FrancophonIA/ELRC3.0 huggingface dataset:
English: The first controlled clinical trial investigating tissue sealing in lung surgery failed to document superiority over standard treatment measured by air leakage due to the inclusion of a large group of patients (53%) without air leakage.
Slovenian: V prvem nadzorovanem kliničnem preskušanju, v katerem so raziskovali tesnjenje tkiva v pljučni kirurgiji, prednosti pred standardno obliko zdravljenja, vrednoteno na osnovi uhajanja zraka niso dokazali, saj je bil v študijo vključen velik delež bolnikov (53 %) brez uhajanja zraka.
English: Do not use TachoSil - if you are allergic (hypersensitive) to human fibrinogen, human thrombin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila TachoSil - če ste alergični na humani fibrinogen, humani trombin ali katero koli sestavino tega zdravila
English: In the integrated analyses, 997 patients were treated with TachoSil and 984 patients were treated with comparator treatment.
Slovenian: Združena analiza vključuje podatke, pridobljene pri 997 bolnikih, zdravljenih z zdravilom TachoSil, in 984 bolnikih, zdravljenih s primerjalno obliko zdravljenja.
English: Takeda Austria GmbH St. Peter Strasse 25 A-4020 Linz Austria
Slovenian: Takeda Austria GmbH St. Peter Strasse 25 A-4020 Linz Avstrija
English: In the body TachoSil will dissolve and disappear completely.
Slovenian: Zdravilo TachoSil nato v telesu postopoma razpade in popolnoma izgine.
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 virus/infections.
Slovenian: Ti ukrepi obsegajo skrbno izbiro darovalcev krvi in plazme za izključitev možnih prenašalcev okužb ter testiranje posameznih darovanj in zbirov plazme na znake prisotnih virusov/okužb.
English: The degradation was associated with infiltration of granulocytes and formation of resorptive granulation tissue encapsulating the degraded remnants of TachoSil.
Slovenian: Razgradnja je bila povezana z infiltracijo granulocitov in tvorbo resorpcijskega granulacijskega tkiva, ki je obdalo ostanke zdravila TachoSil v razgradnji.
English: This means that the TachoSil sticks to the tissue surface, the blood coagulates (local haemostasis) and the tissue is sealed.
Slovenian: To pomeni, da se zdravilo TachoSil prime na površino tkiva, kri koagulira (lokalna hemostaza) in tkivo se zapre.
English: In isolated cases, these reactions may progress to severe anaphylaxis.
Slovenian: V posameznih primerih se lahko te reakcije stopnjujejo do hude anafilaksije.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
English: Pre-moisten the flat TachoSil matrix in saline solution and place it on the wound immediately (if the wound is completely wetted by blood and other fluids, there is no need to moisten the matrix before application).
Slovenian: Zdravilo TachoSil v obliki ploščatega matriksa predhodno navlažite s fiziološko raztopino in ga nato takoj namestite na rano (če je rana povsem vlažna zaradi krvi ali drugih tekočin, matriksa pred namestitvijo ni treba navlažiti).
English: TachoSil must not be applied intravascularly.
Slovenian: Zdravila TachoSil se ne sme uporabljati intravaskularno.
English: TachoSil is used during surgery to stop local bleeding (haemostasis) and to seal tissue surfaces on internal organs.
Slovenian: Zdravilo TachoSil uporabljamo med kirurškimi posegi za zaustavljanje lokalne krvavitve (hemostaza) in za zatesnitev tkivnih površin na notranjih organih.
English: How does TachoSil work?
Slovenian: Kako deluje zdravilo TachoSil?
English: Similar to comparable products or thrombin solutions, the sealant may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).
Slovenian: Kot primerljiva zdravila ali raztopine trombina se lahko tudi to lepilo za zapiranje ran denaturira, če pride v stik z raztopinami, ki vsebujejo alkohol, jod ali težke kovine (npr. antiseptične raztopine).
English: Instructions Use TachoSil under sterile conditions only.
Slovenian: Navodila Zdravilo TachoSil uporabljajte le v sterilnih pogojih.
