natgillin/translations-raw huggingface dataset:
It must not be given as an injection into a blood vessel.
Zdravilo se ne smete dati v obliki injekcije v žilo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Evicel’ s benefits are greater than its risks as supportive treatment in surgery for the improvement of haemostasis where standard techniques are insufficient, and as suture support for haemostasis in vascular surgery.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Evicel pri uporabi kot podporno zdravljenje pri kirurškem posegu z namenom izboljšanja hemostaze, kadar standardne tehnike ne zadostujejo, in z namenom podpore šivom za hemostazo pri vaskularnem kirurškem posegu, večje od z njim povezanih tveganj.
The Committee recommended that Evicel be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Evicel odobri dovoljenje za promet.
Other information about Evicel:
Druge informacije o zdravilu Evicel:
The European Commission granted a marketing authorisation valid throughout the European Union for Evicel to Omrix Biopharmaceuticals S. A. on 6 October 2008.
Evropska komisija je dovoljenje za promet z zdravilom Evicel, veljavno po vsej Evropski uniji, odobrila družbi Omrix Biopharmaceuticals S. A. dne 6. oktobra 2008.
The full EPAR for Evicel can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Evicel je na voljo tukaj.
50-90 mg/ ml 800-1200 IU/ ml
50- 90 mg/ ml 800- 1200 i. e. / ml
Solutions for sealant
raztopine za lepilo za tkivo
Component 1
Raztopina 1
Human clottable protein containing mainly fibrinogen and fibronectin * Component 2
humana koagulacijska beljakovina, ki vsebuje predvsem fibrinogen in fibronektin * Raztopina 2
Human thrombin
humani trombin
800 – 1,200 IU
800 – 1. 200 i. e.
1,600 – 2,400 IU
1. 600 – 2. 400 i. e.
4,000 – 6,000 IU
4. 000 – 6. 000 i. e.
* Total quantity of protein is 80 - 120 mg/ ml
120 mg/ ml
Solutions for sealant.
Raztopini za lepilo.
EVICEL is used as supportive treatment in surgery where standard surgical techniques are insufficient, for improvement of haemostasis (see section 5.1).
Zdravilo EVICEL se uporablja kot podporno zdravljenje za izboljšanje hemostaze pri kirurških posegih, kjer standardne kirurške tehnike ne zadoščajo (glejte poglavje 5. 1).
EVICEL is also indicated as suture support for haemostasis in vascular surgery.
Zdravilo EVICEL je indicirano tudi za podporo šivom pri hemostazi pri žilnih kirurških posegih.
The use of EVICEL is restricted to experienced surgeons.
Zdravilo EVICEL lahko uporabljajo le izkušeni kirurgi.
The volume of EVICEL to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
Volumen zdravila EVICEL, ki se uporabi, ter pogostnost uporabe se vedno določata glede na obstoječe klinične potrebe bolnika.
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.
Uporabljeni odmerek je odvisen od spremenljivk, ki so med drugim vrsta kirurškega posega, velikost področja, način nameravane aplikacije in število nanosov.
In clinical trials in vascular surgery, the individual dosage used was up to 4 ml, whereas in retroperitoneal or intra- abdominal surgery the individual dosage used was up to 10 ml.
V kliničnih preskušanjih v žilni kirurgiji je bil volumen posameznega odmerka do 4 ml, pri retroperitonealnih ali intraabdominalnih kirurških posegih pa je bil volumen posameznega odmerka do 10 ml.
However, for some procedures (e. g. liver traumata) larger volumes may be required.
Vendar bo morda treba pri določenih posegih (npr. poškodbe jeter) uporabiti večje volumne.
Method and route of administration 2 For epilesional use.
2 Za epilezijsko uporabo.
Prepare the solution as described in section 6.6.
Pripravite raztopino, kakor je opisano v poglavju 6. 6.
Before application, the surface of the wound should be as dry as possible.
Pred nanosom naj bo površina rane čimbolj suha.
See section 6.6 for more detailed instructions.
Glejte poglavje 6. 6 za natančnejša navodila.
Life threatening thromboembolic complications may occur if the product is unintentionally applied intravascularly.
Če zdravilo nenamerno uporabite tromboemboličnega zapleta.
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.
Na voljo ni dovolj podatkov, ki bi podpirali uporabo tega zdravila za lepljenje tkiv, nevrokirurške posege, uporabo prek fleksibilnega endoskopa za zdravljenje krvavitve ali pri gastrointestinalnih anastomozah.
