FrancophonIA/ELRC3.0 huggingface dataset:
English: No major macroscopic signs of local intolerance and no treatment-related macroscopic findings were observed.
Croatian: Nisu zamijećeni makroskopski znakovi lokalne nepodnošljivosti te nisu primijećene makroskopske promjene povezane s primjenom lijeka.
English: Studies have been conducted in rabbits to evaluate the absorption and elimination of thrombin when applied to the cut surface of the liver resulting from partial hepatectomy.
Croatian: Provedena su ispitivanja na kunićima radi procjene apsorpcije i eliminacije trombina kada se lijek primjenjivao na izrezanu površinu jetre kod djelomične hepatektomije.
English: POB 888, Kiryat Ono 5510801 Israel
Croatian: Kiryat Ono 5510801
English: • As with any product containing proteins, allergic-type hypersensitivity reactions are possible.
Croatian: • Kao i kod svakog lijeka koji sadrži proteine, moguće su alergijske reakcije preosjetljivosti.
English: In controlled clinical trials in vascular surgery, the individual dosage used was up to 4 ml; for suture line sealing in dura mater closure, doses of up to 8 ml were used, whereas in retroperitoneal or intra-abdominal surgery the individual dosage used was up to 10 ml.
Croatian: U kontroliranim kliničkim ispitivanjima primjene u kirurgiji krvnih žila primjenjivale su se pojedinačne doze do 4 ml, za zatvaranje linije šava dure mater primjenjivane su doze do 8 ml, dok su u retroperitonealnim ili intraabdominalnim kirurškim zahvatima korištene pojedinačne doze do 10 ml.
English: The vials can be stored at room temperature for up to 24 hours.
Croatian: Bočice se mogu čuvati na sobnoj temperaturi do 24 sata.
English: Calcium ions are required for both, the conversion of fibrinogen and the crosslinking of fibrin.
Croatian: Kalcijevi ioni potrebni su za oba procesa, i za konverziju fibrinogena i za ukriženo povezivanje fibrina.
English: The safety of fibrin sealants/haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Croatian: Sigurnost primjene fibrinskih tkivnih ljepila/hemostatika tijekom trudnoće ili dojenja nije ustanovljena u kontroliranim kliničkim ispitivanjima.
English: All concentrations of the combination of TnBP and Triton X-100 also tested negative in assays performed to determine mammalian cell mutagenicity, chromosomal aberrations and micronuclei induction.
Croatian: Sve koncentracije kombinacija TnBP-a i Tritona X-100 također su bile negativne u testovima utvrđivanja mutagenog djelovanja na stanice sisavaca, kromosomskih aberacija te indukcije mikronukleusa.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove : http://www.ema.europa.eu/.
English: EVICEL is applied in adults during surgical operations to reduce bleeding and oozing during and after the operation.
Croatian: EVICEL se primjenjuje u odraslih tijekom kirurških zahvata za smanjivanje krvarenja i iscjetka iz rane za vrijeme i nakon operacije.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To vrijedi i za nepoznate viruse ili one koji se tek pojavljuju i za druge patogene.
English: The volume of EVICEL to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
Croatian: Volumen lijeka EVICEL koji će se primijeniti te učestalost primjene uvijek moraju biti određeni prema postojećim kliničkim potrebama bolesnika.
English: Studies performed in bacteria to determine mutagenicity were negative for thrombin alone, Biological Active Component (containing fibrinogen, citrate, glycine, tranexamic acid, and arginine hydrochloride), TnBP alone, and Triton X-100 alone at all concentrations tested.
Croatian: Ispitivanja provedena na bakterijama s ciljem utvrđivanja mutagenosti bila su negativna za sam trombin, biološku djelatnu tvar (koja sadrži fibrinogen, citrat, glicin, traneksaminsku kiselinu te argininklorid), sam TnBP i sam Triton X-100 u svim ispitanim koncentracijama.
English: Discard unused product after 24 hours at room temperature.
Croatian: Zbrinite u otpad neupotrijebljeni lijek nakon 24 sata na sobnoj temperaturi.
English: Omrix Biopharmaceuticals N.V. Leonardo Da Vinci Laan 15 B-1831 Diegem
Croatian: Leonardo Da Vinci Laan 15 B-1831 Diegem
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of viruses/infections.
Croatian: One obuhvaćaju pažljiv odabir darivatelja krvi i plazme kako bi se osiguralo isključivanje darivatelja koji su rizični za prijenos infekcije, kao i testiranje svake darovane doze i “pulova” (objedinjenih doza) plazme na prisutnost virusa/infekcije.