English: Alternatively, e.g. in case of stronger bleeding, TachoSil may be applied without pre-moistening, while also pressing gently to the wound for 3-5 minutes.
Slovenian: Alternativno, npr. pri močnejši krvavitvi, lahko zdravilo TachoSil namestite brez predhodne navlažitve in ga nato nežno pritiskate na rano od 3 do 5 minut.
English: In neurosurgery, TachoSil should be applied on top of the primary dura closure.
Slovenian: V nevrokirurgiji je treba zdravilo TachoSil namestiti na površino primarnega zaprtja dure.
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: Takšne reakcije se lahko še posebej pojavijo pri večkratni uporabi zdravila, ali bolnikih, za katere je znano, da so preobčutljivi na sestavine zdravila.
English: - The active substances are human fibrinogen (5.5 mg per cm 2) and human thrombin (2.0 IU per cm - The other ingredients are equine collagen, human albumin, riboflavin (E101), sodium chloride, sodium citrate (E331) and L-arginine-hydrochloride.
Slovenian: - Zdravilni učinkovini sta humani fibrinogen (5,5 mg na cm 2) in humani trombin (2,0 i.e. na cm - Druge sestavine zdravila so konjski kolagen, humani albumin, riboflavin (E101), natrijev klorid, natrijev citrat (E331) in L-argininijev klorid.
English: Tissue sealing in lung surgery was investigated in two controlled trials in patients undergoing lung surgery.
Slovenian: Tesnjenje tkiv pri kirurških posegih na pljučih so raziskali z dvema nadzorovanima študijama pri bolnikih, ki so bili operirani na pljučih.
English: However, the second study investigating tissue sealing in 299 patients (149 TachoSil, 150 standard surgical treatment) with demonstrated intraoperative air leakage showed the superiority of TachoSil compared to standard treatment.
Slovenian: Druga študija o tesnjenju tkiv, izvedena pri 299 bolnikih (149 zdravilo TachoSil, 150 standardno kirurško zdravljenje) z ugotovljenim intraoperativnim uhajanjem zraka pa je pokazala superiornost zdravila TachoSil v primerjavi s standardno obliko zdravljenja.
English: In animal studies, TachoSil biodegrades after administration to a wound surface with few remnants left after 13 weeks.
Slovenian: V študijah na živalih se je zdravilo TachoSil po nanosu na površino rane biološko razgradilo in po 13 tednih je bilo prisotnih le malo ostankov.
English: A clinical study has shown that some patients produced antibodies against the components of TachoSil, however, no side effects were reported resulting from the development of these antibodies.
Slovenian: Klinična študija je pokazala, da so se pri nekaterih bolnikih razvila protitelesa proti sestavinam zdravila TachoSil, vendar pa zaradi razvoja protiteles niso poročali o pojavu neželenih učinkov.
English: In clinical trials, the individual dosages have typically ranged from 1-3 units (9.5 cm x 4.8 cm); application of up to 10 units has been reported.
Slovenian: V kliničnih preskušanjih so običajno uporabili od 1 do 3 enote zdravila (9,5 cm x 4,8 cm), poročali pa so tudi o uporabi do 10 enot.
English: TachoSil is for local use only and should not be applied inside a blood vessel.
Slovenian: Zdravilo TachoSil je namenjeno le za lokalno uporabo in se ga ne sme vstaviti v žilo.
English: For minimally invasive surgery, the pre-rolled matrix can be un-rolled with instruments at the site of application.
Slovenian: Pri minimalno invazivnem kirurškem posegu lahko matriks v že pripravljenem zvitku s pomočjo instrumentov odvijete na mestu namestitve.
English: In contact with physiological fluids, e.g. blood, lymph or physiological saline solution the components of the coating dissolve and partly diffuse into the wound surface.
Slovenian: V stiku s fiziološkimi tekočinami, npr. s krvjo, z limfo ali s fiziološko raztopino, se sestavine nanosa raztopijo in delno razporedijo po površini rane.
