FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those not prescribed.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koji Vam nisu propisani.
English: The exact content and format of the educational material and educational programme including communication media, distribution modalities, and any other aspects of the programme, shall be agreed with the National Competent Authority.
Croatian: Točan sadržaj i format edukacijskih materijala i program edukacije uključujući komunikacijski medij, način distribucije i sve druge aspekte programa moraju se dogovoriti s nacionalnim nadležnim tijelom.
English: If you feel unwell tell your doctor immediately, even if your symptoms are different from those just described.
Croatian: Ako se ne osjećate dobro, odmah o tome obavijestite svog liječnika, čak i ako su vaši simptomi različiti od gore opisanih.
English: At the Cmax, the plasma concentration represented only 1-2% of the applied dose.
Croatian: Pri Cmax je koncentracija u plazmi predstavljala samo 1-2% primijenjene doze.
English: What EVICEL is and what it is used for
Croatian: Što je EVICEL i za što se koristi
English: Thus, when the two components are mixed together they clot instantly.
Croatian: Stoga, kada se te dvije komponente pomiješaju, odmah stvaraju ugrušak.
English: Human Fibrinogen:
Croatian: Humani fibrinogen:
English: Date of first authorisation: 06 October 2008 Date of latest renewal: 06 October 2013
Croatian: Datum posljednje obnove: 06. listopada 2013.
English: Frequencies have been evaluated according to the following convention: 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); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalosti su procijenjene prema sljedećoj konvenciji: Vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1 000 i <1/100); rijetko (≥1/10 000 i <1/1 000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka, treba primijeniti standardne mjere za medicinsko liječenje šoka.
English: Do not re-freeze.
Croatian: Ne ponovno zamrzavati.
English: Other medicines and EVICEL
Croatian: Drugi lijekovi i Evicel
English: Component 2 Human thrombin
Croatian: Komponenta 2 Humani trombin
English: The fibrin adhesion system initiates the last phase of physiological blood coagulation.
Croatian: Sustav fibrinske adhezije pokreće posljednju fazu fiziološkog procesa zgrušavanja krvi.
English: Other ingredients are:
Croatian: Drugi sastojci su:
English: • The use of EVICEL has not been studied in the following procedures, and there is therefore no information to show that it would be effective in these procedures:
Croatian: • Primjena lijeka EVICEL nije ispitana u sljedećim postupcima te stoga nema podataka koji bi ukazivali na njegovu djelotvornost kod sljedećih postupaka:
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima.
English: The initial volume of the product to be applied at a chosen anatomic site or target surface area should be sufficient to entirely cover the intended application area.
Croatian: Početni volumen lijeka koji će se primijeniti na odabranom anatomskom mjestu ili ciljnoj površini treba biti dostatan za potpuno prekrivanje željenog područja.
English: If you experience any of the above mentioned symptoms, or any other symptoms related to your surgery, please contact your doctor or surgeon immediately.
Croatian: Primijetite li bilo koji od gore navedenih simptoma, ili bilo koje druge simptome vezane za Vaš kirurški zahvat, odmah se obratite svom liječniku ili kirurgu.
English: Both syringes should be filled with equal volumes, and should not contain air bubbles.
Croatian: Obje štrcaljke potrebno je napuniti jednakim volumenom otopina, a nijedna ne smije sadržavati mjehuriće zraka.
English: If application of a single layer of EVICEL does not completely stop the bleeding, a second layer may be applied.
Croatian: Ako primjena jednog sloja lijeka EVICEL ne zaustavi krvarenje u potpunosti, može se primijeniti drugi sloj.
English: The amount of EVICEL that will be applied depends on the surface area of tissue to be treated during the operation.
Croatian: Količina lijeka EVICEL koja će se primijeniti ovisi o površini tkiva koja će se tretirati tijekom operacije.
English: For laparoscopy, see recommendations below.
Croatian: Za laparoskopiju, pogledajte preporuke u nastavku.
English: • If you are hypersensitive (allergic) to products made from human blood or to any of the other ingredients of EVICEL (listed in section 6).
Croatian: • ako ste preosjetljivi (alergični) na lijekove dobivene iz ljudske krvi ili neki drugi sastojak lijeka EVICEL (naveden u dijelu 6.).
English: Analysis of cerebrospinal fluid did not reveal major signs of inflammation.
Croatian: Analiza cerebrospinalnog likvora nije otkrila značajnije znakove upale.
