natgillin/translations-raw huggingface dataset:
The European Medicines Agency has deferred the obligation to submit the results of studies with VeraSeal in one or more subsets of the paediatric population for the treatment of haemorrhage resulting from a surgical procedure as per paediatric investigational plan (PIP) decision, for the granted indication (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom VeraSeal za eno ali več podskupin pediatrične populacije za zdravljenje krvavitve kot posledice kirurškega posega, pod pogoji, ki so za odobreno indikacijo zdravila navedeni v izvedbenem načrtu za pediatrično populacijo (PIP) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Adequate data are not available to support the use of this product in tissue gluing, neurosurgery, application through a flexible endoscope for treatment of bleeding or in gastrointestinal anastomoses.
Zadostnih podatkov za podporo uporabe tega zdravila pri lepljenju tkiva, nevrokirurgiji, nanosu skozi prožen endoskop za zdravljenje krvavitve ali gastrointestinalnih anastomozah ni na voljo.
These include carefully selecting blood and plasma donors to make sure those at risk of carrying infections are excluded, and testing each donation and pooled plasma for signs of virus/infections.
Ti vključujejo skrbno izbiro darovalcev krvi in plazme, s čimer poskrbimo za izključitev tistih, pri katerih obstaja tveganje, da nosijo okužbo, ter testiranje vsake darovane plazme in zbirk plazme na znake virusov/okužb.
The cold storage chain (- 18 ºC or colder) must not be interrupted until use.
Hladne verige shranjevanja (temperatura -18 °C ali nižja) ne smete prekiniti do uporabe.
• Disposal
• Odstranjevanje
At 37 ºC, the time needed is approximately 5 minutes for the 2 ml, 4 ml, 6 ml, and 10 ml package sizes, but must not be left at this temperature for longer than 10 minutes.
Pri temperaturi 37 ºC je potrebni čas približno 5 minut za velikosti pakiranja 2 ml, 4 ml, 6 ml in 10 ml, ne smemo pa ga pustiti pri tej temperaturi dalj kot 10 minut.
The product should only be administered according to the instructions and with the devices recommended for this product (see section 6.6.
Zdravilo je treba uporabiti skladno z navodili in s pripomočki, priporočenimi za uporabo s tem zdravilom (glejte poglavje 6.6).
- Very common (≥1/10) - common (≥1/100 to <1/10) - uncommon (≥1/1,000 to <1/100) - rare (≥1/10,000 to <1/1,000)
Pogostnosti so opredeljene po naslednjem načelu: - zelo pogosti (≥1/10), - pogosti (≥1/100 do <1/10), - občasni (≥1/1.000 do <1/100), - redki (≥1/10.000 do <1/1.000), - zelo redki (<1/10.000), - neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Manufacturers also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Izdelovalci v obdelavo krvi ali plazme vključijo tudi korake, s katerimi je mogoče inaktivirati ali odstraniti viruse.
Attach the Dual Applicator.
Pritrdite dvojni aplikator.
Spray distance from tissue should be within the range recommended by the marketing authorisation holder of VeraSeal (see section 6.6).
Razdalja pršenja od tkiva mora biti v mejah, ki jih priporoča imetnik dovoljenja za promet z zdravilom VeraSeal (glejte poglavje 6.6).
The instructions for use are also described in the healthcare professionals' package leaflet part.
Navodila za uporabo so opisana tudi v navodilu za uporabo za zdravstvene delavce.
When using the provided Dual Applicator, follow the connection instructions described above.
Pri uporabi priloženega dvojnega aplikatorja se ravnajte po zgoraj opisanih navodilih za pritrditev.
Before administration of VeraSeal, care must be taken that the parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Pred uporabo zdravila VeraSeal je treba poskrbeti za ustrezno zaščito (pokrivanje) delov telesa zunaj načrtovanega območja nanosa, da ne pride do adhezije tkiv na neželenih mestih.
Wipe the end of the applicator using dry or moist sterile surgical gauze.
Obrišite konec aplikatorja s suho ali vlažno sterilno kirurško gazo.
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.
Standardni ukrepi za preprečevanje okužb, ki izvirajo iz uporabe zdravil, izdelanih iz človeške krvi ali plazme, zajemajo izbiro darovalcev, presejanje posameznih donacij in zbirk plazme za specifične označevalce okužb ter vključitev učinkovitih korakov za inaktivacijo/odstranitev virusov v izdelavo zdravila.
The application can be repeated, if necessary.
