natgillin/translations-raw huggingface dataset:
Other medicines and TachoSil Tell your doctor if you are taking, have recently taken or might take any other medicines.
Molimo obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
The marketing authorisation holder shall submit PSUR for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Nositelj odobrenja će prvi PSUR za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EUDR popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenimana europskom internetskom portalu za lijekove.
This also applies to unknown or emerging viruses and other pathogens.
To se odnosi i na nepoznate ili novootkrivene viruse i druge patogene.
These allergic reactions may occur especially if TachoSil is used repeatedly or if you are allergic to any of the ingredients in TachoSil.
Ove se alergijske reakcije mogu naročito pojaviti ako se TachoSil koristi u više navrata ili ako ste alergični na neki od sastojaka TachoSila.
What TachoSil looks like and contents of the pack
Kako TachoSil izgleda i sadržaj pakiranja
TachoSil is made of protein-containing components.
TachoSil se sastoji od sastojaka koji sadrže proteine.
Pre-rolled TachoSil can be used for both open surgery and in minimally invasive surgery, and it can pass through a 10 mm or larger port or trocar.
Prethodno zarolani Tachosil se može koristiti i u otvorenim operacijama i u minimalno invazivnim operacijama, a prolazi kroz otvor ili trokar od 10 mm ili veći.
In the integrated analyses, 997 patients were treated with TachoSil and 984 patients were treated with comparator treatment.
U integriranoj analizi, TachoSilom je liječeno 997 bolesnika, dok je njih 984 podvrgnuto usporednom liječenju.
In case of shock, the current medical standards for shock treatment should be observed.
U slučaju šoka, treba slijediti standardni postupak za liječenje šoka.
Therefore the studies were performed as open-label studies.
Stoga su ispitivanja provedena kao ispitivanja otvorenog tipa.
It is not known whether recent radiation therapy affects the efficacy of TachoSil when used for dura mater sealing.
Nije poznato utječe li nedavna radioterapija na djelotvornost Tachosila kad se primjenjuje za lijepljenje dure mater.
It is possible that you could suffer an allergic reaction after TachoSil has been applied.
Postoji mogućnost da dobijete alergijsku reakciju nakon primjene TachoSila.
What TachoSil is and what it is used for
Što je Tachosil i za što se koristi
Remove the light pressure carefully after 3-5 minutes.
Nakon 3-5 minuta pažljivo popustite pritisak.
The degradation was associated with infiltration of granulocytes and formation of resorptive granulation tissue encapsulating the degraded remnants of TachoSil.
Degradacija je bila povezana s infiltracijom granulocita i stvaranjem resorptivnog granulacijskog tkiva koje obuhvaća degradirane ostatke TachoSila.
Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Proizvođači takvih lijekova također poduzimaju korake u preradi krvi ili plazme koji mogu inaktivirati ili ukloniti viruse.
If more than one matrix is used they should overlap.
Ukoliko se primjenjuje više od jedne matrice, moraju se preklapati.
TachoSil is for local use only and should not be applied inside a blood vessel.
TachoSil je samo za lokalnu primjenu i ne smije ga se primijeniti unutar krvne žile.
The fibrin is then cross linked by endogenous factor XIII, creating a firm, mechanically stable network with good adhesive properties and therefore provides sealing as well.
Tada endogeni faktor XIII umrežuje fibrin, stvarajući čvrstu, mehanički stabilnu mrežicu s dobrim prijanjajućim svojstvima i tako osigurava ljepljenje.
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.
Alternativno, npr. u slučaju jačeg krvarenja, TachoSil se može nanijeti bez prethodnog vlaženja te ga također treba držati pritisnutog na ranu 3-5 minuta.
TachoSil comes ready to use in sterile packages and must be handled accordingly.
TachoSil dolazi spreman za primjenu u sterilnim pakiranjima te se u skladu s tim njime mora odgovarajuće postupati.
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).
Broj ispitanika kod kojih se pojavio događaj ishoda djelotvornosti bio je 25 (6,9%) i 30 (8,2%) za bolesnike u kojih je primijenjen Tachosil odnosno trenutna praksa, s omjerom izgleda 0,82 (95% CI: 0,47; 1.43).
