FrancophonIA/ELRC3.0 huggingface dataset:
English: Following a 12-month booster vaccination with a licensed trivalent virosomal influenza vaccine for the 2010/2011 Northern hemisphere influenza season, seroprotection rates, seroconversion rates and serconversion factors (compared to pre-booster antibody levels) for the H1N1 component as measured by SRH and MN assays were as follows:
Croatian: Nakon 12-mjesečnog booster-cijepljenja odobrenim trivalentnim virosomnim cjepivom protiv influence za sezonu gripe sjeverne hemisfere 2010./2011., stupnjevi serozaštite, stupnjevi serokonverzije i čimbenici serokonverzije (u usporedbi s razinama protutijela prije boostera) za sastojak H1N1 izmjereni SRH i MN analizama bili su sljedeći:
English: Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling
Croatian: • Znakovi alergijske reakcije mogu uključivati kožni osip koji svrbi, nedostatak daha
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml per vial)
Croatian: 5. SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Višedozna bočica (10 doza od 0,5 ml po bočici)
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance(s), to any of the excipients and to trace residues e.g. formaldehyde, benzonase, or sucrose.
Croatian: Oprez je nužan pri davanju ovog cjepiva osobama s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju od pomoćnih tvari i na ostatne tvari u tragovima, npr. formaldehid, benzonazu ili saharozu.
English: Clinical trials were conducted with a version of Celvapan containing a H5N1 vaccine strain (see section 5.1) in approximately 3700 subjects (ranging in age from 18 to 60 years and above), and in special risk groups of approximately 300 subjects each, consisting of immune-compromised subjects and patients with chronic disease conditions.
Croatian: Provedena su klinička ispitivanja s verzijom Celvapana koja sadrži soj cjepiva H5N1 (vidjeti dio 5.1) na približno 3700 ispitanika (u dobi od 18 do 60 godina i starijima) i posebnim rizičnim skupinama od približno 300 ispitanika po svakoj, a koje su se sastojale od imunokompromitiranih ispitanika i pacijenata s kroničnim bolestima.
English: * propagated in Vero cells (continuous cell line of mammalian origin)
Croatian: * umnožen u Vero stanicama (kontinuirana stanična linija porijeklom od sisavaca)
English: The seroprotection rates, seroconversion rates and seroconversion factors reported in adults and older subjects were comparable with Celvapan (H1N1)v.
Croatian: Stupnjevi serozaštite, stupnjevi serokonverzije i čimbenici serokonverzije zabilježeni u odraslih i starijih ispitanika bili su usporedivi s Celvapanom (H1N1)v.
English: Possible side effects Like all medicines, Celvapan can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: None of the ingredients in the vaccine can
Croatian: Nijedan sastojak u cjepivu ne može izazvati gripu.
English: Celvapan (H1N1)v to healthy children aged 6 months to 17 years.
Croatian: (H1N1)v zdravoj djeci u dobi od 6 mjeseci do 17 godina.
English: * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin.
Croatian: * umnožen u Vero stanicama (kontinuirana stanična linija porijeklom od sisavaca) ** izraženo u mikrogramima hemaglutinina.
English: 20 multidose vials (10 doses per vial - 0.5 ml per dose)
Croatian: 20 višedoznih bočica (10 doza po bočici - 0,5 ml po dozi)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10-DOSE VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE NALJEPNICA ZA BOČICU OD 10 DOZA
English: Celvapan (H1N1)v to healthy adults aged 18 years and older.
Croatian: (H1N1)v zdravim odraslim osobama u dobi od 18 godina naviše.
English: • you have problems with your immune system, since your response to the vaccine may then be poor.
Croatian: • ako imate problema s imunološkim sustavom, jer zbog toga
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine.
Croatian: Anamneza anafilaktičke (tj. po život opasne) reakcije na bilo koje sastojke ili tvari u tragovima (npr. formaldehid, benzonaza, saharoza) ovog cjepiva.
English: These transitory false-positive results may be due to IgM production in response to the vaccine.
Croatian: Ovi prolazni lažno pozitivni rezultati mogu biti uzrokovani stvaranjem
English: This may include the provision by the MAH of stickers with invented name and batch number with each pack of the vaccine.