Nanos je mogoče po potrebi ponoviti.
The amount of VeraSeal that will be applied depends on a number of factors, including the type of surgery, the size of the area to be treated during your operation and the way VeraSeal is applied.
Uporabljena količina zdravila VeraSeal je odvisna od mnogih dejavnikov, vključno z vrsto operacije, velikostjo področja, ki ga je treba zdraviti med posegom, in načinom nanosa zdravila VeraSeal.
If these symptoms occur during surgery, the use of the medicine should be stopped immediately.
Če se ti simptomi pojavijo med kirurškim posegom, je treba uporabo zdravila takoj prekiniti.
In isolated cases, these reactions have progressed to severe anaphylaxis.
V osamljenih primerih so te reakcije napredovale do resne anafilaksije.
To prevent uncontrolled clotting, allow the drops to separate from each other and from the end of the drip tip.
Nekontrolirano strjevanje boste preprečili tako, da boste kapljice ločili eno od druge in od konca kapljalne konice.
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.
Ni dovolj eksperimentalnih študij na živalih za oceno varnosti z vidika razmnoževanja, razvoja zarodka ali ploda, poteka brejosti ter perinatalnega in postnatalnega razvoja.
The surgeon will decide how much is appropriate, and will apply just enough to form a thin, even layer.
Kirurg bo odločil, koliko zdravila je potrebnega, in ga nanesel ravno dovolj, da bo napravilo tanek in enakomeren sloj.
Other CE-marked applicator tips (including open surgery and laparoscopic use devices) intended for specific use with VeraSeal may also be used.
Lahko uporabljate tudi druge aplikatorske konice, označene z oznako CE (vključno s pripomočki za odprte operacije in laparoskopsko uporabo), ki so namenjene za specifično uporabo z zdravilom
Read this leaflet before you open the package.
Preberite ta navodila za uporabo, preden odprete embalažo.
During dripping, keep the end of the drip tip as close to the tissue surface as possible without touching the tissue during application.
Med kapljanjem držite vrh kapljalne konice čim bliže površini tkiva, ne da bi se med nanašanjem zdravila dotaknili tkiva.
If expression is stopped for any reason, change the Airless Spray Tip.
Če se iztiskanje ne glede na razlog ustavi, zamenjajte brezzračno razpršilno konico.
Fertility studies have not been conducted.
Študije plodnosti niso bile izvedene.
MedDRA System Organ Class (SOC)
Organski sistem (SOC) po MedDRA
The most frequent surgery types were simple or radical hysterectomies, abdominoplasties, and radical cystectomies.
Najpogostejše vrste operacij so bile enostavne in radikalne histerektomije, abdominoplastike in radikalne cistektomije.
If this product is accidentally placed inside a blood vessel, it can lead to blood clots, including disseminated intravascular coagulation (DIC) (when blood clots form throughout the blood vessels in the body).
Če bi to zdravilo po nesreči prišlo v notranjost krvne žile, bi lahko povzročilo krvne strdke, vključno z diseminirano intravaskularno koagulacijo (DIK) (kadar krvni strdki nastajajo v krvnih žilah po telesu).
Conversion of fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides.
Pretvorba fibrinogena v fibrin poteka prek razcepa fibrinogena na fibrinske monomere in fibrinopeptide.
Fibrin sealant/haemostatic products are metabolised in the same way as endogenous fibrin by fibrinolysis and phagocytosis.
Fibrinska lepila/hemostatična zdravila se enako kot endogeni fibrin presnavljajo prek fibrinolize in fagocitoze.
VeraSeal must not be used for the treatment of severe or brisk arterial bleeding.
Zdravilo VeraSeal se ne sme uporabljati za zdravljenje močnih ali hitrih arterijskih krvavitev.
After thawing, it is not necessary to warm the product for its use.
Po odtajanju zdravila ni treba segrevati za uporabo.
VeraSeal spray application should only be used if it is possible to accurately judge the spray distance, especially during laparoscopy.
Nanašanje pršila VeraSeal je dovoljeno samo, če je mogoče natančno presoditi razdaljo, v kateri pršite, posebno med laparoskopijo.
Then, connect a new Airless Spray Tip provided in the package and ensure it is firmly connected before use.
Nato nataknite novo brezzračno razpršilno konico iz priloženega pakiranja in se pred uporabo prepričajte, da je čvrsto pritrjena.
- as suture support: in vascular surgery.
- za podporo kirurških šivov: pri žilni kirurgiji.
