FrancophonIA/ELRC3.0 huggingface dataset:
English: Influenza virus (whole virion, inactivated), containing antigen of*strain: A/Vietnam/1203/2004 (H5N1) 7.5 micrograms** * produced in Vero cells ** haemagglutinin
Croatian: Virus influence (cijeli virion, inaktivirani), koji sadrži antigen* soja: A/Vietnam/1203/2004 (H5N1) 7,5 mikrograma** * proizveden na Vero stanicama ** hemaglutinin
English: After first opening, the vaccine should be used immediately (within 3 hours maximum).
Croatian: Nakon prvog otvaranja, cjepivo je potrebno odmah primijeniti (u roku od najviše 3 sata).
English: VEPACEL is presented as a suspension for injection in a pre-filled syringe.
Croatian: VEPACEL je dostupan kao suspenzija za injekciju u napunjenoj štrcaljki.
English: VEPACEL has minor influence on the ability to drive and use machines.
Croatian: VEPACEL malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: There are no data on co-administration of VEPACEL with other vaccines.
Croatian: Nema podataka o istovremenoj primjeni VEPACELA s drugim cjepivima.
English: Somnolence Hypoaesthesia
Croatian: Omaglica Somnolencija
English: A protective immune response may not be induced in all individuals receiving the vaccine (see section 5.1).
Croatian: Zaštitna imunološka reakcija možda neće biti izazvana u svih pojedinaca koji primaju cjepivo
English: 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:
Croatian: Nakon prvog cijepljenja, stopa ispitanika s neutralizirajućim titrima protutijela >20, stopa serokonverzije i faktor serokonverzije, određeni testom mikroneutralizacije (MN) u ispitanika od 18 do 59 godina i starijih osoba od 60 i više godina, bili su sljedeći:
English: • flu-like illness
Croatian: • bolest slična gripi
English: Infants, children and adolescents from the age of 6 months to 17 years and adults from the age of 18 years:
Croatian: Dojenčad, djeca i adolescenti u dobi od 6 mjeseci do 17 godina i odrasli u dobi od 18 i više godina: Primjenjuje se jedna doza od 0,5 ml.
English: 12 - 24 months booster
Croatian: 12 do 24-mjesečni booster * MN titar ≥ 20
English: Very rare (affects less than 1 user in 10,000):
Croatian: Vrlo rijetko (javlja se kod manje od 1 na 10 000 korisnika):
English: VEPACEL must not be administered intravascularly.
Croatian: VEPACEL se ne smije primjenjivati intravaskularno.
English: Multidose vial (10 doses of 0.5 ml per vial)
Croatian: Višedozna bočica (10 doza od 0,5 ml po bočici)
English: B. PACKAGE LEAFLET
Croatian: b) Tablični popis nuspojava
English: However, if this cannot be avoided, the other vaccine should not be injected into the same arm used for VEPACEL.
Croatian: drugo se cjepivo ne smije injicirati u istu ruku u koju je primijenjen VEPACEL.
English: • eye irritation
Croatian: • nadrženost oka
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Croatian: Prolazni lažno pozitivni rezultati mogući su zbog stvaranja
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL - SINGLE DOSE PRE-FILLED SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA - JEDNODOZNA NAPUNJENA ŠTRCALJKA
English: 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.
Croatian: Reakcije preosjetljivosti, uključujući anafilaksiju, zabilježene su nakon primjene sličnog cjelovirionskog cjepiva protiv influence H1N1 proizvedenog na kulturi Vero stanica koje je primijenjeno tijekom razdoblja pandemije.
English: Tested against
Croatian: Određeno na
English: • vertigo (a spinning sensation)
Croatian: • vrtoglavica (osjećaj vrtenja)
English: 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.
Croatian: Imunogenost cjepiva soja A/Vietnam/1203/2004 procijenjena je u tri klinička ispitivanja u odraslih u dobi od 18 do 59 godina (N=961) te u dva klinička ispitivanja u ispitanika u dobi od 60 i više godina (N=391), nakon primjene 0. i 21. dana.
