natgillin/translations-raw huggingface dataset:
1 pre-filled syringe (0.5 ml) 
1 napolnjena injekcijska brizga (0,5 ml)
Heterologous booster vaccinations 
Heterologna poživitvena cepljenja
MINIMUM PARTICULARS ATTACHED TO THE OUTER CARTON OF MULTIDOSE CONTAINER AND PRE-FILLED SYRINGE 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI IN SO PRIPETI NA ZUNANJO ŠKATLO VEČODMERNEGA VSEBNIKA IN NAPOLNJENE INJEKCIJSKE BRIZGE
After first opening, the vaccine should be used immediately (within a maximum period of 3 hours). 
Po prvem odprtju cepivo uporabite nemudoma (v največ 3 urah)
In addition, during a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue. 
Poleg tega med trajanjem pandemije, viri, potrebni za poglobljeno vrednotenje rednih posodobljenih poročil o varnosti zdravila v obliki, kot je definirana v Pravilih, ki urejajo zdravila v Evropski skupnosti (”Rules Governing Medicinal Product in the
a) The following side effects have been reported in a clinical study in infants aged 6 to 35 months. 
a) V klinični študiji so poročali o naslednjih neželenih učinkih pri dojenčkih, starih od 6 do 35 mesecev.
1 pack of a pre-filled syringe containing a single dose of 0.5 ml suspension for injection with a latex-free plunger (halogeno-butyl-rubber) without needles. 
1 zavitek napolnjeni brizgi, ki vsebuje en odmerek 0,5 ml suspenzije za injiciranje z batom brez lateksa (halogeno-butil-guma) brez igle.
Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years: 
Dojenčki, otroci in mladostniki, stari od 6 mesecev do 17 let in odrasle osebe, stare 18 let in več: Daje se en odmerek po 0,5 ml.
Prepandemic influenza vaccine (H5N1) 
Predpandemsko cepivo proti gripi (H5N1) i.m.
There are no data on co-administration of VEPACEL with other vaccines. 
Ni podatkov o sočasnem cepljenju s cepivom VEPACEL in drugimi cepivi.
Sensory disturbance (paresthesia, dysesthesia, oral dysesthesia, hypoesthesia, dysgeusia, and burning sensation) 
hipestezija, oralna disestezija, disgevzija in pekoč občutek)
21 Days after 1st Dose 2nd Dose 1st Dose 2nd Dose 1st Dose 2nd Dose 
1. odmerku 2. odmerku 1. odmerku 2. odmerku
PEEL OFF´S (1 PEEL OFF PER DOSIS) 
ODSTRANLJIVE NALEPKE (1 ODSTRANLJIVA NALEPKA NA ODMEREK)
Trometamol Sodium chloride Water for injections Polysorbate 80 
trometamol natrijev klorid voda za injekcije polisorbat 80
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/. 
Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Podrobne informacije o cepivu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
After first opening, the vaccine should be used immediately. 
Cepivo uporabite nemudoma po prvem odprtju.
Each vaccine dose of 0.5 ml is withdrawn into a syringe for injection. 
Vsak odmerek cepiva 0,5 ml posesajte v brizgo za injiciranje.
How VEPACEL is given 
Kako se cepivo VEPACEL daje
4.7 Effects on ability to drive and use machines 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji VEPACEL ima blag vpliv na sposobnost vožnje in upravljanja s stroji.
• flu-like illness 
• gripi podobna bolezen,
INFECTIONS AND INFESTATIONS 
INFEKCIJSKE IN PARAZITSKE BOLEZNI
One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber). 
Eno pakiranje po 20 večodmernih vsebnikov (iz stekla vrste I) s 5 ml suspenzije (10 odmerkov po 0,5 ml) z zamaškom (iz bromobutilne gume).
• insomnia (difficulty sleeping) 
• otečene žleze, • nespečnost (težave pri spanju),
VEPACEL is presented as a suspension for injection in a pre-filled syringe. 