The doctor will place TachoSil on the internal organ to stop the bleeding or to seal the tissue.
Liječnik će postaviti Tachosil na unutarnji organ kako bi zaustavio krvarenje ili zalijepio tkivo.
TachoSil is used under sterile conditions.
TachoSil se koristi pod sterilnim uvjetima.
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.
Prvo kontrolirano kliničko ispitivanje koje je ispitivalo lijepljenje tkiva u kirurgiji pluća, nije pokazalo superiornost u odnosu na standardno liječenje mjereno curenjem zraka zbog učešća velike skupine bolesnika (53%) kod kojih nije bilo curenja zraka.
As with any protein-containing product, allergic type hypersensitivity reactions are possible.
Kao i kod svakog lijeka koji sadrži proteine, moguće su alergijske reakcije preosjetljivosti.
All medicines based on human blood may uncommonly cause allergic reactions.
Svi lijekovi pripravljeni iz ljudske krvi mogu manje često izazvati alergijske reakcije.
In neurosurgery, TachoSil should be applied on top of the primary dura closure.
U neurokirurgiji, Tachosil treba primijeniti preko primarnog šava dure.
In this study, superiority over current practise practice (which included suture, duraplasty and fibrin and polymer sealants or combinations of these) could not be documented.
U tom ispitivanju nije zabilježena superiornost u odnosu na trenutnu praksu (koja je uključivala šavove, duraplastiku ili fibrinska i polimerna ljepila, ili kombinaciju navedenoga).
The active side of TachoSil should be applied so that it extends 1-2 cm beyond the margins of the wound.
Aktivnu stranu Tachosila treba nanijeti tako da za 1-2 cm prelazi rubove rane.
Fibrin sealants/haemostatics are metabolized in the same way as endogenous fibrin by fibrinolysis and phagocytosis.
Fibrinska ljepila/hemostatici se metaboliziraju na isti način kao i endogeni fibrin, fibrinolizom i fagocitozom.
The quantity of TachoSil to be applied should always be oriented towards the underlying clinical need for the patient.
Količinu lijeka TachoSil koji će se primijeniti potrebno je uvijek odrediti prema postojećoj kliničkoj potrebi bolesnika.
The safety data of TachoSil generally reflect the type of post-operative complications related to the surgical settings in which the trials were conducted and the underlying disease of the patients.
Sigurnosni podaci o TachoSilu općenito odražavaju tip postoperativnih komplikacija povezanih s kirurškim okolnostima u kojima su ispitivanja provedena te temeljnom podležećom bolesti ispitanika.
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.
Potpuna degradacija TachoSila je kod nekih životinja opažena 12 mjeseci nakon primjene na jetri, dok su kod drugih i dalje bili prisutni mali zaostaci.
In isolated cases these allergic reactions may progress to anaphylactic shock.
U izoliranim slučajevima takve alergijske reakcije mogu uznapredovati do anafilaktičkog šoka.
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.
U kliničkim ispitivanjima dva su ispitanika ponovno izložena Tachosilu i nisu prijavili imunološki posredovane štetne događaje; međutim, status antitijela na kolagen ili fibrinogen u njih nije poznat.
TachoSil is intended for epilesional use only.
TachoSil je namijenjen samo za epilezijsku primjenu.
TachoSil is indicated in adults for supportive treatment in surgery for improvement of haemostasis, to promote tissue sealing, for suture support in vascular surgery where standard techniques are insufficient, and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery (see section 5.1).
TachoSil je indiciran kod odraslih kao potporno liječenje u kirurgiji za poboljšanje hemostaze, za poticanje ljepljenja tkiva, kao potpora šavovima u vaskularnoj kirurgiji gdje su standardne tehnike nedostatne, te za potporno lijepljenje dure mater kako bi se spriječilo postoperativno istjecanje cerebrospinalne tekućine nakon neuroloških operacija (vidjeti dio 5.1).
If a trocar is used for getting access to the wound, the inside of the trocar should be dry.