Before administration of EVICEL, care is to be taken that parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Pred uporabo zdravila EVICEL morate paziti, da dele telesa izven želenega področja nanosa primerno zaščitite (prekrijete), da preprečite lepljenje tkiva na neželenih mestih.
Signs of hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Znaki preobčutljivostnih reakcij so med drugim koprivnica, generalizirana urtikarija, stiskanje v prsih, sopenje, hipotenzija in anafilaksija.
If these symptoms occur, the administration should be immediately discontinued.
Če se pojavijo ti simptomi, morate uporabo nemudoma prekiniti.
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 zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, so selekcija darovalcev, presejanje posameznih odvzetih enot in združene plazme za specifične označevalce okužbe in vključevanje učinkovitih proizvodnih stopenj za inaktivacijo/ odstranitev virusov.
This also applies to unknown or emerging viruses and other pathogens.
Kljub temu pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni možno povsem izključiti možnosti prenosa povzročiteljev nalezljivih bolezni, tudi tistih, ki do danes še niso poznani, porajajočih se virusov ali drugih povzročiteljev bolezni.
The measures taken are considered effective for enveloped viruses such as HIV, Hepatitis C Virus and Hepatitis B Virus and for the non-enveloped virus Hepatitis A Virus.
Ukrepi, ki se izvajajo, štejejo za učinkovite proti virusom z ovojnico, kot so HIV, virus hepatitisa C in virus hepatitisa B, ter proti virusu hepatitisa A, ki je brez ovojnice.
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoyesis (e. g. haemolytic anaemia).
Okužba s parvovirusom B19 je lahko resna pri nosečnicah (okužba ploda) in posameznikih z oslabljenim imunskim sistemom ali povečano eritropoezo (npr. hemolitična anemija).
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).
Tako kot podobna zdravila ali raztopine trombina lahko zdravilo EVICEL denaturirajo raztopine z alkoholom, jodom ali težkimi kovinami (npr. antiseptiki).
4.6 Pregnancy and lactation
3 4. 6 Nosečnost in dojenje
3 The safety of fibrin sealants/ haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Varnost uporabe fibrinskih lepil/ hemostatikov pri ženskah med nosečnostjo ali dojenjem ni potrjena z nadzorovanimi kliničnimi preskušanji.
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.
Podatki iz študij na živalih ne zadoščajo za oceno varnosti glede reprodukcije, razvoja zarodka ali plodu, poteka gestacije ter peri - in postnatalnega razvoja.
Therefore, the product should be administered to pregnant and lactating women only if clearly needed.
Zato se sme zdravilo EVICEL uporabljati pri nosečnicah in doječih materah samo, kadar je to nedvoumno potrebno.
Adverse reactions which may be reported in association with fibrin sealants are described below.
Spodaj so opisani neželeni učinki, o katerih bi utegnili poročati v povezavi s fibrinskimi lepili.
Since no such reactions have been reported during clinical trials with EVICEL, the frequency of these events with EVICEL is not known.
Ker v kliničnih preskušanjih zdravila EVICEL ti učinki niso bili zabeleženi, pogostnost teh dogodkov pri uporabi zdravila EVICEL ni znana.
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.
V redkih primerih so pri bolnikih, zdravljenih s fibrinskimi lepili/ hemostatiki, možne preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč in zbadajoč občutek na mestu uporabe, bronhospazem, mrazenje, zardevanje, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, slabost, nemir, tahikardijo, stiskanje v prsih, mravljinčenje, bruhanje, sopenje).
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.
Take reakcije lahko nastopijo zlasti pri ponavljajoči uporabi zdravila ali pri bolnikih, za katere je znano, da so preobčutljivi za sestavine zdravila.
Mild reactions can be managed with anti-histamines.
Blage reakcije lahko obvladamo z antihistaminiki.
Severe hypotensive reactions require immediate intervention using current principles of shock therapy.
Resne hipotenzivne reakcije zahtevajo takojšnje ukrepanje po sodobnih smernicah zdravljenja šoka.
Antibodies against components of fibrin sealant/ haemostatic products may occur rarely.
V redkih primerih se lahko razvijejo protitelesa proti sestavinam fibrinskih lepil/ hemostatikov.
