FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Nenamerno intravaskularno injiciranje lahko povzroči trombembolični dogodek in diseminirano intravaskularno koagulacijo, prav tako pa obstaja tveganje za anafilaktično reakcijo (glejte poglavje
English: Raplixa may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).
Slovenian: Zdravilo Raplixa se lahko po izpostavljenosti raztopinam, ki vsebujejo alkohol, jod ali težke kovine (npr. antiseptične raztopine) denaturira.
English: Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.
Slovenian: Pretvorba fibrinogena v fibrin se zgodi s cepitvijo fibrinogena v fibrinske monomere in fibrinopeptide.
English: In clinical trials, smaller bleeding sites (< 10 cm²) used 0.5 g to 1 g on average.
Slovenian: V kliničnih preskušanjih so za manjše krvaveče predele (< 10 cm²) povprečno uporabili 0,5 g do 1 g. Za večje krvaveče predele so porabili 1 do 2 grama (10 - 100 cm²).
English: instructions for use
Slovenian: NAVODILA ZA UPORABO
English: Raplixa should not be administered during pregnancy and breast-feeding.
Slovenian: Zdravila Raplixa se ne sme uporabljati med nosečnostjo in dojenjem.
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 isolated cases in patients treated with fibrin sealants / haemostatics: these reactions have progressed to severe anaphylaxis.
Slovenian: Preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč občutek in zbadanje na mestu aplikacije, bronhospazem, mrazenje, vročinske oblive, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, stiskanje v prsih, mravljinčenje, bruhanje, sopenje) se lahko v posameznih redkih primerih pojavijo pri bolnikih, ki jih zdravimo s fibrinskimi lepili/hemostatiki: te reakcije so napredovale do hude anafilaksije.
English: Follow specific instructions for use of the absorbable gelatin sponge.
Slovenian: Upoštevajte specifična navodila za uporabo vpojne želatinske gobice.
English: Table 1: Required Dose of Raplixa Maximum Surface Area Direct Application from Vial
Slovenian: Preglednica 1: Potrebni odmerek zdravila Raplixa Največja površina nanosa Neposredni nanos iz viale
English: The outer aluminium foil sachet may be opened in a non-sterile operating area.
Slovenian: Zunanja vrečka iz aluminijaste folije se lahko odpre v nesterilnih pogojih.
English: In combination with a gelatin sponge, Raplixa is applied or sprayed onto cut tissue where it forms a layer that helps to stop bleeding.
Slovenian: V kombinaciji z želatinsko gobico se zdravilo Raplixa nanaša ali naprši na prerezano tkivo, kjer oblikuje plast, ki pomaga ustaviti krvavitev.
English: See section 4.
Slovenian: Glejte poglavje 4.4.
English: Children and adolescents Raplixa has not been evaluated for safety and effectiveness in children.
Slovenian: Otroci in mladostniki Varnosti in učinkovitosti zdravila Raplixa niso ocenili pri otrocih.
English: Before administration of Raplixa 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 uporabo zdravila Raplixa je treba predele okoli nameravanega predela aplikacije ustrezno zaščititi (prekriti), da se prepreči zlepljenje tkiva na neželenih predelih.
English: If you experience any symptoms such as vomiting with blood, blood in your stool, blood in your draining tube from your abdomen, swelling or skin discolouration in your extremities, chest pain and shortness of breath, and/or any other symptoms related to your surgery, please contact your doctor or surgeon immediately.
Slovenian: Če se pojavijo kateri koli simptomi, kot so bruhanje s krvjo, kri v stolici, kri v drenažni cevki iz trebuha, oteklina ali obarvanje kože okončin, bolečina v prsnem košu in zasoplost in/ali kateri koli drugi simptomi, povezani s posegom, se takoj posvetujte z zdravnikom ali kirurgom.
English: The following side effects have also been reported: Common side effects (may affect up to 1 in 10 people):
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: The required dose of Raplixa based on the size of the bleeding surface area to be treated is shown in the table below:
Slovenian: Potrebni odmerki zdravila Raplixa na podlagi velikosti krvaveče površine, ki bo zdravljena, so prikazani v spodnji preglednici:
English: The measures taken are considered effective for enveloped viruses such human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV).
Slovenian: Izvajani ukrepi veljajo za učinkovite pri virusih z ovojnico kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV).