English: In isolated cases, these reactions have progressed to severe anaphylaxis.
Croatian: U izoliranim slučajevima te se reakcije mogu razviti do teške anafilaksije.
English: • The educational package should contain: o The Summary of Product Characteristics o The section titled “The following information is intended for medical or healthcare professionals only” of the latest package leaflet.
Croatian: • Edukacijski paket treba sadržavati: o sažetak opisa svojstava lijeka o dio pod naslovom „Sljedeće su informacije namijenjene samo zdravstvenim radnicima“ iz najnovije upute o lijeku.
English: No allergic reactions have so far been reported in patients treated with EVICEL.
Croatian: Do sada nisu prijavljene alergijske reakcije u bolesnika liječenih lijekom EVICEL.
English: What you need to know before you use EVICEL
Croatian: Što morate znati prije nego primite EVICEL
English: Pharmacotherapeutic group: local haemostatics, combinations, ATC code: B02BC30
Croatian: Farmakoterapijska skupina: lokalni hemostatici, kombinacije, ATK oznaka: B02BC30
English: Keeping the tip of the applicator as close to the tissue surface as possible, but without touching the tissue during application, apply individual drops to the area to be treated.
Croatian: Držeći nastavak aplikatora što bliže površini tkiva, ali ne dodirujući tkivo tijekom primjene, nanesite pojedinačne kapi na područje koje se tretira.
English: • Pressure regulators do not exceed the maximum pressure of 1.7 bars for spraying EVICEL, and contain labels stating the recommended pressure and distance.
Croatian: • Regulatori tlaka ne premašuju maksimalni tlak od 1,7 bara za EVICEL koji se raspršuje te sadrže naljepnice na kojima je navedena preporučena vrijednost tlaka i udaljenost.
English: If the tag is provided as part of the medicinal product, it should be incorporated in the product information via a variation procedure
Croatian: Ako se oznaka isporučuje kao dio lijeka, mora se, kroz postupak izmjene, uvrstiti u informacije o lijeku.
English: Such substances should be removed to the greatest possible extent before applying the product.
Croatian: Takve tvari potrebno je što je više moguće ukloniti prije primjene ovog lijeka.
English: What EVICEL contains
Croatian: Što EVICEL sadrži
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 uvjetovana je varijablama koje uključuju, ali nisu ograničene na vrstu kirurške intervencije, veličinu područja i način željene primjene te broj primjena.
English: This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the tissue surface.
Croatian: Čini se da je ovaj događaj povezan s uporabom raspršivača pri tlakovima višima od preporučenih i/ili u neposrednoj blizini površine tkiva.
English: Factor XIIIa, which is activated from Factor XIII by thrombin, crosslinks fibrin.
Croatian: Faktor XIIIa, koji nastaje aktivacijom faktora XIII trombinom, ukriženo povezuje fibrin.
English: The pressure regulator should be used in accordance with the manufacturer's instructions.
Croatian: Regulator tlaka potrebno je koristiti u skladu s uputama proizvođača.
English: • When EVICEL is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue.
Croatian: • Kad se EVICEL primjenjuje tijekom kirurškog zahvata, kirurg mora osigurati da se primijeni samo na površinu tkiva.
English: Fibrin sealants in general may, in rare cases (up to 1 patient in 1,000 people), cause an allergic reaction.
Croatian: Fibrinska tkivna ljepila općenito mogu u rijetkim slučajevima (u do 1 na 1000 osoba) uzrokovati alergijske reakcije.
English: Therefore, the product should be administered to pregnant and breast-feeding women only if clearly needed.
Croatian: Stoga se ovaj lijek smije primijeniti u trudnica i dojilja samo ako je to uistinu nužno.
English: • Nearby areas should be protected to make sure that EVICEL is only applied onto the surface which is to be treated.
Croatian: • Okolna područja potrebno je zaštititi kako bi se osiguralo da se EVICEL primijeni samo na površinu koju treba tretirati.
English: The date on which refrigerator storage was started should be marked on the carton in the space provided.
Croatian: Datum početka čuvanja lijeka u hladnjaku treba naznačiti na kutiji u za to predviđenom prostoru.
