natgillin/translations-raw huggingface dataset:
Influenza virus (whole virion, inactivated) containing antigen of strain : A/Vietnam/1203/2004 (H5N1)
Odrasli, starostniki in skupine s posebnimi tveganji Imunski odziv na A/Vietnam/1203/2004 (H5N1)
7.5 micrograms**
A/Vietnam/1203/2004 (H5N1) 7,5 mikrogramov**
Chest discomfort
Imunsko kompromitirani
Headache
BOLEZNI
• feeling sick
• slabo počutje,
• fever
• mrzlica,
PSUR submission when VEPACEL is used during an influenza pandemic:
Predložitev PSUR pri uporabi cepiva VEPACEL med pandemijo gripe: Med pandemičnimi razmerami pogostnost predložitve rednih posodobljenih poročil o varnosti zdravila,
• stomach pain
• bolečine v pazduhah,
• hardness, redness or swelling at the injection site
• otrdlina, rdečina ali oteklina na mestu injiciranja, • utrujenost,
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 September 2013
Datum prve odobritve: 29. september 2013
The frequency of this type of event is not known (cannot be estimated from available data).
Pogosntost tovrstnih dogodkov ni znana (ni je mogoče oceniti na podlagi razpoložljivih podatkov).
At the Cmax, the plasma concentration represented only 1 to 2% of the applied dose.
Pri Cmax plazemska koncentracija predstavlja le 1 do 2 % uporabljenega odmerka.
EVARREST is not recommended for use in children and adolescents under 18 years of age.
Zdravilo EVARREST ni priporočljivo za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
Read this before you open the package
Preberite, preden odprete ovojnino.
In case of shock, standard medical treatment for shock should be implemented.
Če pride do šoka, je treba uporabiti standardno medicinsko zdravljenje za primer šoka.
Such substances should be removed to the greatest possible extent before applying the product.
Takšne snovi je treba pred vstavitvijo matriksa odstraniti v največji možni meri.
The safety and efficacy of EVARREST in children from birth to 18 years has not yet been established.
Varnost in učinkovitost zdravila EVARREST pri otrocih od rojstva do 18. leta starosti še nista bili dokazani.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The following categories are used to rank the adverse reactions by frequency of occurrence: 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); and very rare (<1/10,000), not known (cannot be estimated from the available data).
Neželeni učinki so navedeni po naslednjih kategorijah in pogostnosti: 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); in zelo redki (<1/10.000); neznani (ni mogoče oceniti iz razpoložljivih podatkov).
- for improvement of haemostasis.
- za izboljšanje hemostaze.
You must not be treated with EVARREST if you are allergic to human fibrinogen or human thrombin or to any of the other ingredients of this medicine (listed in section 6).
Z zdravilom EVARREST ne smete biti zdravljeni, če ste alergični na humani fibrinogen ali humani trombin ali katero koli drugo sestavino tega zdravila (navedene v poglavju 6).
In animal studies EVARREST was absorbed by 56 days when used at the anticipated clinical dose.
Pri študijah na živalih se je zdravilo EVARREST resorbiralo v 56 dneh, ko se je uporabljalo v pričakovanem kliničnem odmerku.
It is left in place and is absorbed by the body in approximately 8 weeks.
Zdravilo, ki ostane na mestu, telo absorbira v približno osmih tednih.
None of the patients in any treatment group had a significant change in antibody titre to thrombin or fibrinogen.
V nobeni skupini zdravljenja ni noben od bolnikov imel pomembne spremembe titra protiteles proti trombinu ali fibrinogenu.
The safety of fibrin sealants/haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Varnost fibrinskih lepil/hemostatikov za uporabo med nosečnostjo ali dojenjem ni bila preverjena v nadzorovanih kliničnih preskušanjih.
As a consequence, intravascular pharmacokinetic studies were not performed in man.
Posledično na ljudeh intravaskularne farmakokinetične študije niso bile izvedene.
The product should only be administered according to the instructions recommended for this product (see section 6.6).
Zdravilo je treba vedno uporabljati skladno z navodili, priporočenimi za to zdravilo (glejte poglavje 6.6).
Re-Treatment
Ponovno zdravljenje
All adverse reactions reported during the clinical trials occurred at a frequency of less than 1% (uncommon).
Vsi neželeni učinki, o katerih so poročali v kliničnih preskušanjih, so se pojavljali s pogostnostjo manj kot 1 % (občasni).
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen
For safety with respect to transmissible agents, see section 4.4.