English: • hardness, redness, swelling or bruising at the injection site
Croatian: • otvrdnuće, crvenilo, oteknuće ili modrice na mjestu injekcije
English: Common (affects 1 to 10 users in 100):
Croatian: Često (javlja se kod 1 do 10 na 100 korisnika):
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA BOČICU S 10 DOZA
English: No case of overdose has been reported for VEPACEL.
Croatian: 4.9 Predoziranje Nisu prijavljeni slučajevi predoziranja VEPACELOM.
English: • fatigue (feeling tired)
Croatian: • iscrpljenost (osjećaj umora)
English: Influenza virus (whole virion, inactivated) containing antigen of strain: A/Vietnam/1203/2004 (H5N1)
Croatian: Virus influence (cijeli virion, inaktivirani) koji sadrži antigen soja: A/Vietnam/1203/2004 (H5N1)
English: Influenza virus (whole virion, inactivated), containing antigen* of strain: A/Vietnam/1203/2004 (H5N1)
Croatian: Virus influence (cijeli virion, inaktivirani), koji sadrži antigen* soja: A/Vietnam/1203/2004 (H5N1)
English: 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).
Croatian: Heterologno booster cijepljenje sa 7,5 µg neadjuventirane formulacije cjepiva soja A/Indonesia/05/2005 primijenjeno je u vremenskom razdoblju od 12 mjeseci nakon primarnog cijepljenja s dvije doze cjepiva soja A/Vietnam/1203/2004 u djece i adolescenata u dobi od 9 do 17 godina (N=196), djece u dobi od 3 do 8 godina (N=79) i u dojenčadi i djece u dobi od 6 do 35 mjeseci (N=25).
English: - if you have a weakened immune system as for example because of immunosuppressive therapy, e.g. taking of corticosteroids or treatment for cancer.
Croatian: Takve su se reakcije pojavile i u bolesnika s više alergija i u bolesnika bez poznatih alergija. - ako imate oslabljen imunološki sustav, na primjer, zbog imunosupresijske terapije kao što je uzimanje kortikosteroida ili kemoterapija zbog raka; - ako imate problema s krvarenjem ili lako dobijete modrice.
English: NAME OF THE MEDICINAL PRODUCT VEPACEL suspension for injection in pre-filled syringe Prepandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Croatian: Cjepivo protiv prepandemijske influence (H5N1) (cijeli virion, iz staničnih kultura), inaktivirano
English: 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:
Croatian: Nakon cijepljenja stopa ispitanika s neutralizirajućim titrima protutijela ≥ 20, stopa serokonverzije i faktor serokonverzije određeni testom mikroneutralizacije (MN) u imunokompromitiranih ispitanika i bolesnika s kroničnim bolestima, bili su sljedeći:
English: Sodium chloride Water for injections Polysorbate 80.
Croatian: Drugi sastojci su trometamol natrijev klorid voda za injekcije polisorbat 80.
English: Rare (affects 1 to 10 users in 10,000):
Croatian: Rijetko (javlja se kod 1 do 10 na 10 000 korisnika):
English: • bruising at the injection site
Croatian: • svrbež na mjestu injekcije
English: 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:
Croatian: Nakon cijepljenja, stopa ispitanika s titrom neutralizirajućih protutijela ≥ 20, stopa serokonverzije i faktor serokonverzije izmjereni mikroneutralizacijskom analizom (MN) u dojenčadi, djece i adolescenata u dobi od 6 mjeseci do 17 godina bili su sljedeći: Mikroneutralizacijska analiza
English: Very common (affects more than 1 user in 10):
Croatian: Vrlo često (javlja se kod više od 1 na 10 korisnika):
English: Injection Site Reactions
Croatian: OPĆI POREMEĆAJI I REAKCIJE NA MJESTU PRIMJENE
English: • swollen glands
Croatian: • otečene žlijezde
English: A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered in a time frame of 12 to 24 months after priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical studies in adults aged 18 to 59 years and in older people aged 60 years and above.
Croatian: Heterologno booster-cijepljenje sa 7,5 µg neadjuventirane formulacije cjepiva sa sojem A/Indonesia/05/2005, primijenjeno je u vremenskom okviru od 12 do 24 mjeseca nakon primarnog cijepljenja s dvije doze cjepiva soja A/Vietnam/1203/2004 u tri klinička ispitivanja u odraslih osoba u dobi od 18 do 59 godina i starijih osoba od 60 i više godina.