Ako se za pristup rani koristi troakar, njegova unutrašnjost mora biti suha.
For minimally invasive surgery, the pre-rolled matrix can be un-rolled with instruments at the site of application.
U minimalno invazivnoj kirurgiji, prethodno zarolana matrica može se odmotati sa instrumentima na mjestu primjene.
What you need to know before TachoSil is used
Što morate znati prije nego počnete primjenjivati Tachosil
TachoSil was found to be well tolerated and safe for use as an adjunct to dura mater closure in neurosurgery.
Tachosil je bio dobro podnošljiv i siguran kao potpora zatvaranju dure mater u neurokirurgiji.
The use of TachoSil is restricted to experienced surgeons.
Primjena TachoSila ograničena je na iskusne kirurge.
Takeda Austria GmbH St. Peter Strasse 25 A-4020 Linz Austria
Takeda Austria GmbH St. Peter Strasse 25 A-4020 Linz Austrija
Tissue sealing in lung surgery was investigated in two controlled trials in patients undergoing lung surgery.
Lijepljenje tkiva u kirurgiji pluća ispitano je u dva kontrolirana ispitivanja kod bolesnika podvrgnutih kirurgiji pluća.
It is important to note that failure to adequately clean adjacent tissues may cause adhesions (see section 4.4).
Važno je napomenuti da neodgovarajuće čišćenje okolnih tkiva može uzrokovati lijepljenje (vidjetio dio 4.4).
The inner sterile blister must be opened in a sterile operating room area.
Unutrašnji sterilni blister mora se otvoriti u sterilnim uvjetima kirurške sale.
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Poduzete mjere mogu biti ograničenog djelovanja protiv virusa bez ovojnice kao što je parvovirus B19.
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.
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjenje u dogovorenom Planu upravljanja rizikom (RMP), a koji je opisan u Modulu 1.8.2
The yellow side of TachoSil is therefore the active side.
Žuta strana Tachosila je stoga djelatna strana.
The yellow side of TachoSil contains the active components: fibrinogen and thrombin.
Žuta strana TachoSila sadrži djelatne tvari: fibrinogen i trombin.
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.
Standardne mjere za prevenciju infekcija nastalih primjenom lijekova dobivenih iz ljudske krvi ili plazme uključuju odabir davatelja, probir individualnih donacija i pulova plazme na specifične markere infekcije te korištenje proizvodnih postupaka učinkovitih u inaktivaciji/uklanjanju virusa.
Fibrinogen is converted into fibrin monomers which spontaneously polymerise to a fibrin clot, which holds the collagen matrix tightly to the wound surface.
Fibrinogen se pretvara u monomere fibrina koji spontano polimeriziraju u fibrinski ugrušak, koji čvrsto drži kolagensku matricu za površinu rane.
What TachoSil contains
Što TachoSil sadrži
This also applies to any unknown or emerging viruses or other types of infections.
To se također odnosi na nepoznate viruse ili novootkrivene viruse ili druge vrste infekcija.
When the active side comes into contact with fluids (such as blood, lymph or saline solution) the fibrinogen and the thrombin are activated and form a fibrin network.
Kada djelatna strana dođe u dodir s tekućinama (poput krvi, limfe ili fiziološke otopine) fibrinogen i trombin se aktiviraju i stvaraju fibrinsku mrežicu.
Instructions Use TachoSil under sterile conditions only.
Upute TachoSil primijenite samo u sterilnim uvjetima.
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).
Kao i kod sličnih lijekova ili trombinskih otopina, ovo se ljepilo može denaturirati u doticaju s otopinama koje sadrže alkohol, jod ili teške metale (npr. antiseptičke otopine).
For viral safety see section 4.4.
Za sigurnost s obzirom na prijenos virusa vidjeti dio 4.4.
TachoSil is used during surgery to stop local bleeding (haemostasis) and to seal tissue surfaces on internal organs.
TachoSil se primjenjuje tijekom kirurške operacije za zaustavljanje lokalnog krvarenja (hemostazu) i ljepljenje površine tkiva unutrašnjih organa.
TachoSil must not be applied intravascularly.