Za varnost v zvezi s prenosljivimi povzročitelji glejte poglavje 4.4.
Read all of this leaflet carefully before this medicine is used to treat you, because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Do not use after the expiry date stated on the carton and label.
Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki.
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.
Z uporabo 125I-trombina je bilo dokazano, da je počasna absorpcija biološko neaktivnih peptidov posledica razgradnje trombina, ki je dosegel najvišje koncentracije v plazmi (Cmax) po 6-8 urah.
There is a also a theoretical possibility that you could develop antibodies to the proteins in EVARREST, which could potentially interfere with blood clotting.
Obstaja tudi teoretična možnost, da razvijete protitelesa na beljakovine v zdravilu EVARREST, ki lahko morebiti vplivajo na strjevanje krvi.
This also applies to any unknown or emerging viruses, or other types of infections.
To velja tudi za neznane ali nove viruse in druge vrste okužb.
Maintain compression for approximately 3 minutes, to control the bleeding.
Pritiskajte približno 3 minute, da obvladate krvavitev.
The European Medicines Agency has deferred the obligation to submit the results of studies with EVARREST in one or more subsets of the paediatric population for the treatment of haemorrhage resulting from a surgical procedure (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom EVARREST za eno ali več podskupin pediatrične populacije za zdravljenje krvavitev, ki so posledica kirurškega postopka (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Of the enrolled subjects, 4.7% of EVARREST treated subjects (18 subjects out of 381) and 2.6% of control subjects (7 subjects out of 272) experienced one or more adverse reactions.
Od vključenih oseb je 4,7 % oseb, zdravljenih z zdravilom EVARREST (18 od 381 oseb), in 2,6 % kontrolnih oseb (7 od 272 oseb) imelo enega ali več neželenih učinkov.
Supportive treatment in adult surgery where standard surgical techniques are insufficient (see section
Podporno zdravljenje pri kirurških posegih pri odraslih, kjer standardne kirurške tehnike ne zadoščajo (glejte poglavje 5.1):
In the integrated analyses, 381 patients were treated with EVARREST and 272 patients were treated with control treatment.
V integriranih analizah je bilo z zdravilom EVARREST zdravljenih 381 bolnikov, 272 bolnikov pa je prejemalo kontrolno zdravljenje.
Natural healing occurs while the fibrin degrades and the product is absorbed by the body; absorption is considered to take approximately 8 weeks, as demonstrated in rodent and swine animal models.
Naravin postopek celjenja se začne, ko se fibrin razgradi in telo absorbira zdravilo; absorpcija naj bi trajala približno 8 tednov, kot je bilo ugotovljeno na primeru glodavcev in svinj.
If these symptoms occur during surgery, the use of the product should be stopped immediately.
Če se ti simptomi pojavijo med operacijo, je treba uporabo zdravila nemudoma prekiniti.
Pharmacotherapeutic group: antihaemorrhagics, local haemostatics, ATC code: B02BC30
Farmakoterapevtska skupina: antihemoragiki, lokalni hemostatiki, oznaka ATC: B02BC30
The fibrin is then cross-linked by endogenous Factor XIII, creating a firm, mechanically stable fibrin network with good adhesive properties.
Fibrin se nato križno poveže z endogenim faktorjem XIII in tako ustvari trdno mehansko stabilno fibrinsko mrežo z dobrimi adhezivnimi lastnostmi.
It is applied directly onto tissue where it sticks firmly and stops bleeding.
Nanese se neposredno na tkivo, kjer se trdno sprime in ustavi krvavitev.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve ter zapleti pri posegih
Due to the nature of surgical procedures and the physiological response to surgical trauma all surgical subjects are at risk for occurrence of thromboembolism.
Zaradi narave kirurških posegov in fiziološkega odziva na kirurško travmo pri vseh operiranih osebah obstaja tveganje za pojav trombembolije.
Study subjects were followed post-operatively through discharge and at Day 30 (+/-14 days) post discharge.
Po kirurškem posegu so osebe v študiji spremljali do odpusta in nato še 30. dan (+/-14 dni) po odpustu.
The safety data for EVARREST reflect the types of post-operative complication generally related to the surgical settings in which the trials were conducted and the underlying disease of the patients.
Varnostni podatki za zdravilo EVARREST se nanašajo na vrste pooperativnih zapletov, ki so bili običajno povezani s kirurškimi okolji, kjer so izvajali preskušanja, in na osnovne bolezni bolnikov.