Croatian: To može značiti da bi Nositelj odobrenja trebao nabaviti naljepnice sa zaštićenim imenom i brojem serije uz svako
English: The side effects listed below have occurred with Celvapan (H1N1)v in clinical studies in adults, including older people.
Croatian: Nuspojave navedene u nastavku pojavile su se nakon primjene Celvapana (H1N1)v u kliničkim ispitivanjima u odraslih, uključujući starije osobe.
English: “Possible side effects” may affect your ability to drive or use
Croatian: Neke od nuspojava spomenutih u dijelu 4. ”Moguće nuspojave” mogu utjecati na Vašu sposobnost upravljanja vozilima i rada na strojevima.
English: INFECTIONS AND INFESTATIONS Nasopharyngitis
Croatian: INFEKCIJE I INFESTACIJE
English: Children aged 6 months to 5 years:
Croatian: Djeca u dobi od 6 mjeseci do 5 godina:
English: NAME OF THE MEDICINAL PRODUCT Celvapan suspension for injection
Croatian: Celvapan suspenzija za injekciju
English: CELVAPAN suspension for injection Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Croatian: CELVAPAN suspenzija za injekciju cjepivo protiv influence (H1N1)v (cijeli virion, iz Vero stanica, inaktivirano)
English: Very common: Injection site redness, drowsiness, irritability, loss of appetite, crying
Croatian: Vrlo često: Crvenilo na mjestu primjene injekcije, omamljenost, razdražljivost, gubitak apetita, plačljivost
English: Clinical studies with Celvapan (H1N1)v currently provide:
Croatian: Klinička ispitivanja s Celvapanom (H1N1)v trenutno pružaju:
English: The vaccine should not be administered intravascularly.
Croatian: Cjepivo se ne smije primjenjivati intravaskularno.
English: Name and address of the manufacturers of the biological active substance(s)
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: Children aged 6 to 35 months
Croatian: Djeca u dobi od 6 do 35 mjeseci
English: * propagated in Vero cells (continuous cell line of mammalian origin) ** expressed in micrograms haemagglutinin
Croatian: * umnožen u Vero stanicama (kontinuirana stanična linija porijeklom od sisavaca) ** izraženo u mikrogramima hemaglutinina
English: Influenza vaccine (H1N1)v (whole virion, Vero cell derived, inactivated)
Croatian: Cjepivo protiv influence (H1N1)v (cijeli virion, iz Vero stanica, inaktivirano)
English: Very common: Pain and redness where the injection was given, aching muscles Uncommon: Influenza like illness
Croatian: Vrlo često: Bol i crvenilo na mjestu primjene injekcije, bol u mišićima Manje često: Bolest slična influenci
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE
English: 1st Dose
Croatian: 1. doza
English: Your doctor will discuss with you whether you should be given Celvapan.
Croatian: Liječnik će s Vama razgovarati o tome trebate li
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT
Croatian: 6. POSEBNO UPOZORENJE O ČUVANJU LIJEKA IZVAN POGLEDA
English: Do not use Celvapan after the expiry date which is stated on the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju.
English: Safety data after the first and second vaccination suggest a similar safety profile to that reported for the influenza vaccines
Croatian: Podaci o sigurnosti nakon prvog i drugog cijepljenja ukazuju na sigurnosni profil sličan onome zabilježenom kod cjepiva protiv influence koja koriste soj H5N1.
English: Whole virus influenza vaccine, inactivated containing antigen of strain*:
Croatian: Cjepivo protiv influence (cijeli virus), inaktivirano, koje sadrži antigen soja*:
English: There are no data on co-administration of Celvapan with other vaccines.
Croatian: Nema podataka o istovremenoj primjeni Celvapana s drugim cjepivima.
English: From post-marketing surveillance with egg-derived trivalent seasonal influenza vaccines, the following serious adverse reactions have been reported:
Croatian: Sljedeće ozbiljne nuspojave prijavljene su tijekom postmarketinškog praćenja trivalentnih, u jajima umnoženih cjepiva protiv sezonske gripe:
English: In a clinical study the 7.5 µg dose of Celvapan (H1N1)v was administered to adults aged 18 to 59 years (N = 101) and older people over 60 years of age (N = 101).
Croatian: U kliničkom je ispitivanju doza od 7,5 µg Celvapana (H1N1)v primijenjena na odraslima u dobi od 18 do 59 godina (N = 101) i starijim osobama u dobi iznad 60 godina (N = 101).