English: Clinical studies demonstrating haemostasis were conducted in a total of 240 patients (119 TachoSil, 121 argon beamer) undergoing partial liver resection surgery and 185 patients (92 TachoSil, 93 standard surgical treatment) undergoing surgical resection of superficial renal tumour.
Slovenian: V kliničnih študijah za prikaz hemostaze so spremljali skupno 240 bolnikov (119 zdravilo TachoSil, 121 argonska plazemska koagulacija), pri katerih so opravili delno resekcijo jeter, in 185 bolnikov (92 zdravilo TachoSil, 93 standardno kirurško zdravljenje), pri katerih so opravili kirurško resekcijo površinskega ledvičnega tumorja.
English: TachoSil is intended for epilesional use only.
Slovenian: Zdravilo TachoSil je namenjeno samo za epilezijsko uporabo.
English: The quantity of TachoSil used depends on the size of the wound.
Slovenian: Količina uporabljenega zdravila TachoSil je odvisna od velikosti rane.
English: TachoSil is not recommended for use in children below age 18 years due to insufficient data on safety and efficacy.
Slovenian: Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba zdravila TachoSil pri otrocih, mlajših od 18 let, ni priporočljiva.
English: Two subjects have been re-exposed in a clinical trial and have not reported any immune-mediated adverse events; however, their antibody status to collagen or fibrinogen is unknown.
Slovenian: Pri teh dveh bolnikih niso poročali o nobenem imunsko pogojenem neželenem učinku, vendar pa njun protitelesni status proti kolagenu ali fibrinogenu ni bil znan.
English: The active side of the matrix, which is coated with fibrinogen and thrombin, is marked by a yellow colour.
Slovenian: Učinkovita stran matriksa, ki je obložena s fibrinogenom in trombinom, je označena z rumeno barvo.
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Slovenian: Okužba s parvovirusom B19 lahko resno ogroža nosečnice (okužba ploda) in posameznike z imunsko pomanjkljivostjo ali povečano eritropoezo (npr. hemolitična anemija).
English: • to use TachoSil soon after opening the outer aluminium cover.
Slovenian: • da se zdravilo TachoSil uporabi kmalu po odprtju zunanje aluminijaste ovojnine.
English: A further controlled study in 119 patients (62 TachoSil, 57 haemostatic fleece) demonstrated sealing, haemostasis and suture support in patients undergoing cardiovascular surgery.
Slovenian: Nadaljnja nadzorovana študija pri 119 bolnikih (62 zdravilo TachoSil, 57 hemostatska krpica) je pokazala tesnjenje, hemostazo in podporo šivom pri bolnikih s srčnožilnimi kirurškimi posegi.
English: Complete degradation of TachoSil was seen in some animals 12 months after its administration to a liver wound, whereas small remnants were still observed in others.
Slovenian: 12 mesecev po uporabi zdravila TachoSil na rani v jetrih so pri nekaterih živalih ugotovili popolno razgradnjo zdravila, medtem ko so pri drugih živalih še vedno opažali manjše ostanke.
English: Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, gloves or adjacent tissues covered with blood.
Slovenian: Zaradi močne afinitete kolagena do krvi se lahko zdravilo TachoSil prime tudi na kirurške instrumente, rokavice ali sosednja tkiva, na katerih je kri.
English: How to use TachoSil
Slovenian: Kako uporabljati zdravilo TachoSil
English: However, in a clinical trial with TachoSil in hepatic surgery, in which patients were investigated for the development of antibodies, 26% of the 96 patients tested and treated with TachoSil developed antibodies to equine collagen.
Slovenian: V kliničnem preskušanju uporabe zdravila TachoSil v jetrni kirurgiji, v katerem so raziskovali razvoj protiteles, so o razvoju protiteles proti konjskemu kolagenu poročali pri 26 % od 96 testiranih bolnikov, ki so se zdravili z zdravilom TachoSil.
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 pa pri uporabi zdravil, pripravljenih iz humane krvi ali plazme, možnosti prenosa okužb ni mogoče povsem izključiti.
English: During the following time TachoSil will dissolve and disappear.