VEPACEL je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi.
You should not receive VEPACEL 
Cepiva VEPACEL ne smete prejeti
Urticaria 
VEPACEL
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10 DOSE VIAL 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - VIALA Z 10 ODMERKI
Very rare (affects less than 1 user in 10,000): 
Zelo redki (pojavijo se pri manj kot 1 od 10.000 oseb):
MARKETING AUTHORISATION NUMBER EU/1/12/752/002 
EU/1/12/752/002
12 - 24 months booster 
Poživitveno cepljenje po 12 do 24 mesecih
The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in a clinical trial in children and adolescents aged 9 to 17 years (N=288), in children aged 3 to 8 years (N=146) and in infants and children aged 6 to 35 months (N=33) following a 0, 21 day schedule. 
Imunogenost cepilnega seva A/Vietnam/1203/2004 je bila ocenjena v kliničnem preskušanju pri otrocih in mladostnikih, starih od 9 do 17 let (N=288), pri otrocih, starih od 3 do 8 let (N=146) ter dojenčkih in otrocih, starih od 6 do 35 mesecev (N=33), po shemi cepljenja 0. in 21. dan.
SKIN AND 
KOŽE IN PODKOŽJA
Ireland 
Avstrija
• irritability 
• razdražljivost.
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS 
BOLEZNI MIŠIČNO-SKELETNEGA SISTEMA IN VEZIVNEGA TKIVA
neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome 
• nevrološke motnje, kot so encefalomielitis (vnetje osrednjega živčnega sistema), nevritis (vnetje živcev) in vrsta paralize, ki ji pravimo Guillain-Barréjev sindrom.
VEPACEL may affect your ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Cepivo VEPACEL lahko vpliva na sposobnost vožnje in upravljanja s stroji.
The observed adverse reactions from a paediatric clinical trial with the H5N1 vaccine are listed below. 
V nadaljevanju so navedeni neželeni učinki, opaženi v pediatričnem kliničnem preskušanju cepiva proti H5N1.
MARKETING AUTHORISATION NUMBER EU/1/12/752/001 
EU/1/12/752/001
Cross-reactive immune response against related H5N1 strains In a clinical study in adults aged 18 to 59 years (N=265) and in older people aged 60 years and above (N=270) after vaccination with the A/Vietnam/1203/2004 strain vaccine, the rate of subjects with cross-neutralising antibodies as measured by MN (titre ≥ 20) was as follows: 
V klinični študiji pri odraslih, starih od 18 do 59 let (N=265), in starejših osebah, starih 60 let in več (N=270) je bil po cepljenju s cepivom iz seva A/Vietnam/1203/2004 odstotek oseb z navzkrižnimi nevtralizacijskimi protitelesi, izmerjen z mikronevtralizacijo (titer ≥ 20), naslednji:
VEPACEL is presented as a suspension for injection in multidose vial (10 doses of 0.5 ml per vial) in pack size of 20 vials. 
Kaj VEPACEL izgleda in vsebina pakiranja VEPACEL je na voljo kot suspenzija za injiciranje v večodmernem viali (10 odmerkov po 0,5 ml) v pakiranjih po 20 vial.
Immune response against A/Vietnam/1203/2004 (H5N1) The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in two clinical studies in subjects aged 60 years and older (N=391) following a 0, 21 day schedule. 
Imunogenost cepilnega seva A/Vietnam/1203/2004 je bila ocenjena v treh kliničnih študijah pri odraslih, starih od 18 do 59 let (N=961) in v dveh kliničnih študijah pri starostnikih, starih 60 let in več (N=391), in sicer po shemi cepljenja 0. in 21. dan.
