FrancophonIA/ELRC3.0 huggingface dataset:
English: Visually inspect the suspension prior to administration.
Croatian: Vizualno pregledati suspenziju prije primjene.
English: You should be aware that side effects may be intensified.
Croatian: Budite svjesni da bi se nuspojave mogle pojačati.
English: The A/Vietnam/1203/2004 vaccine afforded protection against homologous challenge as evidenced by full survival, reduced weight loss, a less pronounced and shorter increase in temperature, a less marked reduction in lymphocyte counts and in reduction of inflammation and necrosis in brain and olfactory bulb in the vaccinated cohorts as compared to control animals.
Croatian: Cjepivo A/Vietnam/1203/2004 pružilo je zaštitu od infekcije homolognim sojem, što se očitovalo potpunim preživljenjem, smanjenim gubitkom težine, manje naglašenim i kraćim povećanjem temperature, manje primjetnim smanjenjem broja limfocita i smanjenjem upale i nekroze mozga i olfaktornog bulbusa u cijepljenoj skupini u usporedbi s kontrolnim životinjama.
English: Non-clinical studies demonstrated minor alterations in liver enzymes and calcium levels in a repeat dose toxicity study in rats.
Croatian: Neklinička ispitivanja pokazala su manje promjene razine jetrenih enzima i kalcija, u ispitivanju toksičnosti ponovljenih doza na štakorima.
English: Seroneutralization rate* 52.6% 85.4% 17.1% 72.9% 3.0% 68.8% Seroconversion rate** 9.1% 31.8% 16.4% 72.2% 9.1% 65.6% Seroconversion factor***
Croatian: 2.doza Stopa seroneutralizacije* 52,6% 85,4% 17,1% 72,9% 3,0% 68,8% Stopa serokonverzije** Faktorserokonverzije*** * MN titar ≥ 20 ** ≥ 4-struko povećanje u MN titru
English: This section describes the clinical experience with the H5N1 vaccine.
Croatian: Ovaj dio opisuje kliničko iskustvo s cjepivom protiv virusa H5N1.
English: The safety of VEPACEL in pregnancy and lactation has not been assessed in clinical trials.
Croatian: Sigurnost VEPACELA tijekom trudnoće i dojenja nije procijenjena u kliničkim ispitivanjima.
English: If you need a blood test to look for evidence of infection with certain viruses in the first few weeks after vaccination with VEPACEL, the result of the test may not be correct.
Croatian: Ako trebate pretragu krvi radi potvrde infekcije određenim virusima u prvih nekoliko tjedana nakon cijepljenja VEPACELOM, nalaz pretrage možda neće biti točan.
English: • 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.
Croatian: • pojačano znojenje • otvrdnuće, crvenilo, oticanje ili stvaranje modrica na mjestu injiciranja b) Sljedeće su nuspojave zabilježene u kliničkim ispitivanjima u djece u dobi od 3 do 8 godina.
English: Animal studies with H5N1 strain vaccines (A/Vietnam/1203/2004 and A/Indonesia/05/2005) do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Croatian: Ispitivanja na životinjama cjepivima soja H5N1 (A/Vietnam/1203/2004 i A/Indonesia/05/2005) ne upućuju na izravne ili neizravne štetne učinke na plodnost, trudnoću, embrionalni/fetalni razvoj, porođaj ili postnatalni razvoj (vidjeti dio 5.3).
English: Following influenza vaccination, false positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus, and especially, HTLV-1.
Croatian: Nakon cijepljenja protiv influence, mogu se dobiti lažno pozitivni rezultati seroloških testiranja metodom ELISA na protutijelo protiv virusa humane imunodeficijencije -1 (HIV-1), hepatitisa C i posebno HTLV-1.
English: Neurological disorders, such as encephalomyelitis, neuritis, and Guillain Barré syndrome.
Croatian: Neurološki poremećaji, kao što su encefalomijelitis, neuritis i Guillain Barréov sindrom.
English: VEPACEL should not be given at the same time as immunoglobulins.
Croatian: VEPACEL se ne smije primiti istovremeno s imunoglobulinima.
English: • vasculitis (inflammation of blood vessels which can cause skin rashes, joint pain and kidney problems)
Croatian: • vaskulitis (upala krvnih žila koja može uzrokovati kožne osipe, bol u zglobovima i probleme s bubrezima)
English: After shaking, the vaccine is a clear to opalescent suspension.
Croatian: Nakon što ga protresete, cjepivo je bistra do opalescentna suspenzija.