What you need to know before you are treated with EVARREST:
Kaj morate vedeti, preden boste zdravljeni z zdravilom EVARREST:
The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Uvedeni ukrepi lahko imajo omejeno vrednost proti virusom brez ovojnice, kot je parvovirus B19.
Allergic-type hypersensitivity reactions are possible.
Možne so alergijske preobčutljivostne reakcije.
Transmission of infectious agents
Prenos povzročiteljev okužb
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 primerljiva zdravila ali raztopine trombina se lahko izdelek spremeni, če je izpostavljen raztopinam, ki vsebujejo alkohol, jod ali težke kovine (npr. antiseptične raztopine).
The following adverse events which occurred during clinical studies were considered to be related to the use of EVARREST:
Neželeni učinki, ki so se pojavili med kliničnimi študijami, so bili povezani z uporabo zdravila EVARREST:
As with any protein containing product, allergic-type hypersensitivity reactions are possible.
Tako kot pri vseh zdravilih, ki vsebujejo beljakovine so možne alergijske preobčutljivostne reakcije.
In contact with physiological fluids, e.g., blood, lymph, or physiological saline, the components of the coating are activated, and the reaction of fibrinogen and thrombin initiates the last phase of physiological blood coagulation.
V stiku s fiziološkimi tekočinami, npr. krvjo, limfo ali fiziološko raztopino natrijevega klorida, se aktivirata sestavini obloge in z reakcijo fibrinogena in trombina se prične zadnja faza fiziološke koagulacije krvi.
There is not enough information available to know whether any particular risks are associated with the use of EVARREST during pregnancy or whilst breast-feeding, or whether it could affect fertility.
Ni dovolj razpoložljivih podatkov, da bi vedeli, ali so z uporabo zdravila EVARREST med nosečnostjo ali dojenjem povezana kakršna koli posebna tveganja in ali lahko zdravilo vpliva na plodnost.
Bleeding areas larger than those which can be covered by a single unit of EVARREST have not been investigated in clinical studies.
Uporaba na večjih krvavečih mestih, ki jih ni mogoče prekriti z eno enoto zdravila EVARREST, v kliničnih študijah ni bila preizkušena.
• Risk Management Plan (RMP) The Marketing Authorization 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.
If no other primary haemostatic measures (i.e., standard surgical techniques) appear to be required, repeat the application procedure above with a new EVARREST sealant matrix.
Če niso potrebni nobeni drugi primarni hemostatični ukrepi (npr. standardne kirurške tehnike), zgornji postopek namestitve ponovite z novim matriksom EVARREST.
EVARREST can be used in an actively bleeding field.
Zdravilo EVARREST je mogoče uporabiti na mestu aktivne krvavitve.
In isolated cases, these reactions have progressed to severe anaphylaxis.
V posameznih primerih so te reakcije napredovale v hudo anafilakso.
It is left in place after the operation and is absorbed by the body.
Matriks po operaciji ostane na mestu in ga telo absorbira.
The amount of EVARREST to be applied and the frequency of application should always be oriented towards the underlying clinical needs of the patient.
Pri količini in pogostnosti nanosa zdravila EVARREST se je vedno treba ravnati po osnovnih kliničnih potrebah bolnika.
For instructions on preparation of the medicinal product before administration, see section 6.6.
Za navodila za pripravo zdravila pred nanosom glejte poglavje 6.6.
Do not apply intravascularly
Zdravila ne uporabljajte intravaskularno.
EVARREST does not stick to gloves, forceps, or surgical instruments.
Zdravilo EVARREST se ne prijema na rokavice, klešče ali kirurške instrumente.
Data from eight clinical trials with EVARREST have been pooled into an integrated dataset and the frequencies of occurrence described in the table below originate from this integrated dataset.
Podatke iz osmih kliničnih preskušanj z zdravilom EVARREST so združili v integriran nabor podatkov, iz katerega izhajajo pogostnosti pojavljanja, opisane v spodnji preglednici.
Table 1 Summary of Adverse Reactions to EVARREST MedDRA System Organ Class Preferred Term
Preglednica 1 Povzetek neželenih učinkov za zdravilo EVARREST Organski sistem po MedDRA Priporočeni izraz
What EVARREST is and what it is used for
Kaj je zdravilo EVARREST in za kaj ga uporabljamo
Studies have been conducted in rabbits to evaluate the absorption and elimination of thrombin when applied to the cut surface of the liver resulting from partial hepatectomy.