TachoSil se ne smije primijeniti intravaskularno.
The blister is packed in an aluminium-bonded foil sachet with a desiccant bag included and packed in a folding carton.
Blister je pakiran u vrećicu od aluminijske folije zajedno s vrećicom sa sredstvom za sušenje i pakiran u kartonsku kutiju.
This procedure enables an easy adhesion of TachoSil to the wound surface.
Takav postupak omogućuje lako prijanjanje TachoSila na površinu rane.
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).
Parvovirus B19 infekcija može biti ozbiljna za trudnice (infekcija fetusa) i za osobe čiji je imunološki sustav oslabljen ili koje imaju neke vrste anemije (npr. bolest srpastih stanica ili hemolitička anemija).
If more than one matrix is needed, they should overlap.
Ako je potrebno primijeniti više od jedne matrice, njihovi se rubovi moraju preklapati.
The active side of the matrix, which is coated with fibrinogen and thrombin, is marked by a yellow colour.
Aktivna strana matrice, koja je obložena fibrinogenom i trombinom, označena je žutom bojom.
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.
Međutim, drugo ispitivanje u kojem je ispitano lijepljenje plućnog tkiva kod 299 bolesnika (149 TachoSil, 150 standardno kirurško liječenje) kod kojih se javilo intraoperativno curenje zraka, dokazalo je superiornost TachoSila u odnosu na standardno liječenje.
If the dates for submission of a PSUR and the update of an RMP coincide, they can be submitted at the same time.
Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
The equine collagen antibodies that developed in some patients after TachoSil use were not reactive with human collagen.
Antitijela na konjski kolagen koja su se razvila u nekih bolesnika nakon primjene Tachosila nisu bila reaktivna na ljudski kolagen.
Therefore, TachoSil should be administered to pregnant and breastfeeding women only if clearly needed.
Stoga, TachoSil tijekom trudnoće i dojenja treba primjeniti samo kad je to jasno indicirano.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TOTHE SAFE AND EFFECTIVE USE OFTHE MEDICINAL PRODUCT
UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
There were no adverse events attributable to the development of human fibrinogen or equine collagen antibodies.
Nije bilo štetnih događaja koji bi se mogli pripisati razvoju antitijela na ljudski fibrinogen ili konjski kolagen.
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.
Te mjere uključuju pažljivi probir donora krvi i plazme kako bi se isključili oni s povišenim rizikom od prisutnih infekcija te testiranje svake donacije i pulova plazme na znakove prisutnosti virusa/zaraze.
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.
Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom kao što su virus humane imunodeficijencije (HIV), virus hepatitisa B i hepatitisa C te za virus bez ovojnice hepatitisa A.
How does TachoSil work?
Kako TachoSil djeluje?
In animal studies, TachoSil biodegrades after administration to a wound surface with few remnants left after 13 weeks.
U ispitivanjima na životinjama, TachoSil se biodegradira nakon primjene na površinu rane uz malobrojne zaostatke nakon 13 tjedana.
TachoSil can be cut to the correct size and shaped if too large.
Tachosil se može rezati u željenu veličinu i oblik, ako je prevelik.
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.
Kliničko ispitivanje je pokazalo da su neki bolesnici stvorili antitijela na sastojke TachoSila, međutim nisu prijavljene nuspojave koje bi bile posljedica stvaranja tih antitijela.
POLYETHYLENE TEREPHTHALATE BLISTER
BLISTER OD POLIETILEN TEREFTALATA
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.
U dodiru s fiziološkim tekućinama poput krvi, limfe ili fiziološke otopine, sastojci sloja se otope i djelomično difundiraju u površinu rane.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to the patients.
Pri izradi lijekova iz ljudske krvi ili plazme poduzimaju se određene mjere za sprječavanje prijenosa infekcija na bolesnike.
Each matrix contains per cm Human fibrinogen 5.5 mg Human thrombin 2.0 IU
Svaka matrica sadrži po cm ljudski fibrinogen 5,5 mg ljudski trombin 2,0 IU
Use a moistened glove or a moist pad to keep TachoSil in place.