English: Omrix Biopharmaceuticals Ltd Pharmacovigilance Department Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat Gan 5262000, Israel Tel: +972-3-5316512
Croatian: Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat Gan 5262000, Izrael Tel: +972-3-5316512
English: Before administration of EVICEL, care is to be taken that parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Croatian: Prije primjene lijeka EVICEL treba paziti da su dijelovi tijela izvan željenog područja primjene zaštićeni (prekriveni) na odgovarajući način kako bi se spriječila adhezija tkiva na neželjenim mjestima.
English: 50 - 90 mg 100 - 180 mg 250 - 450 mg
Croatian: 100-180 mg 250-450 mg
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača bioloških djelatnih tvari
English: At 30 days post-operatively the incidence of SSIs was similar between the two treatment groups.
Croatian: 30 dana nakon operacije incidencija infekcija operativnog mjesta bila je podjednaka u dvije skupina ispitanika.
English: There is not enough information available to know whether any particular risks are associated with the use of EVICEL during pregnancy or whilst breast-feeding.
Croatian: Nema dovoljno podataka da bi se znalo postoji li neki poseban rizik povezan s primjenom lijeka EVICEL tijekom trudnoće ili dojenja.
English: The fibrinogen and thrombin components are stable at room temperature for up to 24 hours but when they have been drawn up into the administration device, they must be used immediately.
Croatian: Komponente fibrinogen i trombin su stabilni na sobnoj temperaturi do 24 sata, ali nakon što se navuku u aplikator, moraju se odmah upotrijebiti.
English: There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.
Croatian: Postoji također teoretska mogućnost da razvijete protutijela na proteine u lijeku EVICEL, što bi potencijalno moglo ometati zgrušavanje krvi.
English: o Healthcare professionals training material
Croatian: o edukacijski materijal za zdravstvene radnike
English: I-thrombin it was shown that a slow absorption of biologically inactive peptides resulting from the breakdown of thrombin occurred, reaching a Cmax in the plasma after 6-8 hours.
Croatian: I-trombina dokazano je da dolazi do spore apsorpcije biološki neaktivnih peptida nastalih razgradnjom trombina, dosežući Cmax u plazmi nakon 6-8 sati.
English: • surgery to the brain or spinal cord except for support of watertight closure of cerebral envelopes (dura mater)
Croatian: • kirurških zahvata na mozgu ili leđnoj moždini osim potpore nepropusnom zatvaranju moždanih ovojnica (dura mater)
English: After local application, absorption of thrombin into the plasma is slow and consists principally of thrombin degradation products which are eliminated.
Croatian: Nakon lokalne primjene apsorpcija trombina u plazmu je spora i sastoji se pretežno od produkata razgradnje trombina koji se eliminiraju.
English: The fibrinogen and thrombin components are stable at room temperature for up to 24 hours.
Croatian: Komponente fibrinogen i trombin stabilne su na sobnoj temperaturi do 24 sata.
English: To be used as two-component product with supplied device.
Croatian: Koristi se kao dvokomponentni lijek s isporučenim aplikatorom.
English: The doctor treating you will administer EVICEL during surgery.
Croatian: Liječnik koji Vas liječi primijenit će EVICEL tijekom kirurškog zahvata.
English: The following side effects which occurred during clinical studies were considered to be related to the use of EVICEL:
Croatian: Za sljedeće nuspojave koje su se pojavile tijekom kliničkih ispitivanja, smatra se da su povezane s primjenom lijeka EVICEL:
English: The healthcare professionals will record the name and batch number of the medicinal product in order to trace any possible infection source.
Croatian: Zdravstveni radnici će u povijest bolesti zabilježiti naziv i broj serije lijeka kako bi se mogao pratiti trag eventualnog izvora infekcije.
English: EVICEL is indicated in adults as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis (see section 5.1).
Croatian: EVICEL je indiciran u odraslih kao potporno sredstvo kod kirurških zahvata u kojima standardne kirurške tehnike nisu dostatne, a za poboljšanje hemostaze (vidjeti dio 5.1).
English: The instructions for use are also described in the healthcare professionals package leaflet part.
Croatian: Upute za uporabu također su opisane u dijelu upute o lijeku namijenjenom zdravstvenim radnicima.
English: EVICEL is available in the following pack sizes: 2 x 1 ml, 2 x 2 ml, and 2 x 5 ml.
Croatian: EVICEL je dostupan u sljedećim veličinama pakiranja: 2 x 1 ml, 2 x 2 ml i 2 x 5 ml.
English: Data are too limited to support the safety and effectiveness of EVICEL in children and adolescents.