English: Dyspnea
Croatian: Dispepsija
English: - If you get any of the side effects, talk to your doctor or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: • pain in the armpit
Croatian: • bol u trbuhu
English: Seroneutralisation rate* Immunocompromised subjects Patients with chronic disease conditions Tested against
Croatian: Stopa seroneutralizacije* Imunokompromitirani ispitanici
English: 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:
Croatian: Stope seroneutralizacije (MN titar ≥ 20) 21 dan nakon booster cijepljenja dozom od 7,5 µg cjepiva soja A/Indonesia/05/2005, ispitani na homologne i heterologne sojeve bile su sljedeće:
English: If you get any side effects talk to your doctor or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili medicinsku sestru.
English: Malaise
Croatian: POREMEĆAJI
English: Conjunctivitis Eye irritation
Croatian: Konjuktivitis Iritacija oka
English: 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.
Croatian: Booster sa 7,5 µg neadjuventirane formulacije cjepiva sa sojem A/Indonesia/05/2005, primijenjen 12 mjeseci nakon jedne doze primarnog cjepiva sa sojem A/Vietnam/1203/2004 također je procijenjen u odraslih osoba u dobi od 18 do 59 godina.
English: Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 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:
Croatian: Stope seroneutralizacije (MN titar ≥ 20) 21 dan nakon 12 do 24-mjesečnog booster-cijepljenja dozom od 7,5 µg cjepiva soja A/Indonesia/05/2005, određene i na homologne i heterologne sojeve, bile su sljedeće:
English: 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.
Croatian: Imunogenost cjepiva protiv soja A/Vietnam/1203/2004 procijenjena je u kliničkom ispitivanju u djece i adolescenata u dobi od 9 do 17 godina (N=288), u djece u dobi od 3 do 8 godina (N=146)
English: Vomiting Diarrhoea
Croatian: POREMEĆAJI METABOLIZMA
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 dose (0.5 ml) contains:
Croatian: TVARI 1 doza (0,5 ml) sadrži:
English: Dublin 2
Croatian: DODATAK II
English: EXP After first opening, use immediately (within 3 hours max)
Croatian: Nakon prvog otvaranja odmah primijeniti (u roku od najviše 3 sata)
English: 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:
Croatian: Stope seroneutralizacije (MN titar ≥ 20) 21 dan nakon 12-mjesečnog booster-cijepljenja dozom od 7,5 µg cjepiva soja A/Indonesia/05/2005, određene i na homologne i heterologne sojeve bile su sljedeće:
English: Very common (affects more than 1 user in 10): • pain at the injection site
Croatian: Vrlo često (javlja se kod više od 1 na 10 korisnika): • pospanost
English: Manufacturer
Croatian: SUSTAVA
English: ** ≥ 4-fold increase in MN titer *** geometric mean increase
Croatian: *** geometrijska srednja vrijednost povećanja
English: MARKETING AUTHORISATION NUMBER EU/1/12/752/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/752/001
English: ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača biološke(ih) djelatne(ih) tvari Baxter BioScience s.r.o.
English: Nasal congestion Rhinorrhea Dry throat
Croatian: Kongestija nosa Rinoreja
English: MARKETING AUTHORISATION NUMBER EU/1/12/752/002
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/752/002
English: There are no data with VEPACEL using the subcutaneous route.
Croatian: Nema podataka o supkutanoj primjeni VEPACELA.
English: Uncommon (affects 1 to 10 users in 1,000):
Croatian: Manje često (javlja se kod 1 do 10 na 1000 korisnika):
English: Seroneutralisation rate* Tested against
Croatian: Stopa seroneutralizacije* Određeno na
English: Seroneutralisation rate*
Croatian: Stopa seroneutrali zacije *
English: There are no post-marketing surveillance data available for VEPACEL.
Croatian: • Praćenje nakon stavljanja u promet Nema dostupnih podataka o praćenju VEPACELA nakon stavljanja u promet.