Študije so bile izvedene na kuncih, kjer so ocenjevali absorpcijo in eliminacijo trombina pri namestitvi na razrezano površino jeter po delni hepatektomiji.
● EVARREST must not be applied intravascularly.
● Zdravila EVARREST se ne sme uporabljati intravaskularno.
A 90-day study in rats to evaluate subchronic systemic toxicity and immunogenicity of EVARREST after subcutaneous implantation found no signs of toxic effects and no evidence of increased immunogenicity relative to fibrin sealant products.
Z 90-dnevno študijo na podganah so ocenjevali subkronično sistemsko toksičnost in imunogenost zdravila EVARREST po subkutani vsaditvi in niso opazili znakov toksičnih učinkov in zvišane imunogenosti, ki je povezana z zdravili, ki vsebujejo fibrinska lepila.
Fibrin sealants/haemostatics are metabolised in the same way as endogenous fibrin, by fibrinolysis and phagocytosis.
Fibrinska lepila/hemostatiki se presnavljajo enako kot endogeni fibrin, s fibrinolizo in fagocitozo.
It is applied by pressing firmly onto bleeding tissue for approximately 3 minutes.
Tesno se pritisne ob krvaveče tkivo za približno tri minute.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped virus hepatitis A virus (HAV).
Uvedeni ukrepi so učinkoviti za viruse z ovojnico, kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV) ter za virus hepatitisa A brez ovojnice (HAV).
The haemostatic efficacy of EVARREST was demonstrated in a number of animal models assessing time to haemostasis and post-treatment blood loss, among other endpoints.
Hemostatska učinkovitost zdravila EVARREST je bila izkazana na številnih živalskih modelih, kjer so med drugimi opazovalnimi dogodki ocenjevali čas do hemostaze in izgubo krvi po zdravljenju.
Fibrinogen is converted into fibrin monomers which spontaneously polymerise to form a fibrin clot that holds the Matrix firmly to the wound surface.
Fibrinogen se pretvori v fibrinske monomere, ki spontano polimerizirajo in tvorijo fibrinski strdek, ki drži matriks trdno na površini rane.
The overall incidence of deep vein thrombosis observed during clinical trials was consistent with published data and does not suggest an increased risk for thrombotic events in EVARREST-treated subjects, although from the available data, this risk cannot be completely ruled out.
Splošna pojavnost globoke venske tromboze, ki so jo opazili med kliničnimi preskušanji, je bila skladna z objavljenimi podatki in ne kaže na zvišano tveganje za trombotične dogodke pri osebah, zdravljenih z zdravilom EVARREST, vendar pa na osnovi razpoložljivih podatkov tveganja ni mogoče povsem izključiti.
This should be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih na dieti s kontroliranim vnosom natrija.
Therefore, the product should be administered to pregnant and lactating women only if clearly needed.
Zato se to zdravilo pri nosečnicah in doječih materah uporablja le, če je to nujno potrebno.
Pleural effusion Pulmonary embolism
Aspiracija Plevralni izliv Pljučna embolija
Telephone: +32 2 746 30 00 Telefax: + 32 2 746 30 01
Telefon: + 32 2 746 30 00 Telefaks: + 32 2 746 30 01
Human fibrinogen (8.1 mg/cm2) Human thrombin (40 IU/ cm2)
- Učinkovini sta: - humani fibrinogen 8,1 mg/cm2 - humani trombin 40 i.e./cm2
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov izdelovalca (izdelovalcev) biološke(ih) zdravilne(ih) učinkovine (učinkovin)
Applications for which adequate data are not available The use of EVARREST has not been studied in the following procedures, and there is therefore no information to show that it would be effective:
Uporaba zdravila EVARREST v naslednjih posegih še ni bila preučevana, zato ni na voljo nobenih informacij, ki kažejo na njegovo učinkovitost:
The Matrix provides physical support and a large surface area for the biological components, imparts inherent mechanical integrity to the product and supports clot formation.
Matriks omogoča fizično podporo in veliko površino za nanos bioloških sestavin in zagotavlja naravno mehansko trdnost izdelku, kar omogoča tvorbo strdkov.
The foil sachet protects EVARREST from moisture and from microbiological contamination.
Vrečka iz folije zdravilo EVARREST ščiti pred vlago in mikrobiološko kontaminacijo.
If you experience any of these symptoms after surgery you should consult your doctor or surgeon.