Inadvertent intravascular injection could lead to thromboembolic event and DIC, and there is also a risk of anaphylactic reaction (see 4.4).
Nenamerno intravaskularno injiciranje lahko povzroči tromboembolični dogodek in diseminirano intravaskularno koagulacijo, prav tako pa obstaja tveganje za anafilaktično reakcijo (glejte 4. 4).
For safety with respect to transmissible agents, see 4.4.
Varnost pred prenosljivimi povzročitelji je opisana v 4. 4.
The following adverse events which occurred during clinical studies were evaluated as having a possible causal relationship to treatment with EVICEL.
Za naslednje neželene učinke, ki so se pojavili med kliničnimi študijami, je bilo ocenjeno, da bi utegnili biti vzročno povezani z uporabo zdravila EVICEL.
The frequency of all of the events listed below was common (defined as > 1/ 100, < 1/ 10).
Vsi dogodki, našteti spodaj, so bili pogosti (definirano kot > 1/ 100 do < 1/ 10).
Adverse Reactions in Retroperitoneal or Intra-Abdominal Surgery Study Infections and infestations Adverse Reactions in Vascular Surgery Study
Neželeni učinki v študiji uporabe pri retroperitonealnih ali intraabdominalnih kirurških posegih Infekcijske in parazitske bolezni
Infections and infestations Vascular disorders General disorders and administration site conditions
Neželeni učinki v študiji uporabe pri žilnih kirurških posegih Infekcijske in parazitske bolezni Žilne bolezni Splošne težave in spremembe na mestu aplikacije
Graft infection, Staphylococcal infection Haematoma Oedema peripheral
Okužba presadka, stafilokokna okužba Hematom Periferni edem
Investigations Injury, Poisoning and Procedural Complications
Preiskave Poškodbe in zastrupitve in zapleti pri posegih
Decreased haemoglobin Incision site haemorrhage Vascular graft occlusion Wound Post procedural haematoma Post-operative wound complication
Znižan hemoglobin Krvavitev na mestu kirurškega reza Okluzija žilnega presadka Rana
Among 135 patients undergoing retroperitoneal and intra-abdominal surgery (67 patients treated with EVICEL and 68 controls), no adverse events were considered to be causally related to the study treatment according to the investigator assessments.
Pri 135 bolnikih (67 bolnikov zdravljenih z zdravilom EVICEL, 68 bolnikov v kontrolni skupini) po retroperitonealnem ali intraabdominalnem kirurškem posegu po mnenju raziskovalcev noben izmed neželenih učinkov ni bil vzročno povezan s preučevanim zdravilom.
However, 3 serious adverse events (SAE) (one abdominal abscess in the EVICEL group and one abdominal and one pelvic abscess in the control group) were considered by the Sponsor to be possibly related to study treatment.
Vendar pa je sponzor za 3 resne neželene dogodke (abdominalni absces v skupini z zdravilom EVICEL ter abdominalni in medenični absces v kontrolni skupini) menil, da bi lahko bili povezani s preučevanim zdravilom.
Adverse Reactions - Vascular Surgery
Neželeni učinki – žilni kirurški posegi
In a controlled study involving 147 patients undergoing vascular grafting procedures (75 treated with EVICEL and 72 controls), a total of 16 subjects were reported to have had a graft thrombosis/ occlusion adverse event during the study period.
Ti dogodki so bili enakomerno porazdeljeni med obe skupini preiskovancev, t. j.
The events were evenly distributed across treatment arms, with 8 each in the EVICEL and the control groups.
8 primerov v skupini bolnikov, ki so jih zdravili z zdravilom EVICEL, in 8 primerov v kontrolni skupini.
Pharmacotherapeutic group: local haemostatics, ATC code:
Farmakoterapevtska skupina: hemostatiki za lokalno zdravljenje, oznaka ATC:
Factor XIIIa, which is activated form Factor XIII by thrombin, crosslinks fibrin.
Trombin aktivira faktor XIII v faktor XIIIa, ta pa navzkrižno poveže fibrin.
Clinical studies demonstrating haemostasis and suture support were conducted in a total of 147 patients (75 with EVICEL, 72 with control) undergoing vascular surgery with PTFE grafts and in a total of 135 patients (66 with EVICEL, 69 with control) undergoing retroperitoneal and intra- abdominal surgery.