English: Rare: neuralgia, transient thrombocytopenia.
Croatian: Rijetko: neuralgija, prolazna trombocitopenija.
English: Adverse Reactions (adults and older people)
Croatian: Nuspojave (odrasli i starije osobe)
English: PSUR submission when VEPACEL is used during an influenza pandemic:
Croatian: Podnošenje PSUR-a kad se VEPACEL koristi tijekom pandemije influence:
English: Immune system disorders: anaphylactic reaction, hypersensitivity Nervous system disorders: febrile convulsion Skin and subcutaneous tissue disorders: angioedema Muscoluskeletal and connective tissue disorders: pain in extremity
Croatian: Poremećaji imunološkog sustava: anafilaktička reakcija, preosjetljivost Poremećaji živčanog sustava: febrilne konvulzije Poremećaji kože i potkožnog tkiva: angioedem Poremećaji mišićno-koštanog i vezivnog tkiva: bol u udovima
English: In a clinical trial 300 adolescents aged 9 to 17 years and 153 children aged 3 to 8 years were administered the H5N1 vaccine.
Croatian: U kliničkom ispitivanju 300 adolescenata u dobi od 9 do 17 godina i 153 djece u dobi od 3 do 8 godina primilo je cjepivo H5N1.
English: Side effects observed with flu vaccines given routinely every year In the days or weeks after vaccination with vaccines given routinely every year to prevent flu, the side effects listed below have occurred.
Croatian: U danima ili tjednima nakon cijepljenja cjepivima koja se rutinski daju svake godine radi sprječavanja gripe pojavile su se nuspojave navedene u nastavku.
English: The adverse reactions observed are shown in the table below.
Croatian: Zabilježene nuspojave prikazane su u donjoj tablici.
English: • low blood platelet count which can result in bleeding or bruising
Croatian: • nizak broj trombocita koji može uzrokovati krvarenje ili modrice
English: However, if this cannot be avoided, the immunoglobulins should not be injected into the same arm used for VEPACEL.
Croatian: Međutim, ako se to ne može izbjeći, imunoglobulini se ne smiju injicirati u istu ruku u koju je primijenjen VEPACEL.
English: The incidence and nature of symptoms after the first and second vaccination were similar to those observed in the healthy adults and older people.
Croatian: Incidencija i priroda simptoma nakon prvog i drugog cijepljenja bile su slične onima opaženima kod zdravih odraslih i starijih osoba.
English: The protective efficacy of VEPACEL against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian influenza H5N1 virus was assessed non-clinically in a ferret challenge model.
Croatian: Djelotvornost zaštite VEPACELA protiv morbiditeta i mortaliteta od infekcija izazvanih letalnim dozama iznimno patogenog virusa ptičje gripe H5N1 procijenjena je neklinički na modelu izlaganja tvorova.
English: • conjunctivitis (an inflammation of the eye), eye irritation
Croatian: • konjunktivitis (upala oka), iritacija oka
English: There were fewer side effects after the second vaccination compared with the first.
Croatian: Nakon drugog cijepljenja zabilježeno je manje nuspojava u usporedbi s prvim cijepljenjem.
English: The side effects are generally similar to those related to the flu vaccine.
Croatian: Nuspojave su u pravilu slične onima povezanim s cjepivom protiv gripe.
English: A second dose of 0.5 ml should be given after an interval of at least three weeks.
Croatian: Drugu dozu od 0,5 ml treba primijeniti nakon intervala od najmanje tri tjedna.
English: You should not receive VEPACEL
Croatian: Nemojte primiti VEPACEL
English: What VEPACEL looks like and contents of the pack
Croatian: Što VEPACEL izgleda i sadržaj pakiranja
English: NERVOUS SYSTEM DISORDERS
Croatian: POREMEĆAJI ŽIVČANOG SUSTAVA
English: Preferred MedDRA Term
Croatian: MedDRA preporučeni naziv
English: Active immunisation against H5N1 subtype of influenza A virus.
Croatian: Aktivna imunizacija protiv podtipa H5N1 virusa influence A.
English: Each dose of 0.5 ml is withdrawn into a syringe for injection.
Croatian: Svaka doza od 0,5 ml povlači se u štrcaljku za injekciju.
English: • allergic reactions, including anaphylactic reactions leading to a dangerous decrease in blood pressure which, if untreated, may lead to shock
Croatian: • alergijske reakcije, uključujući anafilaktičke reakcije koje dovode do opasnog smanjenja krvnog tlaka, što, ako se ne liječi, može dovesti do šoka.