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: • Kada se lijekovi dobivaju iz ljudske krvi ili plazme, primjenjuju se određene mjere za sprečavanje prijenosa zaraznih bolesti na bolesnike.
English: Neurotoxicity studies performed with EVICEL confirmed that subdural administration in the rabbit was not associated with any evidence of neurotoxicity.
Croatian: Ispitivanja neurotoksičnosti provedena s lijekom EVICEL potvrdila su da subduralna primjena u kunića nije povezana s bilo kojim znakom neurotoksičnosti.
English: CARTON BOX
Croatian: KARTONSKA KUTIJA
English: Omrix Biopharmaceuticals Ltd. Jerusalem Plant (Omrix-JP) 5 Kiryat Hamada St., Ramot Meir Building Har-Hotzvim P.O.B.
Croatian: Jerusalem Plant (Omrix-JP) 5 Kiryat Hamada St., Ramot Meir Building Har-Hotzvim P.O.B. 45075
English: Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g., antiseptic solutions).
Croatian: Poput sličnih lijekova ili otopina trombina i ovaj se lijek može denaturirati nakon izlaganja otopinama koje sadrže alkohol, jod ili teške metale (npr. otopine antiseptika).
English: As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Croatian: Kako cijeljenje rane napreduje, povećava se fibrinolitička aktivnost potaknuta plazminom i pokreće se razgradnja fibrina na njegove razgradne produkte.
English: This device allows equal amounts of the two components of EVICEL to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to have its optimal effect.
Croatian: Aplikator omogućuje istodobnu primjenu jednakih količina obiju komponenti lijeka EVICEL i njihovo ujednačeno miješanje, što je važno za postizanje optimalnog učinka tkivnog ljepila.
English: Draw the contents of the two vials into the application device, following the instructions for use in the device package.
Croatian: Navucite sadržaj dviju bočica u aplikator slijedeći upute za uporabu priložene u pakiranju aplikatora.
English: Before use, the product must reach 20-30°C.
Croatian: Prije uporabe lijek mora dostići temperaturu od 20 - 30°C.
English: Neurobehavioral observations for 14±1 days showed no abnormal findings.
Croatian: U nalazima promatranja neurobihevioralnog statusa tijekom 14 ± 1 dana nisu zabilježena odstupanja.
English: The MAH shall ensure that all users of the spray application of this product are provided with: - labels for the pressure regulator that inform about the correct pressures and distances in open and laparoscopic procedures - a warning card that informs about the correct pressures and distances for the spray application for open and laparoscopic procedures - a tag, to be placed on the device air hose, which provides instructions for use.
Croatian: Nositelj odobrenja će osigurati da svi korisnici koji primjenjuju ovaj lijek raspršivanjem dobiju: - naljepnice za regulatore tlaka na kojima su naznačeni točni tlakovi i udaljenosti za nanošenje raspršivanjem, za otvorene i laparoskopske zahvate - karticu s upozorenjem koja pokazuje točne tlakove i udaljenosti za primjenu raspršivanjem, za otvorene i laparoskopske zahvate - oznaku koju treba postaviti na cijev za zrak na uređaju, a koja daje upute za primjenu.
English: Such reactions may especially be seen if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Croatian: Takve se reakcije mogu naročito pojaviti u bolesnika u kojih se lijek primjenjuje više puta ili ako se lijek primjenjuje bolesnicima koji su preosjetljivi na njegove sastojke.
English: This also applies to any unknown or emerging viruses, or other types of infections.
Croatian: To vrijedi i za nepoznate viruse, ili one koji se tek pojavljuju te za druge vrste infekcija.
English: Excessive clot thickness may negatively interfere with the product's efficacy and the wound healing process
Croatian: Prekomjerna debljina ugruška može negativno interferirati s djelotvornošću lijeka i procesom cijeljenja rane.
English: EVICEL must be sprayed using pressurised CO2 only.
Croatian: EVICEL se smije primijeniti samo raspršivanjem pomoću stlačenog CO2.
English: A non-interventional post-authorisation safety study was conducted which involved 300 patients undergoing vascular surgery during which EVICEL was used.
Croatian: Provedeno je neintervencijsko ispitivanje sigurnosti lijeka nakon davanja odobrenja u koje je bilo uključeno 300 bolesnika podvrgnutih kirurškim postupcima na krvnim žilama pri kojima je primijenjen EVICEL.
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Croatian: Poduzete mjere mogu imati ograničenu djelotvornost protiv virusa bez ovojnice, poput parvovirusa B19.