English: • pain at the injection site
Croatian: • bol na mjestu injekcije
English: This leaflet was last revised in
Croatian: Ove nuspojave mogu se pojaviti nakon primjene
English: Injection site pain Injection site induration Injection site erythema Injection site swelling Injection site hemorrhage
Croatian: • Krvarenje na mjestu injekcije • Iritacija na mjestu injekcije
English: Chest discomfort
Croatian: OPĆI POREMEĆAJI
English: Ear pain
Croatian: Bol u pazuhu
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection
Croatian: Uputa o lijeku: Informacija za korisnika VEPACEL suspenzija za injekciju
English: EXPIRY DATE
Croatian: Ispitan na
English: • Injection site hemorrhage
Croatian: Hemoragija na mjestu injiciranja
English: SUBCUTANEOUS TISSUE DISORDERS
Croatian: POREMEĆAJI KOŽE I POTKOŽNOG TKIVA
English: NAME OF THE MEDICINAL PRODUCT VEPACEL
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Fatigue Pyrexia Chills
Croatian: Osip Urtikarija
English: HTLV-1.
Croatian: IgM-a na cjepivo.
English: Hyperhidrosis Pruritus
Croatian: Heterologna booster-cijepljenja
English: EYE DISORDERs
Croatian: POREMEĆAJI OKA
English: • rash, hives
Croatian: • osip, koprivnjača
English: • Injection site induration
Croatian: • svrbež na mjestu injiciranja
English: 1 pre-filled syringe (0.5 ml)
Croatian: OBLIK I SADRŽAJ Suspenzija za injekciju 1 napunjena štrcaljka (0,5 ml)
English: - if you have had any allergic reaction to any ingredient of the vaccine (see section 6 at the end of the leaflet) or trace residues (formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein).
Croatian: Manja infekcija kao što je prehlada ne bi trebala biti problem, no liječnik bi Vas trebao savjetovati možete li primiti VEPACEL. - ako ste imali bilo koju alergijsku reakciju na bilo koji sastojak cjepiva (vidjeti dio 6 na kraju uputa) ili na ostatne tvari u tragovima (formaldehid, benzonazu, saharozu, tripsin, proteine Vero stanice domaćina).
English: The frequency of this type of event is not known (cannot be estimated from available data).
Croatian: Učestalost ove vrste događaja nije poznata (ne može se procijeniti iz dostupnih podataka).
English: For any information about this medicine, please contact the Manufacturer:
Croatian: Za sve informacije o ovom lijeku obratite se proizvođaču:
English: Read all of this leaflet carefully before this medicine is used to treat you, because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego što Vam primijene ovaj lijek jer sadrži Vama važne podatke.
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka mora se primijeniti standardno medicinsko liječenje za šok.
English: At the Cmax, the plasma concentration represented only 1 to 2% of the applied dose.
Croatian: Pri Cmax, plazmatska koncentracija predstavlja samo 1 do 2% primijenjene doze.
English: EVARREST is not recommended for use in children and adolescents under 18 years of age.
Croatian: EVARREST se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
English: Such substances should be removed to the greatest possible extent before applying the product.
Croatian: Takve tvari se moraju ukloniti u najvećoj mogućoj mjeri prije nanošenja lijeka.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29 September 2013
Croatian: Datum prvog odobrenja: 29. rujna 2013.
English: In isolated cases, these reactions have progressed to severe anaphylaxis.
Croatian: U izoliranim slučajevima ove su reakcije napredovale do teške anafilaksije.
English: The safety and efficacy of EVARREST in children from birth to 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka EVARREST u djece u dobi od rođenja do 18 godina nije još ustanovljena.
English: These include:
Croatian: Te mjere uključuju:
English: - for improvement of haemostasis.
Croatian: - za poboljšanje hemostaze.
English: ● EVARREST must not be applied intravascularly.
Croatian: ● EVARREST se ne smije primjenjivati intravaskularno.
English: 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).
Croatian: Sljedeće kategorije korištene su za svrstavanje nuspojava prema učestalosti pojavljivanja: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); i vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Talk to your surgeon before you are treated with EVARREST.
Croatian: Obratite se svom kirurgu prije nego Vam primjeni EVARREST.