English: a) The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
Croatian: a) Sljedeće su nuspojave zabilježene u kliničkim ispitivanjima u dojenčadi u dobi od 6 do 35 mjeseci.
English: * produced in Vero cells ** haemagglutinin
Croatian: * proizveden na Vero stanicama ** hemaglutinina
English: There is no information on the use of VEPACEL under the skin.
Croatian: Ne postoje podaci o primjeni VEPACELA pod kožu.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Croatian: Kao kod svih cjepiva koji se injiciraju, odgovarajuće medicinsko liječenje i nadzor uvijek trebaju biti dostupni u slučaju rijetke anafilaktičke reakcije nakon primjene cjepiva.
English: • Infants, children, and adolescents
Croatian: • Dojenčad, djeca i adolescenti
English: After first opening, the vaccine should be used immediately.
Croatian: Nakon prvog otvaranja, cjepivo je potrebno odmah primijeniti.
English: VEPACEL is a vaccine for use in individuals aged 6 months and older.
Croatian: VEPACEL je cjepivo koje se koristi u osoba u dobi od 6 mjeseci i više.
English: PEEL OFF´S (1 PEEL OFF PER DOSIS)
Croatian: ODVOJIVA NALJEPNICA (1 ODVOJIVA NALJEPNICA PO DOZI)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 doza (0,5 ml) sadrži:
English: Prepandemic influenza vaccine (H5N1)
Croatian: Cjepivo protiv prepandemijske influence (H5N1)
English: Clear to opalescent suspension.
Croatian: Bistra do opalescentna suspenzija.
English: Immunisation should be carried out by intramuscular injection into the deltoid muscle or anterolateral thigh, depending on the muscle mass.
Croatian: Imunizacija se provodi intramuskularnom injekcijom u deltoidni mišić ili anterolateralno područje bedra, ovisno o mišićnoj masi.
English: • stomach pain, upset stomach
Croatian: • bol u trbuhu, nadražen želudac
English: How VEPACEL is given
Croatian: Kako se VEPACEL daje
English: The immunological response may be diminished if the patient is undergoing treatment with immunosuppressants.
Croatian: Imunološki odgovor može biti smanjen u bolesnika na imunosupresivnoj terapiji.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 17/02/2012
Croatian: Datum prvog odobrenja: 17. 02. 2012.
English: 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.
Croatian: Nadalje, tijekom pandemije, resursi potrebni za dubinsku procjenu Periodičkih izvješća o neškodljivosti lijeka u formatu definiranom u Volumenu 9a Pravilnika koji uređuje lijekove u Europskoj
English: Immunogenicity in adults aged 18 to 59 years (N=961) and in subjects aged 60 years and older (N=391)
Croatian: Imunogenost u ispitanika od 18 do 59 godina (N=961) i u ispitanika od 60 i više godina (N=391)
English: From post-marketing surveillance with a whole virion, Vero cell derived, H1N1 vaccine, the following adverse reactions have been reported (the frequency of these adverse reactions is not known as it cannot be estimated from the available data):
Croatian: Na temelju praćenja cjelovirionskog cjepiva H1N1 proizvedenog na kulturi Vero stanica, nakon stavljanja u promet, zabilježene su sljedeće nuspojave (učestalost tih nuspojava nije poznata jer se ne može procijeniti iz dostupnih podataka):
English: The vaccine will be injected into the muscle of the upper arm (deltoid muscle) or upper thigh, depending on the muscle mass.
Croatian: Cjepivo će se injicirati u mišić nadlaktice (deltoidni mišić) ili gornji dio bedra, ovisno o mišićnoj masi.
English: All ferrets were challenged intranasally on day 35 with a high dose of the highly virulent H5N1 virus strain A/Vietnam/1203/2004 and monitored for 14 days.
Croatian: Svi su tvorovi 35. dana inficirani intranazalno visokom dozom visoko virulentnog soja virusa H5N1 A/Vietnam/1203/2004 te su praćeni 14 dana.
English: In the clinical studies conducted in infants, children and adolescents, the incidence and nature of symptoms after the first and second vaccination were similar to those occurred in adults and older people.
Croatian: U kliničkim ispitivanjima provedenim na dojenčadi, djeci i adolescentima, učestalost i priroda simptoma nakon prvog i drugog cijepljenja bili su slični onima koji su se pojavili u odraslih osoba i starijih osoba.