Upotrijebite vlažnu rukavicu ili jastučić za pridržavanje Tachosila na mjestu primjene.
Therefore, intravascular pharmacokinetic studies were not performed in man.
Posljedično tome,ispitivanja intravaskularne famakokinetike nisu provedena kod ljudi.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV and for the non-enveloped virus HAV.
Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom kao što su HIV, HBV i HCV te za virus bez ovojnice HAV.
• Periodic safety update reports(PSURs)
• Periodička izvješća o neškodljivosti lijeka (PSUR-evi)
The efficacy of TachoSil was tested in a randomised controlled study in 726 patients (362 treated with TachoSil and 364 controls) undergoing skull base surgery as an adjunct to suture for sealing the dura mater, in which the efficacy outcome was measured post-operatively as verified cerebrospinal fluid (CSF) leaks or pseudomeningocoele, or treatment failure during surgery.
Djelotvornost Tachosila kao dodatka šavovima za lijepljenje dure mater, ispitana je u randomiziranom kontroliranom ispitivanju na 726 bolesnika (362 u kojih je primijenjen Tachosil i 364 u kontrolnoj skupini) podvrgnutih operaciji baze lubanje, u kojem je ishod djelotvornosti mjeren postoperativno kao potvrđeno istjecanje cerebrospinalne tekućine ili pseudomeningokela, ili kao neuspjeh tijekom operacije.
Wipe the wound surface gently before placing TachoSil on the wound.
Nježno prebrišite površinu rane prije stavljanja Tachosila na ranu.
There is very limited clinical data available regarding re-exposure to TachoSil.
Klinički podaci o ponovnom izlaganju Tachosilu su vrlo ograničeni.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
1 NAME OF THE MEDICINAL PRODUCT
1. NAZIV LIJEKA
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.
Međutim, u kliničkom ispitivanju primjene Tachosila u kirurgiji jetre, u kojem se kod bolesnika pratio razvoj antitijela, 26% od 96 ispitanika u kojih je primijenjen Tachosil razvilo je antitijela na konjski kolagen.
In this study two application techniques for TachoSil were evaluated: application of TachoSil over the dura and application of TachoSil on both sides of the dura.
U ispitivanju su ocjenjivana dva načina primjene TachoSila: primjena Tachosila preko dure i primjena Tachosila s obje strane dure.
After removal of the pre-rolled TachoSil from the sterile package it should be applied immediately through the trocar without pre-moistening.
Nakon vađenja prethodno zarolanog Tachosila iz sterilnog pakiranja, treba ga odmah primijeniti kroz troakar bez prethodnog vlaženja.
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.
Postizanje hemostaze pokazano je kliničkim ispitivanjima provedenim na ukupno 240 bolesnika (119 TachoSil, 121 argonski laser) podvrgnutih djelomičnoj resekciji jetre, i na 185 bolesnika (92 TachoSil, 93 standardno kirurško liječenje) podvrgnutih resekciji površinskog tumora bubrega.
Due to the strong affinity of collagen to blood, TachoSil may also stick to surgical instruments, gloves or adjacent tissues covered with blood.
Zbog jakog afiniteta kolagena prema krvi, TachoSil se može zalijepiti i za kirurške instrumente, rukavice ili okolna tkiva prekrivena krvlju.
4 CLINICAL PARTICULARS
4. KLINIČKI PODACI
TachoSil should be used immediately after opening the inner sterile cover.
TachoSil se mora primjeniti odmah nakon otvaranja unutrašnjeg sterilnog pakiranja.
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.
U kliničkim ispitivanjima je pojedinačna doza najčešće bila u rasponu od 1-3 komada (9,5 cm x 4,8 cm); zabilježene su i primjene do 10 komada po bolesniku.
What is TachoSil used for?
Za što se TachoSil primjenjuje?
TachoSil contains fibrinogen and thrombin as a dried coating on the surface of a collagen matrix.
TachoSil sadrži fibrinogen i trombin u obliku suhog sloja na površini kolagenske matrice.
The doctor treating you will apply TachoSil during surgery.
TachoSil će primijeniti liječnik tijekom kirurške operacije.