English: It is strongly recommended that every time you receive a dose of Raplixa the name and batch number of the medicine are recorded in order to maintain a record of the batches used.
Slovenian: Močno se priporoča, da se po vsaki uporabi odmerka zdravila Raplixa zabeleži ime in številka serije zdravila, da se vzdržuje evidenca uporabljenih serij.
English: The amount of Raplixa that will be applied depends on the surface area to be treated during the operation and the severity of the blood loss.
Slovenian: Količina uporabljenega zdravila Raplixa je odvisna od površine, zdravljene med operacijskim posegom, in resnosti izgube krvi.
English: For epilesional use Read the package leaflet before use.
Slovenian: Epilezijska uporaba Pred uporabo preberite priloženo navodilo.
English: Gelatin sponges are CE marked and separately supplied and packed (see instructions for use for the specific gelatin sponge selected for use).
Slovenian: Želatinske gobice imajo oznako CE in se prodajajo in pakirajo posebej (glejte navodilo za uporabo za specifično želatinsko gobico, ki ste jo izbrali za uporabo).
English: The fibrin monomers aggregate and form a fibrin clot.
Slovenian: Fibrinski monomeri se združujejo in tvorijo fibrinski strdek.
English: • Use of the Raplixa spray device only in open surgery, not endoscopic surgery
Slovenian: • pripomoček Raplixa Spray se lahko uporablja le pri odprti operaciji in ne za endoskopske
English: It is strongly recommended that every time Raplixa 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.
Slovenian: Močno se priporoča, da se ob vsaki uporabi zdravila Raplixa pri bolniku zabeleži ime in številka serije zdravila, da se ohranja povezava med bolnikom in serijo zdravila.
English: The required dose of Raplixa, can vary based on the size of the area to be treated.
Slovenian: Potrebni odmerek zdravila Raplixa se lahko razlikuje glede na velikost zdravljenega predela.
English: The surgeon treating you will administer Raplixa during surgery.
Slovenian: Kirurg, ki vas zdravi, bo uporabil zdravilo Raplixa med kirurškim posegom.
English: - The other ingredients are trehalose, calcium chloride, albumin, sodium chloride, sodium citrate,
Slovenian: - Druge sestavine zdravila so trehaloza, kalcijev klorid, albumin, natrijev klorid, natrijev citrat,
English: • Use of Raplixa has only been shown to arrest bleeding in surgery visualized through the incision (open surgery).
Slovenian: • Dokazano je bilo, da uporaba zdravila Raplixa krvavitev ustavi le pri operaciji z vizualizacijo skozi incizijo (odprti poseg).
English: • When Raplixa is applied during surgery, the surgeon must ensure that it is only applied onto the surface of tissue.
Slovenian: • Pri nanosu zdravila Raplixa med operativnim posegom se mora kirurg prepričati, da zdravilo nanaša le na površino tkiva.
English: The measures taken in the manufacture of fibrinogen and thrombin are considered effective for lipid coated viruses such as HIV (human immunodeficiency virus), hepatitis B virus and hepatitis C virus.
Slovenian: Ukrepi, ki se izvajajo pri izdelavi raztopin fibrinogena in trombina, se štejejo za učinkovite proti virusom z lipidno ovojnico, kot so humani virus imunske pomanjkljivosti (HIV), virus hepatitisa B in virus hepatitisa.
English: Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie
Slovenian: Faks: + 386 (0)1 434 76 46 e-pošta: farmakovigilanca@kclj.si
English: If you experience an allergic reaction you might have one or more of the following symptoms: skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting or wheezing.
Slovenian: Če se pri vas pojavi alergijska reakcija, boste morda opazili enega ali več od naslednjih simptomov: kožni osip, izpuščaj ali koprivnica, stiskanje v prsih, mrazenje, vročinske oblive, glavobol, nizek krvni tlak, letargijo, siljenje na bruhanje, nemir, zvišan srčni utrip, mravljinčenje, bruhanje ali sopenje.
English: The active ingredient fibrinogen is a concentrate of clottable protein; the other active ingredient thrombin is an enzyme that causes clottable protein to coalesce to form a plug.
Slovenian: Zdravilna učinkovina, fibrinogen, je koncentrat koagulacijske beljakovin; druga zdravilna učinkovina, trombin, pa je encim, ki koagulacijsko beljakovino združi v strdek, ki ustavi krvavitev.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
English: Raplixa must not be injected into blood vessels because it would cause clots which could be fatal.