Klinične študije hemostaze in podpore šivom so opravili pri 147 bolnikih (75 jih je prejelo zdravilo EVICEL, 72 jih je bilo vključenih v kontrolno skupino) po žilnih kirurških posegih s presadki iz PTFE in pri 135 bolnikih (66 jih je prejelo zdravilo EVICEL, 69 jih je bilo vključenih v kontrolno skupino) po retroperitonealnih oz. intraabdominalnih kirurških posegih.
No data are currently available for ages younger than 2 years.
5. 2 Farmakokinetične lastnosti
Using 125I-thrombin it was shown that a slow absorption of biologically inactive peptides resulting from the breakdown of thrombin occurred, reaching a Cmax in the plasma after 6-8 hours.
S 125I- trombinom so dokazali, da je absorpcija biološko inaktivnih peptidov, ki nastanejo pri razkroju trombina, počasna, in v plazmi doseže Cmax po 6– 8 urah.
At the Cmax, the plasma concentration represented only 1-2% of the applied dose.
Plazemska koncentracija Cmax je predstavljala le 1– 2% nanesenega odmerka.
Fibrin sealants/ haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Fibrinska lepila/ hemostatiki se presnavljajo na enak način kot endogeni fibrin – s fibrinolizo in fagocitozo.
5 5.3 Preclinical safety data
5 5. 3 Predklinični podatki o varnosti
Studies performed in bacteria to determine mutagenicity were negative for Thrombin alone, Biological Active Component (containing fibrinogen, citrate, glycine, tranexamic acid, and arginine hydrochloride), TnBP alone, and Triton X-100 alone at all concentrations tested.
Študije določanja mutagenosti na bakterijah so bile negativne za sam trombin, biološko aktivno sestavino (vsebuje fibrinogen, citrat, glicin, traneksamsko kislino in argininijev klorid), sam TnBP in sam Triton X - 100 pri uporabljenih koncentracijah.
All concentrations of the combination of TnBP and Triton X-100 also tested negative in assays performed to determine mammalian cell mutageneicity, chromosomal aberrations and micronuclei induction.
Vse koncentracije kombinacije TnBP in Tritona X- 100 so dale negativen rezultat tudi v testih za ugotavljanje mutagenosti za celice sesalcev, kromosomskih aberacij in indukcije mikronukleusa.
No toxicological effects due to the solvent detergent reagents (TnBP and Triton X-100) used in the virus inactivation procedure are expected since the residual levels are less than 5 µg/ ml.
Ni pričakovati toksikoloških učinkov zaradi topnih detergentov (TnBP in Triton X- 100), ki se uporabljata v postopku inaktivacije virusov, ker rezidualne ravni ne presegajo 5 µg/ ml.
No major macroscopic signs of local intolerance and no treatment – related macroscopic findings were observed.
Niso opazili poglavitnih makroskopskih znakov lokalne intolerance ali z zdravljenjem povezanih makroskopskih odkritij.
Arginine hydrochloride Glycine Sodium chloride Sodium citrate Calcium chloride Water for injections
Viala s humanim fibrinogenom: argininijev klorid glicin natrijev klorid natrijev citrat kalcijev klorid voda za injekcije
Calcium chloride Human albumin Mannitol Sodium acetate Water for injections
Viala s humanim trombinom: kalcijev klorid humani albumin manitol natrijev acetat voda za injekcije
Each ml contains 11.6-12.9 mg sodium.
En ml vsebuje 11, 6 do 12, 9 mg natrija.
Store in a freezer at or below -18 C.
Shranjujte v zamrzovalniku pri temperaturi - 18 °C ali nižji.
After thawing, unopened vials can be stored at 2-8 C and protected from light, for up to 30 days, without being frozen again during this period.
Po odtalitvi lahko neodprte viale shranjujete pri 2– 8 C in zaščitene pred svetlobo do 30 dni, vendar jih v tem času ne smete ponovno zamrzniti.
The new expiry date at 2-8 C should be noted on the carton.
Na škatlo morate zapisati nov datum izteka roka uporabnosti pri 2– 8 C.
The Fibrinogen and Thrombin components are stable at room temperature for up to 24 hours but once drawn up into the application device, they must be used immediately.
6 Raztopini s fibrinogenom in trombinom sta stabilni pri sobni temperaturi do 24 ur, po vnosu v aplikator pa ju morate porabiti nemudoma.
