FrancophonIA/ELRC3.0 huggingface dataset:
English: If you feel unwell tell your doctor immediately, even if your symptoms are different from those just described.
Slovenian: Če se ne počutite dobro, nemudoma obvestite zdravnika, čeprav so vaši simptomi drugačni od zgoraj naštetih.
English: Read this before you open the package
Slovenian: Preberite, preden odprete ovojnino
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru šoka morate uvesti standardno zdravljenje.
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).
Slovenian: Zdravilo EVICEL je v sterilnem pakiranju, zato je pomembno, da uporabljate samo nepoškodovano pakiranje, ki še ni bilo odprto (naknadna sterilizacija ni možna).
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even those not prescribed.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: Analysis of cerebrospinal fluid did not reveal major signs of inflammation.
Slovenian: Analiza cerebrospinalnega likvorja ni pokazala poglavitnih znakov vnetja.
English: To be used as two-component product with supplied device.
Slovenian: Za uporabo kot dvokomponentni izdelek s priloženim pripomočkom.
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.
Slovenian: Če občutite katerega od zgoraj navedenih simptomov ali kateri koli drug simptom, povezan s kirurškim posegom, se nemudoma obrnite na zdravnika ali kirurga.
English: If the tag is provided as part of the medicinal product, it should be incorporated in the product information via a variation procedure
Slovenian: Če je oznaka na voljo kot del zdravila, mora biti vključena v informacije o zdravilu preko postopka za spremembo dovoljenja za promet z zdravilom.
English: For laparoscopy, see section 4.4.
Slovenian: Za laparoskopijo glejte poglavje 4.4.
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:
Slovenian: • Pri v nadaljevanju naštetih postopkih uporabe zdravila EVICEL niso preučevali, zato ni podatkov, ki bi dokazovali njegovo učinkovitost pri naslednjih postopkih:
English: In isolated cases, these reactions have progressed to severe anaphylaxis.
Slovenian: V posamičnih primerih so se te reakcije stopnjevale do resne oblike anafilaksije.
English: The date on which refrigerator storage was started should be marked on the carton in the space provided.
Slovenian: Datum začetka shranjevanja v hladilniku označite na škatli v označenem prostoru.
English: Of these, 2 were children aged 2 and 5 years and 2 were adolescents of 16 years.
Slovenian: Od teh sta bila dva preiskovanca otroka, stara med 2 in 5 let, dva preiskovanca pa mladostnika, stara 16 let.
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.
Slovenian: - regulatorji tlaka ne presežejo najvišjega tlaka 1,7 bara za napršitev zdravila EVICEL in vsebujejo oznake, ki navajajo priporočeni tlak in razdaljo.
English: As a consequence, intravascular pharmacokinetic studies were not performed in man.
Slovenian: Zaradi tega intravaskularne farmakokinetične študije pri ljudeh niso bile opravljene.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Fax: +972-3-5316590
Slovenian: Faks: +972-3-5316590
English: The healthcare professionals will record the name and batch number of the medicinal product in order to trace any possible infection source.
Slovenian: Zdravstveno osebje si zabeleži ime in serijsko številko zdravila zaradi sledljivosti do morebitnega vira okužbe.
English: Distance from target tissue
Slovenian: Razdalja od ciljnega tkiva
English: What EVICEL is and what it is used for
Slovenian: Kaj je zdravilo EVICEL in za kaj ga uporabljamo
English: The accessory tips should only be used by persons adequately trained in laparoscopic, laparoscopic-assisted, or open surgical procedures.
Slovenian: Nastavke smejo uporabljati samo osebe, ki so ustrezno usposobljene za laparoskopske, laparoskopsko asistirane ali odprte kirurške postopke.
English: Omrix Biopharmaceuticals Ltd Pharmacovigilance Department Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat Gan 5262000, Israel Tel: +972-3-5316512
Slovenian: Omrix Biopharmaceuticals Ltd Plasma Fractionation Institute Sheba Hospital, Tel Hashomer Ramat Gan 5262000, Izrael Tel: +972-3-5316512
English: Fibrin sealants in general may, in rare cases (up to 1 patient in 1,000 people), cause an allergic reaction.
Slovenian: Fibrinska lepila lahko na splošno v redkih primerih (pri največ 1 od 1000 bolnikov) povzročijo alergijsko reakcijo.
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).
Slovenian: • Če ste alergični (preobčutljivi) na zdravila, izdelana iz človeške krvi ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: However, for some procedures (e.g., liver traumata) larger volumes may be required.
Slovenian: Vendar bo morda treba pri določenih posegih (npr. poškodbe jeter) uporabiti večje volumne.
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.
Slovenian: Začetni uporabljeni volumen zdravila na izbranem anatomskem mestu ali površini mora biti dovolj velik, da pokrije celotno ciljno področje nanosa.
