedema, rhonchi, wheezing
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja plućna embolija, dispneja, hipoksija, pleuralni izljev, pleuritis, plućni edem, hropci, piskavo disanje manje često
English: Component 1: 1 ml of human fibrinogen (80 mg/ml) Component 2: 1 ml of human thrombin (500 IU/ml)
Croatian: Komponenta 1: 1 ml ljudskog fibrinogena (80 mg/ml) Komponenta 2: 1 ml ljudskog trombina (500 IU/ml)
English: Component 1: 5 ml of human fibrinogen (80 mg/ml) Component 2: 5 ml of human thrombin (500 IU/ml)
Croatian: Komponenta 1: 5 ml ljudskog fibrinogena (80 mg/ml) Komponenta 2: 5 ml ljudskog trombina (500 IU/ml)
English: Component 1: 3 ml of human fibrinogen (80 mg/ml) Component 2: 3 ml of human thrombin (500 IU/ml)
Croatian: Komponenta 1: 3 ml ljudskog fibrinogena (80 mg/ml) Komponenta 2: 3 ml ljudskog trombina (500 IU/ml)
English: Isoleucine
Croatian: Sljedivost
English: Application by spraying
Croatian: Primjena raspršivanjem