Slovenian: Zdravilo TachoSil bo nato sčasoma razpadlo in izginilo.
English: Place the yellow, active side of TachoSil against the wound.
Slovenian: Na rano namestite rumeno, učinkovito stran zdravila TachoSil.
English: You may suffer hives, or a rash similar to nettle rash, chest discomfort or tightness, wheezing or low blood pressure.
Slovenian: Simptomi lahko vključujejo koprivnico ali izpuščaj, podoben koprivnici, tiščanje ali nelagodje v prsnem košu, piskajoče dihanje ali nizek krvni tlak.
English: TachoSil contains fibrinogen and thrombin as a dried coating on the surface of a collagen matrix.
Slovenian: Zdravilo TachoSil vsebuje fibrinogen in trombin kot sušen nanos na površini kolagenskega matriksa.
English: Such substances should be removed to the greatest possible extent before applying the sealant.
Slovenian: Pred namestitvijo lepila za zapiranje ran je treba takšne snovi v največji možni meri odstraniti.
English: EU/1/04/277/001 1 matrix of 9.5 cm x 4.8 cm EU/1/04/277/002 2 matrices of 4.8 cm x 4.8 cm EU/1/04/277/003 1 matrix of 3.0 cm x 2.5 cm EU/1/04/277/004 5 matrices of 3.0 cm x 2.5 cm EU/1/04/277/005 1 pre-rolled matrix of 4.8 cm x 4.8 cm
Slovenian: EU/1/04/277/001 1 matriks velikosti 9,5 cm x 4,8 cm EU/1/04/277/002 2 matriksa velikosti 4,8 cm x 4,8 cm EU/1/04/277/003 1 matriks velikosti 3,0 cm x 2,5 cm EU/1/04/277/004 5 matriksov velikosti 3,0 cm x 2,5 cm EU/1/04/277/005 1 matriks v že pripravljenem zvitku velikosti 4,8 cm x 4,8 cm
English: TachoSil comes ready to use in sterile packages and must be handled accordingly.
Slovenian: Zdravilo TachoSil je že pripravljeno za uporabo in je na voljo v sterilni ovojnini, zato morate z njim ustrezno ravnati.
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.
Slovenian: Pri bolnikih, ki se zdravijo s fibrinskimi/hemostatičnimi sredstvi za zapiranje ran, se v redkih primerih lahko pojavijo preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč občutek in zbadanje na mestu aplikacije, bronhospazem, mrzlico, zardevanje, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, tiščanje v prsnem košu, mravljinčenje, bruhanje in/ali piskajoče dihanje).
English: When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to the patients.
Slovenian: Pri pripravi zdravil iz humane krvi ali plazme izdelovalec upošteva določene ukrepe za preprečevanje prenosa okužb na bolnika.
English: Equine collagen, human albumin, riboflavine (E101), sodium chloride, sodium citrate (E331), L-arginine-hydrochloride
Slovenian: Konjski kolagen, humani albumin, riboflavin (E101), natrijev klorid, natrijev citrat (E331), L-argininijev klorid
English: Parvovirus B19 infection may be serious for pregnant woman (foetal infection) and for individuals whose immune system is depressed or who have some types of anaemia, (e.g. sickle cell disease or haemolytic anaemia).
Slovenian: Okužba s parvovirusom B19 lahko resno ogroža nosečnice (okužba plodu) in posameznike z oslabljenim imunskim sistemom ali nekaterimi vrstami anemije (npr. srpastocelično anemijo ali hemolitično anemijo).
English: The active side of TachoSil should be applied so that it extends 1-2 cm beyond the margins of the wound.
Slovenian: Učinkovito stran zdravila TachoSil namestite tako, da sega od 1 do 2 cm preko robov rane.
English: Thromboembolic complications may occur if the preparation is applied intravascularly (see section 4.4).
Slovenian: Če se zdravilo uporabi intravaskularno, se lahko pojavijo trombembolični zapleti (glejte poglavje 4.4).