English: No major macroscopic signs of local intolerance and no treatment-related macroscopic findings were observed.
Slovenian: Niso opazili poglavitnih makroskopskih znakov lokalne intolerance ali z zdravljenjem povezanih makroskopskih odkritij.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Pharmacotherapeutic group: local haemostatics, combinations, ATC code: B02BC30
Slovenian: Farmakoterapevtska skupina: hemostatiki za lokalno zdravljenje, kombinacije, oznaka ATC: B02BC30
English: No adverse reactions were reported during the study.
Slovenian: Med študijo niso poročali o nobenih neželenih učinkih.
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.
Slovenian: Ni pričakovati toksikoloških učinkov zaradi topnih detergentov (TnBP in Triton X-100), ki se uporabljata v postopku inaktivacije virusov, ker rezidualne ravni ne presegajo 5 µg/ml.
English: - EVICEL is not sprayed via an endoscope when the recommended minimum safe distance from the tissue cannot be observed.
Slovenian: - se zdravilo EVICEL ne prši prek endoskopa, kadar priporočene najmanjše varne razdalje od tkiva ni mogoče spremljati.
English: • When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Slovenian: • Pri zdravilih, ki se izdelajo iz človeške krvi ali plazme, se izvajajo določeni ukrepi za preprečevanje prenosa okužb na bolnike.
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.
Slovenian: Na voljo ni dovolj podatkov, ki bi podpirali uporabo tega zdravila za lepljenje tkiv, uporabo prek fleksibilnega endoskopa za zdravljenje krvavitve ali pri gastrointestinalnih anastomozah.
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.
Slovenian: Podatki iz študij na živalih ne zadoščajo za oceno varnosti glede reprodukcije, razvoja zarodka ali plodu, poteka gestacije ter peri- in postnatalnega razvoja.
English: CARTON BOX
Slovenian: KARTONSKA ŠKATLA
English: 50 - 90 mg 100 - 180 mg 250 - 450 mg
Slovenian: 100-180 mg 250-450 mg
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.
Slovenian: I-trombinom so dokazali, da je absorpcija biološko inaktivnih peptidov, ki nastanejo pri razkroju trombina, počasna, in v plazmi doseže Cmax po 6-8 urah.
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.
Slovenian: Količina zdravila EVICEL, ki se uporabi, ter pogostnost uporabe se vedno določata glede na obstoječe klinične potrebe bolnika.
English: The vials must be stored in an upright position.
Slovenian: Viale morajo biti shranjene v pokončnem položaju.
English: At 30 days post-operatively the incidence of SSIs was similar between the two treatment groups.
Slovenian: Trideset dni po posegu je bila pojavnost okužb kirurškega mesta v obeh zdravljenih skupinah podobna.
English: The pressure regulator should be used in accordance with the manufacturer's instructions.
Slovenian: Regulator tlaka morate uporabljati v skladu z navodili izdelovalca.
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.
Slovenian: Aplikator je pripomoček, ki omogoča sočasno nanašanje enakih količin dveh raztopin zdravila EVICEL, hkrati pa zagotovi njuno enakomerno mešanje, kar je pomembno, da lepilo doseže optimalni učinek.
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.
Slovenian: Pred nanašanjem zdravila EVICEL morate dele telesa, ki so zunaj želenega območja nanašanja zdravila, ustrezno zaščititi (prekriti), da preprečite lepljenje tkiv na neželenih mestih.
English: After local application, absorption of thrombin into the plasma is slow and consists principally of thrombin degradation products which are eliminated.
Slovenian: Po lokalnem nanosu je absorpcija trombina v plazmo počasna, in sicer gre predvsem za absorpcijo razgradnih produktov trombina, ki se eliminirajo.
English: At the end of this period the product has to be used or discarded.
Slovenian: Ob koncu tega obdobja je treba zdravilo porabiti ali zavreči.
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.
Slovenian: Take reakcije lahko nastopijo zlasti pri ponavljajoči uporabi zdravila ali pri bolnikih, za katere je znano, da so preobčutljivi za sestavine zdravila..
English: The approved shelf life of EVICEL is 2 years storage at ≤ -18
Slovenian: Odobreni rok uporabnost zdravila EVICEL je 2 leti ob shranjevanju pri ≤ -18 °C.
English: For epilesional use.
Slovenian: Za epilezijsko uporabo.
English: What you need to know before you use EVICEL
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo EVICEL
English: If the applicator tip becomes blocked, the catheter tip can be cut back in 0.5 cm increments.
Slovenian: Če se nastavek aplikatorja zamaši, lahko katetrski nastavek odrežete po 0,5-centimetrskih korakih.
English: It is dripped or sprayed onto cut tissue where it forms a thin layer that seals the tissue and/or stops bleeding.