Very Common (≥1/10) Common (≥1/100 - <1/10) Uncommon (≥1/1,000 - <1/100) Rare (≥1/10,000 - <1/1,000) 
Pogosti (≥1/100 do <1/10)
• feeling cold c) The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years. 
c) V kliničnih študijah so poročali o naslednjih neželenih učinkih pri mladostnikih, starih od 9 do 17 let.
One pack of 1 single dose pre-filled syringe (type I glass) containing 0.5 ml suspension for injection, with a latex-free plunger stopper (halogeno-butyl rubber) without needles. 
Eno pakiranje z 1 enoodmerno napolnjeno injekcijsko brizgo (iz stekla vrste I) z 0,5 ml suspenzije za injiciranje in zamaškom bata brez kavčuka (iz halogenobutilne gume) brez igel.
No case of overdose has been reported for VEPACEL. 
Ni poročil o primerih prevelikega odmerjanja cepiva VEPACEL.
The immunological response may be diminished if the patient is undergoing treatment with immunosuppressants. 
Če se bolnik zdravi z imunosupresivnimi zdravili, je odziv imunskega sistema lahko manjši.
- If you get any of the side effects, talk to your doctor or nurse. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali z medicinsko sestro.
After vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and seroconversion factor as measured by MN assay in immunocompromised subjects and patients with chronic disease conditions were as follows: 
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju preiskovancev, ki so bili imunsko kompromitirani ali pri bolnikov s kroničnimi bolezenskimi stanji, so bili naslednji:
• dry throat 
• suho grlo, • bruhanje,
If you get any side effects talk to your doctor or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali z medicinsko sestro.
• rash, hives 
• kašelj, • driska,
Clear to opalescent suspension. 
Bistra do prekinitve motni.
After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months to 17 years were as follows: 
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju dojenčkov, otrok in mladostnikov, starih od 6 mesecev do 17 let, so bili naslednji: Test mikronevtralizacije
Multidose vial (10 doses of 0.5 ml per vial) 
Večodmerna viala (v viali je 10 odmerkov po 0,5 ml)
Very common (affects more than 1 user in 10): 
Zelo pogosti (pojavijo se pri več kot 1 od 10 oseb):
Common (affects 1 to 10 users in 100): 
Pogosti (pojavijo se pri 1 do 10 od 100 oseb):
• fits due to fever 
• epileptični napadi zaradi zvišane telesne temperature,
History of anaphylactic reactions to the active substance, or to any of the excipients listed in section 6.1, or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein). 
navedeno v poglavju 6.1, ali ostanke v sledeh (npr. formaldehid, benzonaza, saharoza, tripsin,
Clinical trials were conducted with the H5N1 vaccine (see section 5.1 for more information on the H5N1 vaccines) in approximately 3700 subjects (ranging in age groups from 18 to 59 years and 60 years and above) and special risk groups of approximately 300 subjects each, consisting of immunocompromised subjects and patients with chronic disease conditions. 
Klinična preskušanja s cepivom proti H5N1 (glejte poglavje 5.1 za več informacij o cepivih proti H5N1) so bila opravljena pri približno 3700 preiskovancih (starih od 18 do 59 let in od 60 let naprej)
What VEPACEL is and what it is used for What you need to know before you receive VEPACEL How VEPACEL is given 
Kaj morate vedeti, preden boste prejeli cepivo VEPACEL Kako se cepivo VEPACEL daje
These side effects may occur with VEPACEL. 
Ti neželeni učinki se lahko pojavijo po cepljenju s cepivom VEPACEL.
Rare (affects 1 to 10 users in 10,000): 
Redki (pojavijo se pri 1 do 10 od 10.000 oseb):
• hardness, redness, swelling or bruising at the injection site 
• otrdlina, rdečina, oteklina ali podplutba na mestu injiciranja,
STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml) contains: 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 odmerek (0,5 ml) vsebuje:
There are no post-marketing data available for VEPACEL. 
Za cepivo VEPACEL ni na voljo podatkov o spremljanju po pridobitvi dovoljenja za promet.