English: • EVICEL should not be used in endoscopic surgery.
Croatian: • EVICEL nije za uporabu u endoskopskoj kirurgiji.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere za sprečavanje infekcija koje mogu nastati primjenom lijekova pripravljenih iz ljudske krvi ili plazme obuhvaćaju odabir darivatelja krvi, probir pojedinačnih donacija i pulova plazme na specifične biljege infekcije i poduzimanje učinkovitih koraka tijekom proizvodnje za inaktivaciju/uklanjanje virusa.
English: Once drawn up into the application device, they must be used immediately.
Croatian: Nakon što se navuče u aplikator, mora se odmah upotrijebiti.
English: All pack sizes may not be marketed in all countries
Croatian: Na tržištu svih zemalja se ne moraju nalaziti sve veličine pakiranja.
English: For safety with respect to transmissible agents, see section 4.4.
Croatian: Za podatke o sigurnosti lijeka s obzirom na prenosive infektivne agense, vidjeti dio 4.4.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica u nastavku je u skladu s MedDRA klasifikacijom organskih sustava (KOS i razina preporučenih pojmova).
English: Post-operative CSF leakage occurred within 30 days from treatment in 4/89 (4.5%) subjects treated with EVICEL (two cases of CSF leakage with impaired wound healing and two cases of rhinorrhoea) and in 1/50 (2.0%) subjects treated with additional sutures.
Croatian: Postoperativno istjecanje cerebrospinalnog likvora dogodilo se unutar 30 dana od primjene lijeka u 4/89 (4,5%) ispitanika u kojih je primijenjen EVICEL (dva slučaja istjecanja likvora s lošim zacjeljivanjem rane i dva slučaja rinoreje) te u 1/50 (2,0%) ispitanika u kojih su primijenjeni dodatni šavovi.
English: As a consequence, intravascular pharmacokinetic studies were not performed in man.
Croatian: Stoga nisu provedena farmakokinetička ispitivanja intravaskularne primjene u ljudi.
English: The incidence of CSF leakage and the incidence of Surgical Site Infections were monitored as safety endpoints in the study.
Croatian: Incidencija istjecanja cerebrospinalnog likvora i incidencija infekcija operativnog mjesta nadzirane su kao sigurnosne mjere ishoda ispitivanja.
English: Safety monitoring focused on the specific adverse reactions of graft patency, thrombotic events, and bleeding events.
Croatian: Nadzor sigurnosti primjene bio je usmjeren na specifične nuspojave u prohodnosti graftova, trombotičkim događajima i krvarenjima.
English: Do not use EVICEL
Croatian: Nemojte primiti EVICEL
English: Of 135 patients undergoing retroperitoneal and intra-abdominal surgery who were included in the controlled study of EVICEL, 4 patients treated with EVICEL were aged 16 years or younger.
Croatian: Od 135 bolesnika podvrgnutih retroperitonealnom ili intrabdominalnom kirurškom zahvatu koji su bili uključeni u kontrolirano ispitivanje lijeka EVICEL, 4 bolesnika koja su primila EVICEL bila su u dobi od 16 godina ili mlađa.
English: The new expiry date at 2°C-8C should be noted on the carton but should not exceed the expiry date printed by the manufacturer on the carton and label.
Croatian: Novi datum roka valjanosti na temperaturi od 2°C - 8 °C potrebno je zabilježiti na kutiji, ali on ne smije prelaziti rok valjanosti koji je proizvođač otisnuo na kutiju i naljepnicu.
English: However, since EVICEL is used during a surgical operation, if you are pregnant or breast-feeding, you should discuss the overall risks of the operation with your doctor.
Croatian: Međutim, s obzirom da se EVICEL primjenjuje tijekom kirurškog zahvata, ako ste trudni ili dojite, obratite se svom liječniku za savjet prije nego primite ovaj lijek i raspravite s njim ukupan rizik od kirurškog zahvata.
English: When using accessory tips with this product, the instructions for use of the tips should be followed.
Croatian: Kada se s ovim lijekom koriste dodatni nastavci, treba se pridržavati uputa za uporabu tih nastavaka.
English: EVICEL is a human fibrin sealant which is supplied as a package containing two separate glass vials.
Croatian: EVICEL je humano fibrinsko tkivno ljepilo koje se isporučuje u kutiji s dvije odvojene staklene bočice.
English: Connect the female luer-lock of the gas tube (with the 0.2 μm bacteriostatic filter) to a pressure regulator.