English: What TachoSil looks like and contents of the pack
Slovenian: Izgled zdravila TachoSil in vsebina pakiranja
English: The numbers of subjects experiencing an efficacy outcome event were 25 (6.9%) and 30 (8.2%) for TachoSil and current practice treated patients, respectively, providing an Odds Ratio of 0.82 (95% CI: 0.47, 1.43).
Slovenian: Pri uporabi zdravila TachoSil je bil uspešen izid zdravljenja zabeležen pri 25 bolnikih (6,9 %), pri uporabi obstoječe prakse zdravljenja pa pri 30 bolnikih (8,2 %), kar daje razmerje obetov 0,82 (95 % interval zaupanja: 0,47; 1,43), vendar pa 95 % interval zaupanja rezultata razmerja obetov kaže, da je učinkovitost zdravila TachoSil podobna učinkovitosti obstoječe prakse.
English: What is TachoSil used for?
Slovenian: Za kaj uporabljamo zdravilo TachoSil?
English: One patient developed antibodies to human fibrinogen.
Slovenian: Protitelesa proti humanemu fibrinogenu so se razvila pri enem bolniku.
English: The doctor treating you will apply TachoSil during surgery.
Slovenian: Zdravilo TachoSil vam bo namestil kirurg med kirurškim posegom.
English: As with any protein-containing product, allergic type hypersensitivity reactions are possible.
Slovenian: Kot pri uporabi drugih zdravil, ki vsebujejo beljakovine, se tudi pri uporabi tega zdravila lahko pojavijo alergijske preobčutljivostne reakcije.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Slovenian: Kljub temu pa pri uporabi zdravil, pripravljenih iz humane krvi ali plazme, možnosti prenosa povzročiteljev okužb ni mogoče povsem izključiti.
English: Therefore, TachoSil should be administered to pregnant and breastfeeding women only if clearly needed.
Slovenian: Zdravilo TachoSil se lahko pri nosečnicah ali doječih materah uporablja le, če je to nujno potrebno.
English: Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Slovenian: Znaki preobčutljivostnih reakcij vključujejo koprivnico, generalizirano urtikarijo, stiskanje v prsnem košu, piskajoče dihanje, hipotenzijo in anafilaksijo.
English: TachoSil was found to be well tolerated and safe for use as an adjunct to dura mater closure in neurosurgery.
Slovenian: Bolniki so zdravilo TachoSil dobro prenašali, njegova uporaba kot pomoč pri zapiranju dure mater v nevrokirurgiji pa je bila varna.
English: Each matrix contains per cm Human fibrinogen 5.5 mg Human thrombin 2.0 IU
Slovenian: En matriks na cm vsebuje humani fibrinogen 5,5 mg humani trombin 2,0 i.e.
English: The blister is packed in an aluminium-bonded foil sachet with a desiccant bag included and packed in a folding carton.
Slovenian: Pretisni omot je pakiran v vrečico iz aluminijaste folije skupaj s sušilnim sredstvom in vstavljen v škatlo.
English: ALUMINIUM-BONDED FOIL SACHET
Slovenian: VREČICA IZ ALUMINIJASTE FOLIJE
English: To make sure that TachoSil does not cling to the moistened glove or swab, and loosens itself from the wound, TachoSil can be held down at one end e.g. by using a pair of forceps.
Slovenian: Da se zdravilo TachoSil ne bi prijelo na navlažene rokavice ali blazinico in zato odstopilo z rane, ga lahko na enem koncu fiksirate na mestu, npr. s prijemalko.
English: TachoSil is a sealant matrix made of collagen, which is coated on the yellow side with human fibrinogen and human thrombin.
Slovenian: Zdravilo TachoSil je kolagenski matriks z lepilom za tkiva, ki je na rumeni strani obložen s humanim fibrinogenom in humanim trombinom.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Slovenian: Uvedeni ukrepi so učinkoviti za viruse z ovojnico, kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa B in virus hepatitisa C ter za virus brez ovojnice, virus hepatitisa A. Ti ukrepi pa imajo lahko le omejeno vrednost proti virusom brez ovojnice, kot je parvovirus B19.