English: All adverse reactions reported during the clinical trials occurred at a frequency of less than 1% (uncommon).
Croatian: Sve nuspojave prijavljene tijekom kliničkog ispitivanja javile su se pri učestalosti manjoj od 1 % (manje često).
English: As a consequence, intravascular pharmacokinetic studies were not performed in man.
Croatian: Zbog toga nisu provedena intravaskularna farmakokinetička ispitivanja na ljudima.
English: UNIQUE IDENTIFIER-2DBARCODE 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom.
English: 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).
Croatian: EVARREST se ne smije primijeniti na Vama ako ste alergični na humani fibrinogen ili humani trombin ili na neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Transmission of infectious agents
Croatian: Prijenos infektivnih uzročnika
English: EVARREST must not be stored above 25°C and must not be frozen.
Croatian: EVARREST se ne smije čuvati na temperaturi iznad 25 °C i ne smije se zamrzavati.
English: In animal studies EVARREST was absorbed by 56 days when used at the anticipated clinical dose.
Croatian: U ispitivanjima na životinjama EVARREST je apsorbiran za 56 dana kada se primjenjivao u očekivanoj kliničkoj dozi.
English: EVARREST must be kept dry at all times prior to application to avoid pre-activation.
Croatian: EVARREST se mora držati suhim cijelo vrijeme prije primjene kako bi se izbjegla njegova prijevremena aktivacija.
English: What EVARREST is and what it is used for 2.
Croatian: Što je EVARREST i za što se koristi 2.
English: The following adverse events which occurred during clinical studies were considered to be related to the use of EVARREST:
Croatian: Za sljedeće štetne događaje koji su uočeni tijekom kliničkih ispitivanja smatra se da su povezani s primjenom lijeka EVARREST:
English: The safety of fibrin sealants/haemostatics for use in human pregnancy or during breast-feeding has not been established in controlled clinical trials.
Croatian: Sigurnost fibrinskih tkivnih ljepila/hemostatika za primjenu u ljudi tijekom trudnoće ili dojenja nije utvrđena u kontroliranim kliničkim ispitivanjima.
English: Study subjects were followed post-operatively through discharge and at Day 30 (+/-14 days) post discharge.
Croatian: Ispitanici su praćeni nakon kirurškog zahvata do otpuštanja i na Dan 30 (+/-14 dana) nakon otpusta.
English: Do not apply intravascularly
Croatian: Nemojte primjenjivati intravaskularno.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Croatian: Ova uputa o lijeku je dostupna je na svim jezicima EU/EGP-a na internetskimj stranicama Europske agencije za lijekove.
English: 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.
Croatian: Prirodno cijeljenje događa se kad se fibrin razgrađuje, a tijelo resorbira proizvod; smatra se da resorpcija traje približno 8 tjedana kako je to dokazano na životinjskim modelima glodavaca i svinje.
English: Pharmacotherapeutic group: antihaemorrhagics, local haemostatics, ATC code: B02BC30
Croatian: Farmakoterapijska skupina: Antihemoragici, lokalni hemostatici, ATK oznaka: B02BC30
English: What EVARREST looks like and contents of the pack
Croatian: Kako EVARREST izgleda i sadržaj pakiranja
English: Most Serious Side Effects Bleeding (haemorrhage)
Croatian: Najozbiljnije nuspojave Krvarenje (hemoragija)
English: None of the patients in any treatment group had a significant change in antibody titre to thrombin or fibrinogen.
Croatian: Niti jedan od bolesnika u bilo kojoj ispitivanoj skupini nije imao značajnu promjenu u razini titra protutijela na trombin ili fibrinogen.
English: This also applies to any unknown or emerging viruses, or other types of infections.
Croatian: To se također odnosi na sve nepoznate viruse ili one u nastajanju ili druge tipove infekcija.
English: Maintain compression for approximately 3 minutes, to control the bleeding.
Croatian: Zadržite kompresiju tijekom približno 3 minute kako biste kontrolirali krvarenje.
English: 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.
Croatian: Uporabom 125Itrombina dokazano je da spora apsorpcija biološki inaktivnih peptida kao rezultat razgradnje trombina doseže Cmax u plazmi nakon 6 do 8 sati.