Slovenian: Zdravila Raplixa se ne sme injicirati v krvne žile, ker lahko povzroči tvorbo strdkov, ki lahko povzročijo smrt.
English: The product should only be administered according to the instructions and with the devices recommended for this product.
Slovenian: Zdravilo lahko nanašate v skladu z navodili in s pripomočkom, priporočenim za to zdravilo.
English: The product should not be administered to pregnant and breast-feeding women.
Slovenian: Zdravila se ne sme uporabljati pri nosečnicah ali ženskah, ki dojijo.
English: When using accessory nozzles with this product, the instructions for use of the nozzles should be followed.
Slovenian: Pri uporabi dodatnih šob s tem zdravilom je treba upoštevati navodila za uporabo teh šob.
English: Raplixa is applied during surgical operations, to reduce bleeding and oozing during and after the operation in adults.
Slovenian: Zdravilo Raplixa se uporablja med kirurškim posegom za zmanjšanje krvavitve in izcejanja med posegom in po njem pri odraslih.
English: Parvovirus B19 may be serious for pregnant women (fetal infection) and of individuals with immunodeficiency or increased erythropoiesis (e.g. Haemolytic anaemia).
Slovenian: Okužbe s parvovirusom B19 so lahko resne pri nosečnicah (okužba ploda) in za posameznike z imunsko pomanjkljivostjo ali večjo eritropoezo (npr. hemolitična anemija).
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (for example sickle cell disease or haemolytic anaemia).
Slovenian: Okužba s parvovirusom B19 je lahko resna pri nosečnicah (okužba ploda) in posameznikih z oslabljenim delovanjem imunskega sistema ali tistih, ki imajo določene vrste anemij (npr. srpastocelično anemijo ali hemolitično anemijo).
English: - If you get any of the side effects talk to your doctor, pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: When applying Raplixa using the recommended spray device, your surgeon must be sure to use a pressure and a distance from tissue within the range recommended by the manufacturer as follows:
Slovenian: Pri nanosu zdravila Raplixa s priporočenim pršilnikom mora kirurg uporabljati tlak in razdaljo od tkiva v razponu, ki ga priporoča proizvajalec, kot sledi:
English: Raplixa is intended for epilesional use only.
Slovenian: Zdravilo Raplixa je izključno za epilezijsko uporabo.
English: The Raplixa spray device (RaplixaSpray) should only be used if it is possible to accurately judge the spray distance.
Slovenian: Pripomoček za pršenje zdravila Raplixa (RaplixaSpray) naj se uporablja le, če je možno natančno oceniti razdaljo pršenja.
English: The initial amount 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 with a thin layer of Raplixa which is then covered by an absorbable gelatin sponge (saline-wetted).
Slovenian: Začetna količina zdravila, ki se aplicira na izbrano anatomsko mesto ali ciljno površino, mora zadoščati za prekritje celotnega nameravanega predela aplikacije s tanko plastjo zdravila Raplixa, ki se nato prekrije z vpojno želatinsko gobico (namočeno v fiziološko raztopino).
English: When spraying Raplixa, safety will be monitored because of the possibility of occurrence of air or gas embolism.
Slovenian: Pri pršenju zdravila Raplixa se spremlja varnost, saj se lahko pojavi zračna ali plinska embolija.
English: Raplixa Package Size
Slovenian: Velikost pakiranja zdravila Raplixa
English: The composition of Raplixa per gram powder is provided in Table 1.
Slovenian: Sestava zdravila Raplixa na gram praška je razvidna iz preglednice 1.
English: This event appears to be related to the use of spray devices at higher than recommended pressures and/or in close proximity to the tissue surface.
Slovenian: Kaže, da je ta dogodek povezan z uporabo pršilnikov s tlakom, ki je višji od priporočenega, in/ali preblizu površine tkiva.
English: Store Raplixa powder vials at 2 °C to 25 °C.
Slovenian: Viale s praškom zdravila Raplixa shranjujte pri temperature med 2 °C in 25 °C.
English: Higher dosages up to 4g (including re-application and treatment of more than a single bleeding site) may be needed.
Slovenian: Velikost pakiranja zdravila Raplixa 0,5 g 1 g Morda bodo potrebni večji odmerki do 4 g (vključno s ponovnim nanosom in zdravljenjem več mest krvavitev).