Croatian: Premalo je podataka da bi se mogla poduprijeti sigurnost i učinkovitost lijeka EVICEL u djece i adolescenata.
English: EVICEL forms a clear film over the area of application.
Croatian: EVICEL stvara proziran film preko područja primjene.
English: The product should only be reconstituted and administered according to the instructions and with the devices recommended for this product.
Croatian: Lijek treba rekonstituirati i primijeniti samo u skladu s uputama i s napravama koje se preporučuju za ovaj lijek.
English: Manufacturers of these products also include steps in the processing of the blood and plasma that can inactivate or remove viruses.
Croatian: Proizvođači ovih lijekova također tijekom obrade krvi i plazme primjenjuju postupke koji mogu inaktivirati ili ukloniti viruse.
English: Human Fibrinogen and Human Thrombin: Omrix Biopharmaceuticals Ltd.
Croatian: Humani fibrinogen i humani trombin: Omrix Biopharmaceuticals Ltd.
English: • controlling bleeding in the stomach or intestines by applying the product through an endoscope (tube)
Croatian: • kontrole krvarenja u želucu ili crijevima primjenom kroz endoskop (cjevčicu)
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 nedostatna su za procjenu sigurnosti primjene s obzirom na reprodukciju, razvoj embrija ili fetusa, tijek gestacije te perinatalni i postnatalni razvoj.
English: What EVICEL looks like and contents of the pack
Croatian: Kako EVICEL izgleda i sadržaj pakiranja
English: The application device should be stored at room temperature, separately from the fibrinogen and thrombin.
Croatian: Aplikator za primjenu lijeka se treba čuvati na sobnoj temperaturi, odvojeno od fibrinogena i trombina.
English: Distance from target tissue
Croatian: Udaljenost od ciljnog tkiva
English: If the applicator tip becomes blocked, the catheter tip can be cut back in 0.5 cm increments.
Croatian: Ako se nastavak aplikatora začepi, vršak katetera može se svaki puta odrezati za 0,5 cm.
English: For laparoscopy, see section 4.4.
Croatian: Za laparoskopske postupke, vidjeti dio 4.4.
English: Fibrinogen is a concentrate of clottable protein and thrombin is an enzyme that causes clottable protein to coalesce.
Croatian: Fibrinogen je koncetrat proteina sa sposobnošću zgrušavanja, a trombin je enzim koji uzrokuje sljepljivanje proteina sa sposobnošću zgrušavanja.
English: The frequency of the effects listed above was common (may affect up to 1 in 10 people).
Croatian: Gore navedene nuspojave bile su česte (mogu se pojaviti u do 1 na 10 osoba).
English: The accessory tips should only be used by persons adequately trained in laparoscopic, laparoscopic-assisted, or open surgical procedures.
Croatian: Dodatne nastavke smiju koristiti samo osobe koje su na odgovarajući način obučene za laparoskopske, laparoskopijom potpomognute ili otvorene kirurške zahvate.
English: EVICEL must not be injected into tissue or blood vessels because it would cause clots which could be fatal.
Croatian: EVICEL se ne smije injicirati u tkivo ili krvne žile jer bi uzrokovao stvaranje ugrušaka koji mogu biti smrtonosni.
English: The product should only be administered according to the instructions and with the devices recommended for this product (see section 6.6).
Croatian: Lijek treba primijeniti samo prema uputama i pomoću naprava preporučenih za ovaj lijek (vidjeti dio 6.6).
English: What EVICEL is and what it is used for What you need to know before you use EVICEL How to use EVICEL
Croatian: Što je EVICEL i za što se koristi Što morate znati prije nego primite EVICEL Kako primjenjivati EVICEL Moguće nuspojave
English: Human clottable protein containing mainly fibrinogen and fibronectin *
Croatian: Humani protein sa sposobnošću zgrušavanja koji sadrži uglavnom fibrinogen i fibronektin*
English: The frequency of all of these effects was common.
Croatian: Sve ove nuspojave bile su česte.
English: EVICEL comes in sterile packages and therefore it is important to use only undamaged packages which have not been opened (post-sterilisation is not possible).
Croatian: Pročitajte ove upute prije nego otvorite pakiranje EVICEL se isporučuje u sterilnim pakiranjima te je stoga važno da upotrijebite samo neoštećena pakiranja koja nisu otvarana (naknadna sterilizacija nije moguća).