English: These side effects may occur with VEPACEL.
Croatian: Ove nuspojave mogu se pojaviti nakon primjene VEPACELA.
English: A 12 to 24 months heterologous booster has also been administered in a phase 3 study in immunocompromised subjects and patients with chronic disease conditions.
Croatian: Heterologni booster također je primijenjen nakon 12 mjeseci do 24 mjeseca u fazi 3 ispitivanja u imunokompromitiranih ispitanika i bolesnika s kroničnim bolestima.
English: • injection-site reaction such as irritation, itching, bruising or stiff arm
Croatian: • reakcije na mjestu injekcije kao što su iritacija, svrbež, stvaranje modrica ili ukočena ruka
English: ACTIVE SUBSTANCE A/Vietnam/1203/2004 (H5N1)
Croatian: DJELATNA TVAR A/Vietnam/1203/2004 (H5N1)
English: 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.
Croatian: Klinička ispitivanja cjepiva H5N1 (vidjeti dio 5.1. za dodatne informacije o cjepivima H5N1) provedena su na približno 3700 ispitanika (u dobnim skupinama od 18 do 59 godina i 60 godina i više godina) i posebnim rizičnim skupinama od približno 300 ispitanika u svakoj skupini, koje su se sastojale od imunokompromitiranih ispitanika i bolesnika s kroničnim bolestima.
English: • allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated,
Croatian: • alergijske reakcije koje dovode do opasnog smanjenja krvnog tlaka, što, ako se ne liječi, može dovesti do šoka.
English: Side effects observed with a similar influenza vaccine (Celvapan) The side effects listed below have occurred with a similar influenza vaccine (Celvapan) in adults and children during the H1N1 pandemic flu vaccination programme:
Croatian: Nuspojave zabilježene kod sličnog cjepiva protiv influence (Celvapan) Nuspojave navedene u nastavku pojavile su se nakon primjene sličnog cjepiva protiv influence (Celvapan) u odraslih i djece tijekom programa cijepljenja protiv pandemijske gripe H1N1:
English: Immunogenicity in immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123)
Croatian: Imunogenost u imunokompromitiranih ispitanika (N=122) i bolesnika s kroničnim bolestima (N=123)
English: - if you have previously had a severe allergic reaction to any ingredient of VEPACEL (these are listed at the end of the leaflet - section 6) or to any substances that may be present in trace (very low) amounts: formaldehyde, benzonase, sucrose, trypsin, Vero host cell protein.
Croatian: - ako ste prethodno imali tešku alergijsku reakciju na bilo koji sastojak VEPACELA (isti su navedeni na kraju uputa - dio 6) ili na bilo koju tvar koja može biti prisutna u tragovima (vrlo malim količinama): formaldehid, benzonazu, saharozu, tripsin, proteine Vero stanice domaćina.
English: One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Croatian: Jedno pakiranje od 20 višedoznih bočica (staklo tipa I) s 5 ml suspenzije (10 doza x 0,5 ml) s čepom (bromobutilna guma).
English: • malaise (generally feeling unwell)
Croatian: • slabost (općenito loše osjećanje)
English: In addition, the immunogenicity has also been evaluated in a Phase 3 study in specified risk groups of immunocompromised subjects (N=122) and patients with chronic disease conditions (N=123) following a 0, 21 day schedule.
Croatian: Nadalje, imunogenost je također procijenjena u fazi 3 ispitivanju, u specifičnim rizičnim skupinama imunokompromitiranih ispitanika (N=122) i bolesnika s kroničnim bolestima (N=123) nakon primjene 0. i 21. dana.
English: The vaccine should never be given into a blood vessel.
Croatian: Cjepivo se nikad ne smije primijeniti u krvnu žilu.
English: 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.
Croatian: VEPACEL je dostupan kao suspenzija za injekciju u višedoznoj bočici (10 doza od 0,5 ml po bočici) u pakiranjima veličine od 20 bočica.
English: Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Croatian: Stvaranje protutijela u bolesnika s endogenom ili jatrogenom imunosupresijom može biti nedostatno.
English: VEPACEL may affect your ability to drive and use machines.
Croatian: VEPACEL može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Ology Bioservices Ireland LTD Wilton Park House Wilton Place
Croatian: Wilton Park House Wilton Place Dablin 2
English: neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
Croatian: • neurološki poremećaji kao što su encefalomijelitis (upala središnjeg živčanog sustava), neuritis (upala živaca) i vrsta paralize poznata kao Guillain-Barréov sindrom
English: 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.