Slovenian: Zdravilo nakapamo ali razpršimo na tkivo, kjer tvori tanek sloj, ki zalepi tkivo in/ali zaustavi krvavitev.
English: The product should only be reconstituted and administered according to the instructions and with the devices recommended for this product.
Slovenian: Zdravilo se sme rekonstituirati in nanašati samo po navodilih in s pripomočki, priporočenimi za to zdravilo.
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.
Slovenian: V skladu s sklepom - Evropske komisije o postopku EMEA/H/C/000898/A20/0018 za zmanjšanje tveganja potencialno življenjsko nevarne zračne/plinske embolije, kadar je zdravilo napršeno z višjim tlakom od priporočenega in/ali preblizu površine tkiva, mora imetnik dovoljenja za promet zagotoviti, da: - kadar je zdravilo EVICEL napršeno s pomočjo plina pod tlakom, mora biti ta plin ogljikov dioksid, saj večja topnost ogljikovega dioksida v krvi zmanjša tveganje za pojav embolije.
English: The vials can be stored at room temperature for up to 24 hours.
Slovenian: Viale lahko hranimo pri sobni temperaturi do 24 ur.
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.
Slovenian: Na voljo ni dovolj podatkov, da bi lahko ugotovili, ali obstajajo tveganja, ki so povezana z uporabo zdravila EVICEL med nosečnostjo ali v obdobju dojenja.
English: Manufacturers of these products also include steps in the processing of the blood and plasma that can inactivate or remove viruses.
Slovenian: Izdelovalci teh zdravil vključijo tudi stopnje priprave krvi in plazme, kjer se virusi inaktivirajo ali odstranijo.
English: If application of a single layer of EVICEL does not completely stop the bleeding, a second layer may be applied.
Slovenian: Če nanos enega sloja zdravila EVICEL krvavitve ne ustavi popolnoma, je mogoče nanesti drugi sloj.
English: For storage conditions after thawing of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po odtalitvi zdravila glejte poglavje 6.3.
English: Data are too limited to support the safety and effectiveness of EVICEL in children and adolescents.
Slovenian: Podatki so preveč omejeni, da bi lahko podpirali varnost in učinkovitost zdravila EVICEL pri otrocih in mladostnikih.
English: • Nearby areas should be protected to make sure that EVICEL is only applied onto the surface which is to be treated.
Slovenian: • Bližnje površine je treba zaščititi, da bi zagotovili, da je zdravilo EVICEL naneseno le na zdravljene površine.
English: Headache Hydrocephalus Subdural hygroma
Slovenian: Hidrocefalus Subduralni higrom
English: 2°C-8°C (refrigerator): vials thaw within 1 day,
Slovenian: 2 °C-8 °C (hladilnik): viale se odtalijo v 1 dnevu,
English: The amount of EVICEL that will be applied depends on the surface area of tissue to be treated during the operation.
Slovenian: Količina uporabljenega zdravila je odvisna od površine tkiva, zdravljenega med operacijskim posegom.
English: A non-interventional post-authorisation safety study was conducted which involved 300 patients undergoing vascular surgery during which EVICEL was used.
Slovenian: Po pridobitvi dovoljenja za promet je bila opravljena neintervencijska študija varnosti, ki je zajela 300 bolnikov po žilnem kirurškem posegu, med katerim je bilo uporabljeno zdravilo EVICEL.
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.
Slovenian: • Izobraževalni paket bo vseboval: o Povzetek glavnih značilnosti zdravila, o poglavje z naslovom »Naslednje informacije so na voljo samo zdravstvenemu osebju« v najnovejših Navodilih za uporabo, o gradivo za izobraževanje, namenjeno zdravstvenemu osebju
English: Do not refrigerate EVICEL once it has reached room temperature.
Slovenian: Zdravila EVICEL ne smete shraniti v hladilniku potem, ko je doseglo sobno temperaturo.
English: The application device should be stored at room temperature, separately from the fibrinogen and thrombin.
Slovenian: Aplikator shranjujte pri sobni temperaturi ločeno od raztopin fibrinogena in trombina.
English: • As with any product containing proteins, allergic-type hypersensitivity reactions are possible.
Slovenian: • Kot pri vseh zdravilih, ki vsebujejo beljakovine, so možne preobčutljivostne reakcije alergijskega tipa.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalca bioloških zdravilnih učinkovin
English: Therefore, the product should be administered to pregnant and breast-feeding women only if clearly needed.
Slovenian: Zato se sme zdravilo EVICEL uporabljati pri nosečnicah in doječih materah samo, kadar je to nedvomno potrebno.
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.
Slovenian: Vse koncentracije kombinacije TnBP in Tritona X100 so dale negativen rezultat tudi v testih za ugotavljanje mutagenosti za celice sesalcev, kromosomskih aberacij in indukcije mikronukleusa.