English: The gelatin sponges should be handled and used according to the manufacturer's instructions in the package insert that accompanies the gelatin sponge.
Slovenian: Želatinske gobice je treba uporabljati v skladu z navodilom za uporabo proizvajalca, ki je priloženo želatinski gobici.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Slovenian: Kljub tem ukrepom možnosti prenosa okužb pri zdravilih, pripravljenih iz humane krvi ali plazme, ni mogoče povsem izključiti.
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.
Slovenian: Kaže, da je ta dogodek povezan z uporabo pršil s tlakom, ki je višji od priporočenega, in/ali preblizu površine tkiva.
English: Animal reproduction studies have not been conducted with Raplixa.
Slovenian: Študije vpliva na sposobnost razmnoževanja z zdravilom Raplixa na živalih niso bile opravljene.
English: Signs of hypersensitivity reactions may include hives, generalized urticarial, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Znaki preobčutljivostne reakcije lahko vključujejo koprivnico, generalizirano urtikarijo, tiščanje v prsih, sopenje, hipotenzijo in anafilakso.
English: Spray application of Raplixa must not be used in endoscopic or laparoscopic procedures.
Slovenian: Aplikacija zdravila Raplixa s pršenjem ni dovoljena pri endoskopskih ali laparoskopskih posegih.
English: One of the following methods of application of Raplixa may be used based on the type of surgery, location and size and severity of the bleeding:
Slovenian: Zdravilo Raplixa se lahko nanaša na katerega od spodaj navedenih načinov, odvisno od vrste kirurškega posega, mesta posega in velikosti ter resnosti krvavitve:
English: Once the vial is opened, use within 2 hours.
Slovenian: Po odprtju vialo uporabite v 2 urah.
English: Application must be within 2 hours after connecting the vial to the device.
Slovenian: Zdravilo je treba aplicirati v 2 urah od spojitve viale s pripomočkom.
English: When using the RaplixaSpray device
Slovenian: Pri uporabi pršila RaplixaSpray
English: - The active substances in Raplixa are human plasma derived fibrinogen and human thrombin.
Slovenian: Zdravilni učinkovini v zdravilu Raplixa sta fibrinogen iz humane plazme in humani trombin.
English: • Which regulator(s) should be used, in line with manufacturer recommendations and the SmPC
Slovenian: • regulatorji, ki jih je treba uporabiti v skladu s priporočili proizvajalca in z navodilom za uporabo v povzetku glavnih značilnosti zdravila
English: Each gram of powder contains 79 mg human fibrinogen and 726 IU human thrombin.
Slovenian: En gram praška vsebuje 79 mg humanega fibrinogena in 726 i.e. humanega trombina.
English: Raplixa has been studied in patients undergoing spinal surgery, vascular surgery, soft tissue surgery and hepatic resection.
Slovenian: Zdravilo Raplixa so preučili pri bolnikih s kirurškim posegom na hrbtenici, posegu na žilju, posegu na mehkem tkivu in z resekcijo jeter.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Slovenian: Redko se lahko razvijejo protitelesa proti sestavinam fibrinskih lepil/hemostatskih zdravil.
English: Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, Ireland
Slovenian: Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park, Cruiserath, Blanchardstown, Dublin 15, Irska
English: In clinical trials a thin layer of Raplixa produced doses that typically ranged from 0.3 to 2 g. For some procedures eg.
Slovenian: V kliničnih preskušanjih je bil odmerek s tanko plastjo zdravila Raplixa običajno med 0,3 do 2 g. Za nekatere postopke, npr. resekcijo jeter, bodo morda potrebne večje količine.
English: How to Use Raplixa
Slovenian: Kako uporabljati zdravilo Raplixa
English: When applying Raplixa using the Raplixa spray device, the pressure should be within the range recommended by ProFibrix.
Slovenian: Pri nanosu zdravila Raplixa s pripomočkom RaplixaSpray mora biti tlak v razponu, ki ga priporoča ProFibrix.
English: Intravascular application
Slovenian: Intravaskularna uporaba
English: 2 g human fibrinogen 79 mg/g human thrombin 726 IU/g
Slovenian: 2 g humani fibrinogen 79 mg/g humani trombin 726 i.e./g
English: The use of Raplixa is restricted to experienced surgeons who have been trained in the use of Raplixa.