Croatian: Alergijske reakcije, uključujući nagle i po život opasne alergijske reakcije (anafilaksa) prijavljene su nakon primjene sličnog cjepiva protiv influence H1N1 tijekom razdoblja pandemije.
English: 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).
Croatian: Anamneza anafilaktičkih reakcija na djelatnu tvar, ili na bilo koju od pomoćnih tvari navedenih u dijelu 6.1, ili na ostatne tvari u tragovima (formaldehid, benzonazu, saharozu, tripsin, proteine Vero stanice domaćina).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Pre-filled syringe (0.5ml)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Napunjena štrcaljka (0,5ml)
English: The following serious adverse reactions have been reported from post-marketing surveillance with egg-derived interpandemic trivalent vaccines:
Croatian: Trivalentna cjepiva protiv sezonske influence Sljedeće su ozbiljne nuspojave zabilježene kod interpandemijskih trivalentnih cjepiva proizvedenih na jajima, nakon stavljanja u promet:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Višedozna bočica (10 doza od 0,5 ml)
English: 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.
Croatian: 1 pakiranje s napunjenom štrcaljkom koja sadrži jednu dozu od 0,5 ml suspenzije za injekciju s klipom koji ne sadrži lateks (halogen-butil-guma) bez igala.
English: Trometamol Sodium Chloride Water for injections Polysorbate 80
Croatian: trometamol natrijev klorid voda za injekcije polisorbat 80
English: * MN titer ≥ 20
Croatian: 12-mjesečni booster * MN titar ≥ 20
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEPACEL suspension for injection
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA VEPACEL suspenzija za injekciju
English: Adverse Reactions (infants, children and adolescents)
Croatian: Nuspojave (dojenčad, djeca i adolescenti)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 10 DOSE VIAL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - BOČICA S 10 DOZA
English: MINIMUM PARTICULARS ATTACHED TO THE OUTER CARTON OF MULTIDOSE CONTAINER AND PRE-FILLED SYRINGE
Croatian: MINIMALNI PODACI PRIČVRŠĆENI ZA VANJSKO PAKIRANJE VIŠEDOZNOG SPREMNIKA I NAPUNJENE ŠTRCALJKE
English: There are no post-marketing data available for VEPACEL.
Croatian: Nema dostupnih podataka za VEPACEL nakon stavljanja u promet.
English: • sudden hearing loss
Croatian: • iznenadan gubitak sluha
English: The observed adverse reactions from a paediatric clinical trial with the H5N1 vaccine are listed below.
Croatian: Nuspojave zabilježene u pedijatrijskom kliničkom ispitivanju cjepiva H5N1 navedene su niže.
English: After first opening, the vial is to be used within a maximum of 3 hours.
Croatian: Nakon prvog otvaranja bočica se mora iskoristiti u roku od najviše 3 sata.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre ≥ 20 ** ≥ 4-fold increase in MN titre *** geometric mean increase
Croatian: Stopa seroneutralizacije* Stopa serokonverzije** Faktor serokonverzije*** * MN titar ≥ 20 ** ≥ 4-struko povećanje u MN titru
English: • fits due to fever
Croatian: • grčevi uslijed vrućice
English: 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.
Croatian: Jedno pakiranje od 1 jednodozne napunjene štrcaljke (staklo tipa I) koja sadrži 0,5 ml suspenzije za injekciju, s čepom klipa bez lateksa (halogenobutilna guma), bez igala.
English: There is no information on administration of VEPACEL with other vaccines.
Croatian: Nema informacija o primjeni VEPACELA s drugim cjepivima.
English: 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:
Croatian: Križno reaktivni imunološki odgovor na srodne H5N1 sojeve U kliničkom ispitivanju u odraslih osoba u dobi od 18 do 59 godina (N=265) i u starijih osoba u dobi od 60 i više godina (N=270) nakon cijepljenja cjepivom soja A/Vietnam/1203/2004, stopa ispitanika s križno neutralizirajućim protutijelima određena analizom MN (titar ≥ 20) bila je sljedeća:
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog(ih) za puštanje serije lijeka u promet Baxter AG
English: 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.
Croatian: Šesnaest je tvorova podijeljeno u dvije kohorte te su cijepljeni 0. i 21. dan s 7,5 µg cjepiva A/Vietnam/1203/2004 ili su lažno cijepljeni.