Croatian: Spojite ženski luernastavak plinske cijevi (s bakteriostatskim filtrom veličine pora 0,2 μm) na regulator tlaka.
English: Spray distance from tissue and CO2 pressure should be within the ranges recommended by the manufacturer (see table in section 6.6 for pressure and distance).
Croatian: Udaljenost od tkiva i tlak CO2 moraju biti unutar raspona koje preporučuje proizvođač (za tlakove i udaljenosti, vidjeti tablicu u dijelu 6.6).
English: The events were evenly distributed across treatment arms, with 8 each in the EVICEL and the control groups.
Croatian: Ti su događaji bili podjednako raspodijeljeni u obje ispitivane skupine, s po 8 događaja u skupini u kojoj je primijenjen EVICEL i u kontrolnoj skupini.
English: Other side effects which were reported to be common during clinical trials with EVICEL (i.e., may affect up to 1 in 10 people) included meningitis, and accumulation of CSF fluid in the brain cavities (hydrocephalus).
Croatian: Ostale nuspojave prijavljene kao česte tijekom kliničkih ispitivanja lijeka EVICEL (mogu se pojaviti u do 1 na 10 osoba) uključuju, meningitis i nakupljanje cerebrospinalnog likvora u moždanim komorama (hidrocefalus).
English: For storage conditions after thawing of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja nakon odmrzavanja lijeka vidjeti dio 6.3.
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/haemostatics.
Croatian: Reakcije preosjetljivosti ili alergijske reakcije (koje mogu uključivati angioedem, žarenje ili pečenje na mjestu primjene, bronhospazam, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje (pri disanju)) mogu nastupiti u rijetkim slučajevima u bolesnika kojima su primijenjena fibrinska tkivna ljepila/hemostatici.
English: Store in the outer carton at -18°C or colder, to protect from light.
Croatian: Čuvati u vanjskom pakiranju na temperaturi od -18°C ili nižoj, radi zaštite od svjetlosti.
English: Do not use solutions that are cloudy or have deposits.
Croatian: Ne smiju se upotrijebiti otopine koje su zamućene ili imaju talog.
English: Recommended spray pressure
Croatian: Preporučeni tlak raspršivanja
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Croatian: Usprkos tim mjerama, kada se primjenjuju lijekovi pripremljeni iz ljudske krvi ili plazme, ne može se potpuno isključiti mogućnost prijenosa infekcije.
English: Each contains 1 ml, 2 ml or 5 ml solution of human fibrinogen and human thrombin, respectively.
Croatian: Svaka sadrži 1 ml, 2 ml ili 5 ml otopine humanog fibrinogena odnosno humanog trombina.
English: • sealing in transphenoidal and otoneurosurgical procedures
Croatian: • lijepljenja kod transsfenoidalnih i otoneurokirurških postupaka
English: At the end of this period the product has to be used or discarded.
Croatian: Na kraju tog razdoblja lijek se mora primjeniti ili zbrinuti u otpad.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded.
Croatian: Usprkos tome, kada se primjenjuju lijekovi pripremljeni iz ljudske krvi ili plazme, ne može se potpuno isključiti mogućnost prijenosa infektivnih agensa.
English: It is strongly recommended that every time EVICEL 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: Posebno se preporučuje da se kod svake primjene lijeka EVICEL na bolesniku u povijest bolesti zabilježi naziv lijeka i broj serije, kako bi se održao trag veze između bolesnika i serije lijeka.
English: After thawing, unopened vials can be stored at 2°C-8°C and protected from light, for up to 30 days, without being frozen again during this period.
Croatian: Nakon odmrzavanja, neotvorene bočice mogu se čuvati na temperaturi od 2°C - 8°C i zaštićene od svjetlosti najdulje 30 dana, bez ponovnog zamrzavanja tijekom tog razdoblja.
English: It is not known whether radiation therapy could affect the efficacy of fibrin sealant when used for suture line sealing in dura mater closure.
Croatian: Nije poznato može li radioterapija utjecati na djelotvornost fibrinskog ljepila kada se ono primjenjuje za lijepljenje linije šava pri zatvaranju dure mater.
English: As with any protein product, allergic type hypersensitivity reactions are possible.
Croatian: Kao i sa svakim lijekom koji sadrži proteine, moguće su reakcije preosjetljivosti alergijskog tipa.
English: The use of EVICEL as a sealant in transphenoidal and otoneurosurgical procedures has not been studied.
Croatian: Primjena lijeka EVICEL kao ljepila u transsfenoidalnim i otoneurokirurškim postupcima nije ispitivana.