• neurological disorders such as encephalomyelitis (inflammation of the central nervous system), 
Nevrološke motnje, kot so encefalomielitis,
• allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, 
• alergijske reakcije, ki povzročijo nevarno znižanje krvnega tlaka, ki lahko vodi do šoka, če ne ukrepamo; zdravniki poznajo to možnost in imajo pripravljeno nujno zdravljenje za takšne primere,
What VEPACEL contains 
Kaj vsebuje cepivo VEPACEL
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS 
SPLOŠNE TEŽAVE IN SPREMEMBE NA MESTU APLIKACIJE
Influenza virus (whole virion, inactivated), containing antigen of*strain: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** * produced in Vero cells ** haemagglutinin 
A/Vietnam/1203/2004 (H5N1) 7,5 mikrogramov** * pripravljen v celicah Vero
Uncommon (affects 1 to 10 users in 1,000): 
Občasni (pojavijo se pri 1 do 10 od 1.000 oseb):
A/Vietnam A/Indonesia A/Vietnam A/Indonesia A/Vietnam A/Indonesia 12 Month Booster 94.1% 93.1% 94.7% 97.2% 100.0% 100.0% 
A/Vietnam A/Indonesia A/Vietnam A/Indonesia A/Vietnam A/Indonesia poživitveni odmerek po 12 mesecih
Vomiting Diarrhoea 
ŽILNE BOLEZNI
NAME OF THE MEDICINAL PRODUCT VEPACEL suspension for injection in pre-filled syringe Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture) 
Cepivo proti prepandemski gripi (H5N1) (s celimi virioni, inaktivirano, pripravljeno v celični kulturi)
2nd Dose 
PRILOGA II
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to 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.
A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered 12 months after a priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25). 
Poživitveno cepljenje s 7,5 µg heterolognega cepilnega seva A/Indonesia/05/2005 brez adjuvansa je bilo uporabljeno pri otrocih in mladostnikih, starih od 9 do 17 let (N=196), pri otrocih, starih od 3 do
• pain in the armpit 
• bolečine v okončinah,
• stuffy nose 
• izcedek iz nosu,
Uncommon (affects 1 to 10 users in 1,000): • generalised skin reactions including urticaria (hives) 
Občasni (pojavijo se pri 1 do 10 od 1.000 oseb): • zmanjšan apetit,
METHOD OF ADMINISTRATION Shake before use 
POSTOPEK UPORABE Pred uporabo pretresite.
Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows: 
Odstotki seronevtralizacije (titer MN ≥ 20) 21 dni po poživitvenem cepljenju po 12 mesecih s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, testirani proti homolognemu in heterolognemu sevu,
Ology Bioservices Ireland LTD Wilton Park House Wilton Place 
Wilton Park House
Rare: neuralgia, transient thrombocytopenia. 
Občasni: generalizirane kožne reakcije Redki: nevralgija, prehodna trombocitopenija.
Malaise 
ŽIVČEVJA
What is in this leaflet: 
so bili naslednji:
• bruising at the injection site 
• zatrdlina na mestu injiciranja
There are no post-marketing surveillance data available for VEPACEL. 
• Spremljanje po pridobitvi dovoljenja za promet Za cepivo VEPACEL ni na voljo podatkov o spremljanju po pridobitvi dovoljenja za promet.
Sixteen ferrets were divided into two cohorts and were vaccinated on days 0 and 21 with 7.5 µg of the A/Vietnam/1203/2004 vaccine or were sham vaccinated. 
Šestnajst dihurjev je bilo razdeljenih v dve skupini, cepljeni pa so bili na 0. in 21. dan z odmerkom
In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were administered the H5N1 vaccine. 