English: Equine collagen Human albumin Riboflavine (E101) Sodium chloride Sodium citrate (E331) L-arginine-hydrochloride.
Slovenian: 6.1 Seznam pomožnih snovi konjski kolagen humani albumin riboflavin (E101) natrijev klorid natrijev citrat (E331) L-argininijev klorid
English: While unrolling the matrix the yellow, active side of the matrix is applied to the bleeding/leaking surface using e.g. a pair of cleansed forceps and held against it with a moist pad under gentle pressure for 3-5 minutes.
Slovenian: Pri odvijanju matriksa rumeno, učinkovito stran matriksa namestite na krvavečo/prepuščajočo površino s pomočjo, npr. dveh očiščenih prijemalk, in nato z vlažno blazinico nežno pritiskajte na površino od 3 do 5 minut.
English: TachoSil may stick to surgical instruments, or gloves or adjacent tissues covered with blood.
Slovenian: Zdravilo TachoSil se lahko prime na kirurške instrumente, rokavice ali sosednja tkiva, na katerih je kri.
English: For smaller wounds, e.g. in minimally invasive surgery, the smaller sizes (4.8 x 4.8 cm or 3.0 x 2.5 cm) or the pre-rolled TachoSil (4.8 cm x 4.8 cm) is recommended.
Slovenian: Za manjše rane, npr. pri minimalno invazivnem kirurškem posegu, priporočamo uporabo matriksov manjše velikosti (4,8 cm x 4,8 cm ali 3,0 cm x 2,5 cm) ali zdravilo TachoSil v že pripravljenem zvitku (4,8 cm x 4,8 cm).
English: For smaller wounds, e.g. in minimally invasive surgery the smaller size matrices (4.8 cm x 4.8 cm or 3.0 cm x 2.5 cm) or the pre-rolled matrix (based on a matrix of 4.8 cm x 4.8 cm) is recommended.
Slovenian: Za manjše rane, npr. pri minimalno invazivnem kirurškem posegu, priporočamo uporabo matriksov manjše velikosti (4,8 cm x 4,8 cm ali 3,0 cm x 2,5 cm) ali matriks v že pripravljenem zvitku (na osnovi matriksa velikosti 4,8 cm x 4,8 cm).
English: The yellow side of TachoSil contains the active components: fibrinogen and thrombin.
Slovenian: Rumena stran zdravila TachoSil vsebuje zdravilni učinkovini fibrinogen in trombin.
English: After removal of the pre-rolled TachoSil from the sterile package it should be applied immediately through the trocar without pre-moistening.
Slovenian: Ko zdravilo TachoSil v obliki že pripravljenega zvitka vzamete iz sterilne ovojnine, ga morate takoj namestiti s pomočjo trokarja, brez predhodnega vlaženja.
English: There is no residual product which needs to be removed; the entire matrix is dissolved (resorbed).
Slovenian: Matriks se v celoti razpusti (resorbira), zato morebitnih ostankov zdravila ni treba odstranjevati.
English: Each sealant matrix is packed in a PET-GAG blister sealed with a coated PE foil.
Slovenian: En matriks z lepilom za tkiva je pakiran v pretisni omot iz PET-GAG-a, ki je zaprt s prevleko iz PE folije.
English: Antibodies against components of fibrin sealant/haemostatic products may occur rarely.
Slovenian: V redkih primerih se lahko razvijejo protitelesa proti sestavinam fibrinskih/hemostatičnih zdravil za zapiranje ran.
English: What TachoSil is and what it is used for What you need to know before TachoSil is used.
Slovenian: Kaj je zdravilo TachoSil in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo TachoSil Kako uporabljati zdravilo TachoSil Možni neželeni učinki
English: The use of TachoSil is restricted to experienced surgeons.
Slovenian: Zdravilo TachoSil lahko uporabljajo le izkušeni kirurgi.
English: Hold down TachoSil with a gentle pressure for 3-5 minutes.
Slovenian: Zdravilo TachoSil nežno pritiskajte od 3 do 5 minut.