Other medicines and VeraSeal
Druga zdravila in zdravilo VeraSeal
Position the Airless Spray Tip at least 2 cm away from the target tissue.
Postavite brezzračno razpršilno konico vsaj 2 cm od tarčnega tkiva.
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).
Nehotena intravaskularna injekcija lahko privede do trombemboličnega dogodka in diseminirane intravaskularne koagulacije (DIK), obstaja pa tudi tveganje za anafilaktično reakcijo (glejte poglavje 4.4).
NOTE: Do not trim the Dual Applicator to avoid exposing internal wire.
OPOZORILO: Ne obrežite dvojnega aplikatorja, zato da ne pride do odkritja notranje žice.
- if you are allergic to human fibrinogen or human thrombin or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na humani fibrinogen ali humani trombin ali katero koli sestavino tega zdravila
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT Risk management plan (RMP) 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.
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.
Grasp and bend the Dual Applicator to the desired position.
Primite in upognite dvojni aplikator v želeni položaj.
For instructions on preparation of the medicinal product before administration, see section 6.6.
Za navodila za pripravo zdravila pred dajanjem glejte poglavje 6.6.
As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition of fibrin to fibrin degradation products is initiated.
Ob napredovanju celjenja rane plazmin spodbudi povečano fibrinolitično aktivnost in začne se razgradnja fibrina na njegove razgradne produkte.
The mean age of the study population and its standard deviation was 57.9 (14.5) years.
Povprečna starost populacije v študiji in njena standardna deviacija sta bili 57,9 (14,5) leta.
VeraSeal is intended for epilesional use only.
Zdravilo VeraSeal je namenjeno samo za epilezijsko uporabo.
NOTE: Do not depress plunger during attachment or prior to intended use because the two biologic components will pre-mix in the Airless Spray Tip, forming a fibrin clot that prevents dispensing.
OPOZORILO: Med pritrjevanjem ali pred nameravano uporabo ne pritisnite bata, sicer se bosta obe biološki komponenti prezgodaj zmešali v brezzračni razpršilni konici in bo nastal fibrinski strdek, ki bo preprečil izbrizganje.
VeraSeal is used as a sealant during surgical operations in adults.
Zdravilo VeraSeal se uporablja kot lepilo za tkiva med kirurškimi posegi pri odraslih.
Do not remove the syringe luer cap until thawing is complete and the Dual Applicator is ready to be attached.
Ne odstranite pokrovčka luer za brizgo, dokler ni odtajanje povsem dokončano in ni dvojni aplikator pripravljen za povezovanje.
Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).
Podobno kot pri primerljivih zdravilih ali raztopinah s trombinom, lahko zdravilo postane denaturirano po izpostavljenosti raztopinam, ki vsebujejo alkohol, jod ali težke kovine (npr. antiseptične raztopine).
VeraSeal is supplied as a single-use kit containing two pre-filled syringes (glass type I) with rubber stoppers, each with a sterile frozen solution, assembled in a syringe holder.
Zdravilo VeraSeal je na voljo kot komplet za enkratno uporabo, ki vsebuje dve napolnjeni injekcijski brizgi (steklo tipa I) z gumijastima zamaškoma, vsaka od njiju s sterilno zamrznjeno raztopino, nameščeni v držalu za injekcijski brizgi.
NOTE: Do not reconnect a used drip tip after it has been removed from the adapter; otherwise a clot may form inside the drip tip and the applicator may become unusable.
OPOZORILO: Ne povežite rabljene kapljalne konice še enkrat, potem ko ste jo odstranili z adapterja, sicer utegne nastati strdek v kapljalni konici, aplikator pa lahko postane neuporaben.
The fibrin monomers aggregate and form a fibrin clot.
Fibrinski monomeri agregirajo in tvorijo fibrinski strdek.
Intravascular administration is contraindicated.
Intravaskularno dajanje je kontraindicirano.
Uncommon (may affect up to 1 in 100 people):
Občasni neželeni učinki (lahko se pojavijo pri največ 1 od 100 bolnikov):
If you experience any of these symptoms after surgery, you should immediately consult your doctor or surgeon.
Če se pri vas po kirurškem posegu pojavi kateri koli od teh simptomov, se takoj posvetujte z zdravnikom ali kirurgom.
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Spodnja preglednica sledi razvrstitvi organskih sistemov MedDRA (razvrstitev organskih sistemov in raven priporočenega poimenovanja).