English: There is no information on administration of the vaccine Celvapan with other vaccines.
Croatian: Nema informacija o primjeni cjepiva Celvapan s drugim cjepivima.
English: • if you previously had a sudden life-threatening allergic reaction to any ingredient of Celvapan or to any of the substances that may be present in trace amounts as follows: formaldehyde,
Croatian: Što morate znati prije nego što primite Celvapan ako ste prethodno imali naglu i po život opasnu alergijsku reakciju na bilo koji sastojak Celvapana ili na bilo koju tvar koja može biti prisutna u tragovima kao što je: formaldehid,
English: Celvapan is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus When a person is given the vaccine, the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease.
Croatian: Kada osoba primi cjepivo, imunološki sustav (prirodni obrambeni sustav tijela) stvara vlastitu zaštitu (protutijela) protiv bolesti.
English: NERVOUS SYSTEM DISORDERS Headache Dizziness
Croatian: POREMEĆAJI ŽIVČANOG SUSTAVA
English: • you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to formaldehyde, benzonase, or to sucrose.
Croatian: • ako ste imali bilo kakvu alergijsku reakciju osim naglih po život opasnih alergijskih reakcija na bilo koji sastojak cjepiva, na formaldehid, benzonazu ili na saharozu. (za dodatne informacije
English: The immunogenicity of the vaccine containing 7.5 μg non-adjuvanted HA derived from strain A/California/07/2009 (H1N1)v has been evaluated in clinical studies in adults aged 18 years and older (N = 200), in children and adolescents aged 3 to 17 years (N = 102), and in infants and young children aged 6 to 35 months (N = 68) following a 0, 21 day schedule.
Croatian: Imunogenost cjepiva koje sadrži 7,5 μg neadjuvantiranog HA dobivenog iz soja A/California/07/2009 (H1N1)v procijenjena je u kliničkim ispitivanjima u odraslih u dobi od 18 godina naviše (N = 200), djece i adolescenata u dobi od 3 do 17 godina (N = 102) te u dojenčadi i male djece u dobi od 6 do 35 mjeseci (N = 68) u skladu s rasporedom primjene 0. i 21. dana.
English: • Side effects observed with flu vaccines given routinely every year The side effects listed below have occurred in the days or weeks after vaccination with vaccines given routinely every year to prevent flu.
Croatian: U danima ili tjednima nakon cijepljenja cjepivima koja se rutinski daju svake godine radi sprečavanja gripe pojavile su se nuspojave navedene u nastavku.
English: Children and adolescents 6 months to 17 years of age In a clinical study the frequency and type of side effects after the first and second injection were basically similar to that seen in the adult and older population using Celvapan.
Croatian: U kliničkom ispitivanju, učestalost i vrsta simptoma nakon prve i druge injekcije bili su u načelu slični onima zabilježenima u odraslih i starijih osoba koje su koristile Celvapan.
English: * MN titre ≥ 1:40 ** > 4-fold increase in MN titre *** geometric mean increase
Croatian: * MN titar ≥ 1:40 ** > četverostruko povećanje u MN titru
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not inject intravascularly.
Croatian: DRUGO POSEBNO UPOZORENJE, AKO JE POTREBNO
English: Clinical Trial Adverse Reactions H1N1v studies
Croatian: Klinička ispitivanja nuspojava H1N1v
English: In an observational safety study including 3216 subjects aged 6 months to 60 years and older, the nature of adverse events was consistent with those observed in other clinical studies in adults and children.
Croatian: • Praćenje nakon stavljanja gotovog lijeka u promet Pandemijsko opservacijsko ispitivanje s Celvapanom (H1N1)v U opservacijskom ispitivanju sigurnosti koje je uključivalo 3216 ispitanika u dobi od 6 mjeseci do 60 godina i starijih, narav štetnih događaja bila je slična onima zabilježenima kod drugih kliničkih ispitivanja u odraslih i djece.
English: • severe stabbing or throbbing pain along one or more nerves • low blood platelet count which can result in bleeding or bruising
Croatian: • jaka probadajuća ili pulsirajuća bol duž jednog ili više živaca
English: • Injection site erythema
Croatian: • Eritem na mjestu injekcije
English: 4.7 Effects on ability to drive and use machines Some undesirable effects mentioned under section 4.8 “Undesirable effects” may affect the ability to
Croatian: Neke od nuspojava spomenutih u dijelu 4.8 ”Nuspojave” mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima.