Otroci in mladostniki, stari od 3 do 17 let: V kliničnem preskušanju je cepivo proti H5N1 prejelo 300 mladostnikov, starih od 9 do 17 let,
However, if this cannot be avoided, the immunoglobulins should not be injected into the same arm used for VEPACEL. 
imunoglobulinov ne smete vbrizgati v roko, v katero je bilo dano cepivo VEPACEL.
Arthralgia Myalgia 
** hemaglutinina
A booster with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine administered 12 months after a single dose priming vaccination with the A/Vietnam/1203/2004 strain vaccine was also evaluated in adults aged 18 to 59 years. 
Odraslim, starim od 18 do 59 let so 12 mesecev po primarnem cepljenju z enim odmerkom cepiva s sevom A/Vietnam/1203/2004 dali heterologno poživitveno cepivo s 7,5 µg formulacijo cepiva s sevom A/Indonesia/05/2005 brez adjuvansa.
The vaccine contains 10 doses of 0.5 ml. 
Cepivo vsebuje 10 odmerkov po 0,5 ml. Vsak odmerek po 0,5 ml potegnite v brizgo za injiciranje.
Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period. 
Po uporabi podobnega cepiva proti gripi H1N1 s celimi virioni, razmnoženimi v celicah Vero, v pandemiji so ugotovili preobčutljivostne reakcije, vključno z anafilakso.
Manufacturer 
APLIKACIJE
The vaccine should not be administered intravascularly. 
Cepiva ne smete injicirati v žilo.
** ≥ 4-fold increase in MN titer *** geometric mean increase 
Faktor serokonverzije*** 1,6 * titer MN ≥ 20 ** ≥ 4-kratno povečanje titra MN *** geometrična sredina povečanja
There is no information on the use of VEPACEL under the skin. 
Ni podatkov o subkutanem injiciranju cepiva VEPACEL.
Allergic reactions, including sudden life-threatening allergic reactions (anaphylaxis) have been reported following use of a similar vaccine for H1N1 influenza during a pandemic period. 
so opisane pri podobnih cepivih proti H1N1 (cepivih proti prašičji gripi), uporabljenih med pandemijo.
• chest discomfort 
• splošno slabo počutje,
Sodium chloride Water for injections Polysorbate 80. 
- Druge sestavine cepiva so trometamol, natrijev klorid, voda za injekcije, polisorbat 80.
NAME OF THE MEDICINAL PRODUCT VEPACEL 
IME ZDRAVILA
NERVOUS SYSTEM DISORDERS 
Razvrstitev po organskih sistemih
Children and adolescents aged 3 to 17 years: 
in 153 otrok, starih od 3 do 8 let.
Influenza-like illness 
OČESNE BOLEZNI
After primary vaccination the rate of subjects with neutralising antibody titres > 20, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older people aged 60 years and above were as follows: 
Imunogenost pri odraslih, starih od 18 do 59 let (N=961), in osebah, starih 60 let in več (N=391) Odstotek oseb, ki imajo titer nevtralizirajočih protiteles večji od 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po prvem cepljenju odraslih,
MN assay 
Wilton Place
• hardness, redness, swelling or bruising at the injection site b) The following side effects have been reported in clinical studies in children aged 3 to 8 years. 
b) V kliničnih študijah so poročali o naslednjih neželenih učinkih pri otrocih, starih od 3 do 8 let.
Influenza virus (whole virion, inactivated), containing antigen* of strain: A/Vietnam/1203/2004 (H5N1) 
Virus gripe (celotni virioni, inaktiviran), ki vsebuje antigen* seva:
Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows: 
21 dni po poživitvenem cepljenju s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, pri čemer je bil uporabljen tako homologen kot tudi heterologen sev cepiva, so bili odstotki seronevtralizacije (titer MN ≥ 20) , naslednji:
Injection site pain Injection site induration Injection site erythema Injection site swelling Injection site hemorrhage 
utrujenost pireksija mrzlica splošno slabo počutje gripi podobna bolezen nelagoden občutek v prsnem košu reakcije na mestu injiciranja
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.