6 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
EVICEL is supplied as a package containing two separate vials (glass type I) with rubber stoppers (type I), each containing 1 ml, 2 ml or 5 ml solution of Human Fibrinogen and Human Thrombin, respectively.
Zdravilo EVICEL je na voljo v pakiranju z dvema vialama (steklo tipa I) z gumijastimi zamaški (tipa I), ki vsebujeta 1 ml, 2 ml ali 5 ml raztopine humanega fibrinogena oz. humanega trombina.
6.6 Instructions for use, handling and disposal
6. 6 Navodila za uporabo, ravnanje z zdravilom in odstranjevanje
The instructions for use are also described in the healthcare professionals package leaflet part.
Navodila za uporabo so opisana tudi v razdelku informacije za zdravstveno osebje v navodilu za uporabo.
 Thawing:
 Odtaljevanje:
2-8°C (refrigerator): vials thaw within 1 day, or 20-25°C (room temperature): vials thaw within 1 hour, or 37ºC (e. g. water bath, using aseptic technique, or by warming vials in the hand): vials should be thawed within 10 minutes and must not be left at this temperature for longer than 10 minutes or until fully thawed.
2– 8 °C (hladilnik): viale se odtalijo v 1 dnevu, 20– 25 °C (sobna temperatura): viale se odtalijo v 1 uri, 37 °C (npr. vodna kopel, z aseptično tehniko ali segrevanje v dlani): viale se odtalijo v 10 minutah; pri tej temperaturi jih ne smete pustiti dlje kot 10 minut oziroma dokler se popolnoma ne odtalijo.
The temperature must not exceed 37ºC.
Temperatura ne sme preseči 37 °C.
 Preparation
 Priprava
The solutions are clear or slightly opalescent.
Raztopini sta bistri ali rahlo motni.
EVICEL should be applied using the CE-marked EVICEL application device and optional use of a tip accessory to the device.
Zdravilo EVICEL morate nanesti z aplikatorjem EVICEL, ki ima oznako CE, in z izbirno uporabo nastavka na aplikatorju.
Leaflets giving detailed instructions for use of EVICEL in conjunction with the application device and optional accessory are provided with the package of the application device and of the accessory.
Aplikatorju in nastavkom so priložena navodila za uporabo zdravila EVICEL z aplikatorjem in izbirnimi nastavki.
 Application by dripping
 Nanašanje s kapljanjem
If the applicator tip becomes blocked, the catheter tip can be cut back in 0.5 cm increments.
Če se nastavek aplikatorja zamaši, lahko katetrski nastavek odrežete po 0, 5 cm delčkih.
 Spray application
 Nanašanje s pršenjem
EVICEL can be sprayed using pressurized CO2 or compressed air.
Zdravilo EVICEL lahko pršite s komprimiranim CO2 ali komprimiranim zrakom.
Connect the short tube on the application device to the male luer-lock end of the long gas tube.
Priključite kratko cevko na aplikatorju na moški priključek luer- lock dolge plinske cevke.
Connect the female luer lock of the gas tube (with the 0.2 μ m bacteriostatic filter) to a pressure regulator capable of delivering 1.0 to 2.0 bars pressure.
Priključite ženski priključek luer- lock plinske cevke (z 0, 2- mikrometrskim bakteriostatičnim filtrom) na regulator tlaka, ki lahko zagotovi od 1, 0 do 2, 0 bara.
The pressure regulator should be used in accordance with the manufacturer’ s instructions.
Regulator tlaka morate uporabljati v skladu z navodili izdelovalca.
A pressure of 1.4 to 1.7 bars (measured by gas flow) should be used for spraying.
Za pršenje uporabite tlak od 1, 4 do 1, 7 bara (izmerjeno s pretokom plina).
The distance between the nozzle and the tissue surface should ideally be 10 to 15 cm.
Najbolje je, če je razdalja med šobo in površino tkiva od 10 do 15 cm.
The product should then be sprayed onto the surface of the tissue in short bursts (0.1-0.2 ml) to form a thin, even layer.
Zdravilo nato pršite na površino tkiva v kratkih razprških (0, 1– 0, 2 ml), da nastane tanek, enakomeren sloj.
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 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
 POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
 POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
 OTHER CONDITIONS
 DRUGI POGOJI
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version J/ 11-01-03 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistem farmakovigilance Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici J/ 11 - 01- 03, predstavljeni v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.