English: The use of EVICEL in patients undergoing radiotherapy within 7 days after surgery has not been evaluated.
Croatian: Nije ocijenjena primjena lijeka EVICEL u bolesnika podvrgnutih radioterapiji unutar 7 dana od operacije.
English: EVICEL spray application should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy.
Croatian: EVICEL se smije primjenjivati pomoću raspršivača samo ako je moguće točno procijeniti udaljenost raspršivanja, posebice tijekom laparoskopskih postupaka.
English: The fibrin monomers aggregate and form a fibrin clot.
Croatian: Fibrinski monomeri nakupljaju se i stvaraju fibrinski ugrušak.
English: It will be dripped onto the tissue in very small amounts or sprayed in short bursts (0.1-0.2 ml), to produce a thin, even layer.
Croatian: Lijek se nakapava na tkivo u kratkim štrcajima ili se raspršuje u vrlo malim količinama (0,1-0,2 ml) kako bi se stvorio tanak, ujednačen sloj.
English: No adverse reactions were reported during the study.
Croatian: Tijekom ispitivanja nisu prijavljene nuspojave.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Croatian: Za upute o pripremi lijeka prije primjene, vidjeti dio 6.6.
English: When applying EVICEL using a spray device, it has to be ensured that the pressure and the distance from the tissue are within the ranges recommended by the marketing authorisation holder of this product, as given in the following table:
Croatian: Kada se EVICEL primjenjuje raspršivačem, mora se osigurati da su upotrijebljeni tlak i udaljenost od tkiva unutar raspona koji preporučuje nositelj odobrenja za stavljanje lijeka u promet, prema prikazu u sljedećoj tablici:
English: The approved shelf life of EVICEL is 2 years storage at ≤ -18
Croatian: Odobreni rok valjanosti lijeka EVICEL je 2-godišnje čuvanje na temperaturi od ≤18°C.
English: An application device and appropriate accessory tips are supplied separately.
Croatian: Aplikator za primjenu lijeka i odgovarajući dodatni nastavci isporučuju se zasebno.
English: Connect the female luer lock of the gas tube (with the 0.2 μm bacteriostatic filter) to a pressure regulator.
Croatian: Spojite ženski luer-lock nastavak plinske cijevi (s bakteriostatskim filtrom veličine pora od 0,2 μm) na regulator tlaka.
English: The concomitant use of EVICEL for dural suture line sealing with implants from synthetic materials or dural patches has not been evaluated in clinical studies.
Croatian: Istodobna primjena lijeka EVICEL za zatvaranje linije šava dure lijepljenjem s implantatima od umjetnih materijala ili duralnim zakrpama nije ocijenjena u kliničkim ispitivanjima.
English: After thawing, store unopened vials in the outer carton at 2°C -8°C for up to 30 days starting on:
Croatian: Nakon odmrzavanja, neotvorene bočice čuvati u vanjskom pakiranju na temperaturi od 2°C - 8°C najdulje 30 dana počevši od:
English: Connect the short tube on the application device to the male luer-lock end of the long gas tube.
Croatian: Spojite kratku cijev na aplikatoru na muški kraj luer-nastavka duge plinske cijevi.
English: Spray distance from tissue and pressure should be within the ranges recommended by the manufacturer (see table in section Instructions for Use).
Croatian: Udaljenost raspršivača od tkiva i tlak moraju biti unutar raspona koje preporučuje proizvođač raspršivača (pogledajte tablicu u dijelu Upute za uporabu).
English: Most serious side effects - Watery fluid coming out of your wound or nose (CSF leakage/CSF rhinorrhea) - Headache, nausea, and vomiting (due to Subdural Hygroma, which is accumulation of CSF in the subdural space) - Fever, or prolonged constipation, flatulence (due to abdominal abscess)
Croatian: Najozbiljnije nuspojave - vodenasti iscjedak iz rane ili iz nosa (istjecanje likvora, rinoreja likvora) - glavobolja, mučnina i povraćanje (uzrokovano subduralnim higromom, to jest nakupljanjem cerebrospinalnog likvora u subduralnom prostoru) - vrućica ili dugotrajan zatvor, vjetrovi (uzrokovani abdominalnim apscesom)
English: • Use of EVICEL during neurosurgery in patients who are also being treated with implants or with dural patches has not been evaluated in clinical studies.
Croatian: • Primjena lijeka EVICEL u neurokirurškim postupcima kod bolesnika kod kojih su ugrađeni implantati ili postavljene duralne zakrpe nije ocijenjena u kliničkim ispitivanjima.