The mean age of the study population and its standard deviation was 63.2 (9.5) years.
Povprečna starost populacije v študiji in njena standardna deviacija sta bili 63,2 (9,5) leta.
The mean age of the study population and its standard deviation was 47.2 (18.4) years.
Povprečna starost populacije v študiji in njena standardna deviacija sta bili 47,2 (18,4) leta.
Prior to applying VeraSeal, the surface area of the wound needs to be dried by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices).
Pred nanosom zdravila VeraSeal je treba površino rane posušiti s standardnimi tehnikami (npr. izmenično uporabo kompres, gaz, pripomočkov za sesanje).
1 Dual Applicator with 2 additional Airless Spray Tips.
1 dvojni aplikator z 2 dodatnima brezzračnima razpršilnima konicama.
After thawing, remove the blister from the surface at room temperature or from the refrigerator at 2 °C - 8 °C.
Po odtajanju odstranite pretisni omot s površine na sobni temperaturi ali iz hladilnika pri temperaturi 2 °C - 8 °C.
Do not use solutions that are cloudy or have deposits.
Ne uporabite raztopin, ki so motne ali v katerih so oborine.
The product may be affected after contacting solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions).
Na zdravilo lahko vpliva stik z raztopinami, ki vsebujejo alkohol, jod ali težke kovine (npr. antiseptične raztopine).
Within each frequency grouping, adverse reactions are presented in order of decreasing of seriousness.
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of this medicinal product.
Uporaba zdravila VeraSeal je omejena na izkušene kirurge, ki so bili usposobljeni za uporabo tega zdravila.
• Room temperature thawing (preferred method)
• Odtajanje pri sobni temperaturi (prednostna metoda)
- Nausea - Pain caused by the surgery - Pruritus (itching)
- bolečina, ki jo povzroči operacija, - pruritus (srbenje).
VeraSeal contains the component of fibrin sealant.
Zdravilo VeraSeal vsebuje komponente fibrinskega lepila.
Instituto Grifols, S.A. Polígono Levante c/Can Guasc 2
Polígono Levante c/Can Guasc 2 Barcelona
Place the blister containing the syringe holder with pre-filled syringes on a surface at room temperature (20 ºC - 25 ºC) for approximately 70 minutes for the 2 ml and the 4 ml package sizes for approximately 90 minutes for the 6 ml and the 10 ml package sizes
Položite pretisni omot z držalom za brizgi z napolnjenima brizgama na površino na sobni temperaturi (20 ºC - 25 ºC) za približno 70 minut za velikosti pakiranja 2 ml in 4 ml; za približno 90 minut za velikosti pakiranja 6 ml in 10 ml.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
VeraSeal must not be applied intravascularly.
Zdravilo VeraSeal se ne sme uporabljati intravaskularno.
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Okužba s parvovirusom B19 je lahko resna pri nosečih ženskah (okužba ploda) ter posameznikih z imunsko pomanjkljivostjo ali povečano eritropoezo (npr. hemolitična anemija).
If you experience an allergic reaction you might have one or more of the following symptoms: swelling under skin (angioedema), skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, heart rate increase, tingling, vomiting or wheezing.
Če se pri vas pojavi alergijska reakcija, lahko imate enega ali več od naslednjih simptomov: oteklina pod kožo (angioedem), kožni izpuščaj, koprivnica (urtikarija), stiskanje v prsih, mrzlica, vročinski oblivi, glavobol, nizek krvni tlak, letargija, siljenje na bruhanje, nemir, pospešen krvni utrip, mravljinčenje, bruhanje ali sopenje.
During the vascular surgery study 225 subjects were enrolled and underwent vascular surgical procedures utilizing polytetrafluoroethylene graft material on end-to-side arterial anastomosis or on upper extremity vascular access arterial anastomosis.
V študijo vaskularnih operacij so vključili 225 bolnikov, ki so prestali žilne kirurške posege, pri katerih so uporabljali presadke iz politetrafluoroetilena v arterijski anastomozi end-to-side ali v arterijski anastomozi za vaskularni dostop do zgornjega uda.
When using other applicator tips, follow the instructions for use that are provided with the applicator tips.
Pri uporabi drugih aplikatorskih konic se ravnajte po navodilih za uporabo, ki so priložena aplikatorskim konicam.
What VeraSeal looks like and contents of the pack
Izgled zdravila VeraSeal in vsebina pakiranja
Place the blister containing the Dual Applicator at room temperature until the fibrin sealant is ready to use.