Če po operaciji opazite katerega koli od teh simptomov, se posvetujte z zdravnikom ali kirurgom.
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.
Na podlagi eksperimentalnih študij na živalih ni mogoče oceniti varnosti zdravila v povezavi s sposobnostjo razmnoževanja, razvojem zarodka ali plodu, potekom nosečnosti ter razvojem pred rojstvom in po njem.
When medicines are made from human blood or plasma, certain measures are put into place to prevent infections being passed on to patients.
Če se zdravilo pripravi iz človeške krvi ali plazme, se uvedejo določeni ukrepi v izogib okužbam, ki bi se lahko prenašale na bolnika.
In clinical trials, the most frequently reported adverse reactions were haemorrhage and increased fibrinogen, and the most serious adverse reactions were aspiration, pulmonary embolism, and haemorrhage.
Pri kliničnih preskušanjih sta bila najpogosteje poročana neželena učinka krvavitev in zvišana raven fibrinogena, najresnejši neželeni učinki pa so bili aspiracija, pljučna embolija in krvavitev.
The tray is in a sachet (polyester laminated aluminum foil) with a seal.
Pladenj je v vrečki (s poliestrom laminirana aluminijasta folija) z zapiralom.
In clinical trials of EVARREST no difference has been observed between EVARREST and control groups with regard to the incidence of thrombotic events, currently suggesting no increased risk with EVARREST use.
V kliničnih preskušanjih z zdravilom EVARREST niso opazili razlike med zdravilom EVARREST in kontrolnimi skupinami glede pojavnosti trombotičnih dogodkov, kar trenutno ne kaže na zvišano tveganje pri uporabi zdravila EVARREST.
Apply the active side of EVARREST to the bleeding area, allowing full contact with the tissue.
Aktivno stran zdravila EVARREST namestite na krvaveče mesto tako, da omogočite popoln stik s tkivom.
EVARREST must not be used in the presence of active infection or in contaminated areas of the body because infection may occur.
Zdravilo EVARREST se ne sme uporabljati v prisotnosti aktivnih okužb ali na kontaminiranih mestih telesa, saj se lahko pojavi okužba.
After the biologic components have been absorbed, the Matrix components (polyglactin 910 and oxidized regenerated cellulose) absorb completely.
Ko se biološke sestavine resorbirajo, se sestavini matriksa (poliglaktin 910 in oksidirana regenerirana celuloza) popolnoma resorbirata.
Thromboembolic complications may occur if the preparation is unintentionally applied intravascularly (see section 4.4).
Če matriks nenamerno uporabimo intravaskularno, lahko pride do tromboemboličnih zapletov (glejte poglavje 4.4).
A post-marketing safety study enrolling 150 subjects was conducted using EVARREST.
V obdobju trženja so z zdravilom EVARREST izvedli študijo varnosti, v katero je bilo vključenih 150 oseb.
Human Thrombin
humani trombin
Applications for which adequate data are not available Adequate data are not available to support the use of this product in neurosurgery or application through a flexible endoscope for treatment of bleeding, in vascular surgery, or in gastrointestinal anastomoses.
Ni zadostnih podatkov za podporo uporabe tega zdravila v nevrokirurgiji ali za nanos skozi prožni endoskop za zdravljenje krvavitve, pri žilnih kirurških posegih ali pri gastrointestinalnih anastomozah.
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.
Pojav takšnih reakcij je še posebej verjeten pri večkratni uporabi zdravila ali pri bolnikih, pri katerih je znana preobčutljivost na sestavine zdravila.
EVARREST was used to treat soft tissue bleeding during retroperitoneal, intra-abdominal, pelvic, or thoracic surgery, suture hole bleeding during cardiovascular surgery, and parenchymal bleeding during hepatic or renal surgery across all clinical trials involving 381 subjects treated with EVARREST and 272 control subjects.
Zdravilo EVARREST so uporabili za zdravljenje krvavitev iz mehkih tkiv pri retroperitonealnih, intraabdominalnih, medeničnih ali torakalnih kirurških posegih, krvavitev iz odprtin ob šivih pri kardiovaskularnih kirurških posegih ter parenhimskih krvavitev pri kirurških posegih na jetrih ali ledvicah v vseh kliničnih preskušanjih, ki so zajemala 381 oseb, zdravljenih z zdravilom EVARREST, in 272 kontrolnih oseb.
EVARREST should only be used in a single layer.
Zdravilo EVARREST se sme uporabiti samo v enem sloju.