English: Factor XIIIa, which is activated from Factor XIII by thrombin, crosslinks fibrin.
Slovenian: Trombin aktivira faktor XIII v faktor XIIIa, ta pa navzkrižno poveže fibrin.
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.
Slovenian: Za nanašanje razpršila glejte poglavji 4.4 in 6.6, ki vsebujeta posebna priporočila v zvezi z zahtevanim tlakom in razdaljo od tkiva glede na kirurški poseg in dolžino konice aplikatorja.
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.
Slovenian: Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, so selekcija darovalcev, presejanje posameznih odvzetih enot in združene plazme za specifične označevalce okužbe in vključevanje učinkovitih proizvodnih stopenj za inaktivacijo/odstranitev virusov.
English: The instructions for use are also described in the healthcare professionals package leaflet part.
Slovenian: Navodila za uporabo so opisana tudi v poglavju Informacije za zdravstveno osebje v Navodilu za uporabo.
English: The following side effects which occurred during clinical studies were considered to be related to the use of EVICEL:
Slovenian: Za naslednje neželene učinke, ki so se pojavili med kliničnimi študijami, je bilo ocenjeno, da bi utegnili biti vzročno povezani z uporabo zdravila EVICEL:
English: An application device and appropriate accessory tips are supplied separately.
Slovenian: Ločeno so na voljo aplikator in ustrezni nastavki.
English: The use of EVICEL in patients undergoing radiotherapy within 7 days after surgery has not been evaluated.
Slovenian: Uporaba zdravila EVICEL pri bolnikih, ki so se sedem dni po posegu zdravili z radioterapijo, ni bila ovrednotena.
English: As with any protein product, allergic type hypersensitivity reactions are possible.
Slovenian: Kot pri vseh beljakovinskih zdravilih so možne preobčutljivostne reakcije alergijskega tipa.
English: The fibrinogen and thrombin components are stable at room temperature for up to 24 hours.
Slovenian: Sestavini fibrinogen in trombin sta pri sobni temperaturi stabilni do 24 ur.
English: POB 888, Kiryat Ono 5510801 Israel
Slovenian: Kiryat Ono 5510801
English: Do not use solutions that are cloudy or have deposits.
Slovenian: Ne uporabite raztopin, ki so motne ali imajo usedline.
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:
Slovenian: Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo v vsaki državi članici, kjer se zdravilo Evicel trži, zdravstveni delavci, ki uporabljajo zdravilo Evicel, prejeli izobraževalni paket, namenjen širjenju ozaveščenosti otveganju za življenjsko nevarno plinsko embolijo, če se zdravilo naprši nepravilno, in za zagotavljanje smernic za zmanjšanje tega tveganja:
English: The safety of fibrin sealants/haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Slovenian: Varnost uporabe fibrinskih lepil/hemostatikov pri ženskah med nosečnostjo ali dojenjem ni potrjena z nadzorovanimi kliničnimi preskušanji.
English: Fibrinogen is a concentrate of clottable protein and thrombin is an enzyme that causes clottable protein to coalesce.
Slovenian: Fibrinogen je koncentrat koagulacijske beljakovine, trombin pa encim, ki vpliva na koagulacijsko beljakovino tako, da ta tvori strdke.
English: Oedema peripheral
Slovenian: Periferni edem
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.
Slovenian: Komponenti fibrinogena in trombina sta stabilni pri sobni temperaturi do 24 ur, po vnosu v aplikator pa ju morate porabiti nemudoma.
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.
Slovenian: V kontroliranih kliničnih preskušanjih v žilni kirurgiji je bil volumen posameznega odmerka do 4 ml; pri lepljenju šivov za zapiranje dure so uporabljali odmerke do 8 ml, pri retroperitonealnih ali intraabdominalnih kirurških posegih pa je bil volumen posameznega odmerka do 10 ml.
English: Fax: + 32 2 746 30 01
Slovenian: Faks: + 32 2 746 30 01
English: Decreased haemoglobin
Slovenian: Znižan hemoglobin
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.
Slovenian: Ukrepi, ki se izvajajo, štejejo za učinkovite proti virusom z ovojnico, kot so HIV, virus hepatitisa C in virus hepatitisa B, ter proti virusu hepatitisa A, ki je brez ovojnice.
English: There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.
Slovenian: Obstaja teoretična možnost, da pri vas nastanejo protitelesa proti beljakovinam v zdravilu EVICEL, kar lahko moti strjevanje krvi.
English: Neurobehavioral observations for 14±1 days showed no abnormal findings.
Slovenian: Pri spremljanju nevrovedenjskih lastnosti v obdobju 14±1 dni niso opazili nenormalnosti.
English: Fibrin sealants/haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Slovenian: Fibrinska lepila/hemostatiki se presnavljajo na enak način kot endogeni fibrin - s fibrinolizo in fagocitozo.