English: For spray application see sections 4.4 and 6.6 for specific recommendations on the required pressure and distance from tissue per surgical procedure and length of applicator tip.
Croatian: Za primjenu spreja vidjeti dijelove 4.4 i 6.6 za specifične preporuke o potrebnom tlaku i udaljenosti od tkiva ovisno o kirurškom zahvatu i duljini vrha aplikatora.
English: The Marketing Authorisation 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 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • In accordance with the European Commission decision on the procedure EMEA/H/C/000898/A20/0018 to mitigate the risk of potentially life threatening air/gas embolism when the product is sprayed at higher than recommended pressures and/or in close proximity to the tissue surface, the MAH shall ensure that: - When EVICEL is sprayed using pressurized gas, the gas should be carbon dioxide because the greater solubility of carbon dioxide in blood reduces the risk of embolism.
Croatian: • Dodatne mjere minimizacije rizika U skladu s odlukom Europske komisije o postupku EMEA/H/C/000898/A20/0018 za smanjenje rizika od potencijalno po život opasne zračne/plinske embolije kada se lijek raspršuje pod tlakom višim od preporučenog i/ili u neposrednoj blizini površine tkiva, nositelj odobrenja će osigurati da: - kada se EVICEL raspršuje s pomoću stlačenog plina, plin treba biti ugljični dioksid jer veća topljivost ugljičnog dioksida u krvi smanjuje rizik od embolije, - EVICEL se ne raspršuje putem endoskopa ako se preporučena minimalna sigurna udaljenost od tkiva ne može postići.
English: 5 How to store EVICEL Contents of the pack and other information
Croatian: Kako čuvati EVICEL Sadržaj pakiranja i druge informacije
English: The MAH shall ensure that in each Member State where Evicel is marketed, all healthcare professionals who are using Evicel are provided with an educational package aiming at increasing awareness about the risk of life-threatening gas embolism if the product is sprayed incorrectly and providing guidance on how to manage that risk:
Croatian: Nositelj odobrenja će osigurati da svaka država članica na čijem tržištu se nalazi Evicel, svi zdravstveni radnici koji primjenjuju Evicel dobiju edukacijski paket s ciljem podizanja svijesti o riziku od po život opasne plinske embolije ako se lijek nepravilno raspršuje te da dobiju smjernice o upravljanju tim rizikom:
English: No toxicological effects due to the solvent detergent reagents (TnBP and Triton X-100) used in the virus inactivation procedure are expected since the residual levels are less than 5 µg/ml.
Croatian: Ne očekuju se toksikološki učinci zbog djelovanja reagensa otapala/deterdženta (TnBP i Triton X-100) koji se koriste za inaktivaciju virusa, jer su ostatne razine manje od 5 µg/ml.
English: It is dripped or sprayed onto cut tissue where it forms a thin layer that seals the tissue and/or stops bleeding.
Croatian: Lijek se kapa ili raspršuje po rezu tkiva gdje stvara tanak sloj koji zatvara tkivo i/ili zaustavlja krvarenje.
English: Adequate data are not available to support the use of this product in tissue gluing, application through a flexible endoscope for treatment of bleeding, or in gastrointestinal anastomoses.
Croatian: Nisu dostupni odgovarajući podaci koji bi poduprli primjenu ovog lijeka za lijepljenje tkiva, za primjenu kroz fleksibilni endoskop radi zaustavljanja krvarenja ili kod gastrointestinalnih anastomoza.
English: Inadvertent intravascular injection could lead to thromboembolic event and disseminated intravascular coagulation (DIC), and there is also a risk of anaphylactic reaction (see section 4.4).
Croatian: Slučajna injekcija u krvnu žilu može uzrokovati tromboembolijski događaj i diseminiranu intravaskularnu koagulaciju (DIK), a postoji i rizik od anafilaktičke reakcije (vidjeti dio 4.4).
English: Pressure regulator to be used
Croatian: Regulator tlaka koji se koristi
English: EVICEL can also be used to support the watertight closure of the cerebral envelopes (dura mater) during neurosurgery when other surgical techniques are insufficient.
Croatian: EVICEL se također može koristiti kao potpora za nepropusno zatvaranje moždanih ovojnica (dura mater) pri neurokirurškim operacijama kada su ostale kirurške tehnike nedostatne.
English: Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.
Croatian: Konverzija fibrinogena u fibrin događa se cijepanjem fibrinogena u fibrinske monomere i fibrinopeptide.