Slovenian: Zdravilo Raplixa lahko uporabljajo le izkušeni kirurgi, ki so se izobraževali za uporabo zdravila Raplixa.
English: Human fibrinogen 79 mg/g Human thrombin 726 IU/g
Slovenian: Humani fibrinogen 79 mg/g Humani trombin 726 i.e./g
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: This may be removed and the flexible nozzle can be attached depending on the intended use and surgeon preference.
Slovenian: To lahko odstranite in priključite gibljivo šobo, odvisno od namena uporabe in želja kirurga.
English: Prior to applying Raplixa the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Slovenian: Pred aplikacijo zdravila Raplixa je treba površino rane osušiti s standardnimi tehnikami (npr. z uporabo kompres, tamponov ali sesalnih naprav med postopkom).
English: To avoid the risk of potentially life-threatening air embolism, it is recommended that Raplixa should be sprayed using pressurised CO2.
Slovenian: Da se prepreči potencialno življenjsko nevarna zračna embolija, se priporoča pršenje zdravila Raplixa s pomočjo stisnjenega CO2.
English: The measures may be of limited value against non- enveloped viruses such as HAV and parvovirus B19.
Slovenian: Ukrepi, ki se izvajajo, so morda manj učinkoviti proti virusom brez ovojnice, kot sta virus hepatitisa A in parvovirus B19.
English: Raplixa is a pre-mixed, ready to use blend of thrombin and fibrinogen supplied as a ready to use drypowder fibrin sealant in a glass vial containing 0.5 g, 1 g or 2 g of Raplixa that is applied onto the surgical bleeding site directly from the vial or using the RaplixaSpray device.
Slovenian: Zdravilo Raplixa je vnaprej zmešana mešanica trombina in fibrinogena, na voljo kot za uporabo pripravljeno fibrinsko lepilo v obliki suhega praška v stekleni viali, ki vsebuje 0,5 g, 1 g ali 2 g zdravila Raplixa, ki se nanese na mesto kirurške krvavitve neposredno iz viale ali z uporabo pripomočka RaplixaSpray.
English: • Requirement to dry the wound using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) prior to using the product
Slovenian: • zahtevano je, da je treba pred uporabo zdravila rano osušiti s standardnimi tehnikami (npr. z uporabo kompres, tamponov ali uporabo sesalnih naprav med postopkom)
English: Application of the product must be individualised by the treating surgeon.
Slovenian: Lečeči kirurg aplikacijo zdravila prilagodi posamezniku.
English: The Raplixa should be stored at controlled, ambient room temperature.
Slovenian: Zdravilo Raplixa shranjujte pri nadzorovani sobni temperaturi okolice.
English: Raplixa must not be used as a glue for the fixation of patches.
Slovenian: Zdravilo Raplixa se ne sme uporabljati kot lepilo za pritrditev obližev.
English: As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Slovenian: V nadaljnjem procesu celjenja rane plazmin inducira povečano fibrinolitično aktivnost in razgradnjo fibrina v fibrinske produkte
English: When using a moistened gelatin sponge, a thin layer of Raplixa should be applied to the sponge immediately prior to application to the bleeding site.
Slovenian: Pri uporabi navlažene želatinske gobice je treba na gobico tik pred aplikacijo na mesto krvavitve nanesti tanko plast zdravila Raplixa.
English: Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: Odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: There are three methods of application: direct application of Raplixa to the bleeding tissue followed by application of the gelatin sponge or application of Raplixa first to a gelatin sponge and application of the sponge to the bleeding tissue; or application of the Raplixa powder by using the RaplixaSpray device followed by the application of the gelatin sponge.
Slovenian: Obstajajo trije načini nanosa: neposredni nanos zdravila Raplixa na krvaveče tkivo, ki mu sledi uporaba želatinske gobice ali nanos zdravila Raplixa na želatinsko gobico, nato pa nanos gobice na krvaveče tkivo ali nanos praška zdravila Raplixa s pripomočkom RaplixaSpray, nato pa nanos želatinske gobice.
English: What Raplixa contains
Slovenian: Kaj vsebuje zdravilo Raplixa
English: Spray application of Raplixa should only be used if it is possible to accurately judge the spray distance.
Slovenian: Zdravilo Raplixa se lahko nanaša s pršilom le, če je možno natančno oceniti razdaljo pršenja.