Pustite pretisni omot z dvojnim aplikatorjem na sobni temperaturi, dokler ne bo fibrinsko zdravilo za lepljenje tkiv pripravljeno za uporabo.
One Dual Applicator with two additional Airless Spray Tips is supplied with the product, for application by spraying or dripping.
En dvojni aplikator z dvema dodatnima brezzračnima razpršilnima konicama je priložen zdravilu za uporabo s pršenjem ali kapljanjem.
Official batch release
• Uradna sprostitev serije
Application of the product must be individualised by the treating physician.
Nanos zdravila mora individualno prilagoditi lečeči zdravnik.
VeraSeal solutions for sealant human fibrinogen/human thrombin
VeraSeal raztopine za lepilo za tkiva humani fibrinogen/humani trombin
For medicines such as VeraSeal that are made from human blood or plasma, certain measures are taken to prevent infections being passed on to patients.
Posebno varnostno opozorilo Pri zdravilih, kot je zdravilo VeraSeal, ki so izdelana iz humane krvi ali plazme, se uporabljajo določeni ukrepi za preprečevanje prenosa okužb na bolnike.
The dose to be applied is governed by variables including, but not limited to, the type of surgical intervention, the size of the area and the mode of intended application, and the number of applications.
Odmerek za nanos je odvisen od več spremenljivk, vendar z njimi ni omejen, med drugim z vrstami kirurškega posega, velikostjo področja, načinom načrtovanega nanosa in številom nanosov.
Thaw VeraSeal pre-filled syringes inside the sterile field in a sterile thermostatic water bath at a temperature not higher than 37 ºC using the following steps:
Odtajajte napolnjeni brizgi zdravila VeraSeal v sterilnem polju v sterilni termostatirani vodni kopeli pri temperaturi, ki ni višja od 37 ºC, z naslednjimi koraki:
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Kljub tem ukrepom pri uporabi zdravil, izdelanih iz človeške krvi ali plazme, ni mogoče povsem izključiti možnosti prenosa okužbe.
- Abdominal abscess (swollen area in abdomen caused by infection) - Abdominal wound dehiscence (wound breakdown due to incomplete healing) - Leak of bile (a liquid produced by the liver) after the procedure - Cellulitis (infection of the skin) - Deep vein thrombosis (blood clots in the blood vessels) - Liver abscess (swollen area in the liver caused by infection) - Peritonitis (inflammation of the wall of the abdomen) - Positive parvovirus B19 test (laboratory result showing infection with the virus) - Postoperative wound infection - Pulmonary embolism (blood clots in blood vessels in the lungs) - Wound infection
- trebušni absces (otekel predel v trebuhu, ki ga povzroči okužba), - dehiscenca trebušne rane (razprtje rane zaradi nepopolnega celjenja), - iztekanje žolča (tekočine, ki jo izdelujejo jetra) po posegu, - celulitis (okužba kože), - tromboza globokih ven (krvni strdki v krvnih žilah), - absces jeter (otekel predel jeter, ki ga povzroči okužba) - peritonitis (vnetje trebušne mrene), - pozitivna preiskava na parvovirus B19 (laboratorijski rezultat, ki kaže na okužbo s tem virusom), - postoperativna okužba rane, - pljučna embolija (krvni strdki v krvnih žilah v pljučih), - okužba rane.
Place the syringe holder with pre-filled syringes directly into the sterile water bath ensuring that it is completely immersed in the water.
Položite držalo za brizgi z napolnjenima brizgama neposredno v sterilno vodno kopel in se prepričajte, da je popolnoma potopljeno v vodo.
Solutions that are cloudy or have deposits should not be used.
Raztopin, ki so motne ali vsebujejo delce, ne smete uporabiti.
Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia).
Okužba s parvovirusom B19 je lahko resna pri nosečih ženskah (okužba ploda) ter posameznikih z zavrtim imunskim sistemom ali tistih z določenimi vrstami anemije (npr. srpastocelično anemijo ali hemolitično anemijo).
See Figure 8.
Glejte sliko 8.
The most frequent surgery types were femoral-popliteal bypass grafting, upper extremity vascular access for hemodialysis, and ilio-femoral bypass grafting.
Najpogostejše vrste operacij so bile femoralno poplitealna premostitvena operacija, vaskularni dostop do zgornjega uda za hemodializo in iliofemoralna premostitvena operacija.
Frozen solutions.
Zamrznjene raztopine.