English: ** ≥ 4-fold increase in MN titre *** geometric mean increase
Croatian: ** ≥ četverostruko povećanje MN titra *** povećanje geometrijske sredine
English: Children and adolescents aged 5 to 17 years:
Croatian: Djeca i adolescenti u dobi od 5 do 17 godina:
English: Children and adolescents (3 - 17 years of age)
Croatian: Djeca i adolescenti (u dobi od 3 do 17 godina)
English: Adverse reactions from clinical trials with Celvapan (H1N1)v in a healthy adult and older people are listed in the table below.
Croatian: Nuspojave iz kliničkih ispitivanja s Celvapanom (H1N1)v u populaciji zdravih odraslih i starijoj populaciji navedene su u tablici u nastavku.
English: • neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known as Guillain-Barré Syndrome
Croatian: neuritis (upala živaca) i vrsta paralize poznata kao Guillain-Barréov sindrom
English: Pandemic Observational Study with Celvapan (H1N1)v
Croatian: Nuspojave iz Pandemijskog opservacijskog ispitivanja s CELVAPANOM (H1N1)v
English: Side effects from the Pandemic Observational Study with CELVAPAN (H1N1)v Results from a clinical study done on marketed vaccine confirmed the safety profile as observed in the clinical studies.
Croatian: Rezultati kliničkog ispitivanja provedenog na cjepivu koje se nalazi na tržištu potvrdili su sigurnosni profil zabilježen u kliničkim ispitivanjima.
English: METABOLISM AND NUTRITION DISORDERS
Croatian: POREMEĆAJI METABOLIZMA
English: Immune response against a version of Celvapan containing A/H5N1 vaccine strains The immunogenicity of the vaccine containing 7.5 µg non-adjuvanted HA derived from strain A/Vietnam/1203/2004 has been evaluated in two clinical studies in adults aged 18 - 59 years (N = 312) and in older subjects aged 60 years and older (N = 272) following a 0, 21 day schedule.
Croatian: Imunogenost cjepiva koje sadrži 7,5 µg neadjuvantiranog HA dobivenog iz soja A/Vietnam/1203/2004 procijenjeno je u dva klinička ispitivanja u odraslih u dobi od 18 do 59 godina (N = 312) te u starijih ispitanika u dobi od 60 godina naviše (N = 272) slijedeći raspored primjene 0. i 21. dana.
English: In such cases, you should be aware that the side effects may be more intense.
Croatian: U takvim slučajevima, morate znati da bi se
English: • Pain, redness, swelling or a hard lump where the injection was given, reduced movement in the Side effects from clinical studies in children
Croatian: • Bol, crvenilo, oteknuće ili tvrda kvržica na mjestu injekcije, smanjena pokretljivost ruke u koju
English: Children and adolescents 3 to 17 years of age
Croatian: Djeca i adolescenti u dobi od 3 do 17 godina
English: The following adverse reactions were reported at a higher frequency category than in the
Croatian: Sljedeće su nuspojave prijavljene s većom učestalošću nego u drugim kliničkim ispitivanjima:
English: Very Common Common
Croatian: Vrlo često Često
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by single radial hemolysis (SRH) and microneutralization assay (MN) in infants and young children aged 6 to 35 months was as follows:
Croatian: Prisutnost anti-HA protutijela 180 dana i 360 dana nakon prvog cijepljenja izmjerena jednosmjernom radijalnom hemolizom (SRH) i mikroneutralizacijskom analizom (MN) u dojenčadi i male djece u dobi od 6 do 35 mjeseci bila je sljedeća:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: What Celvapan looks like and contents of the pack Celvapan is a clear to opalescent, translucent liquid.
Croatian: Celvapan je bistra do opalescentna, prozirna tekućina.
English: The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in children aged 6 to 35 months were as follows:
Croatian: Stopa serozaštite, stopa serokonverzije i čimbenik serokonverzije za anti HA-protutijela izmjereni jednosmjernom radijalnom hemolizom (SRH) u djece u dobi od 6 do 35 mjeseci bili su sljedeći:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Whole virion influenza vaccine, inactivated containing antigen of strain *:
Croatian: Cjepivo protiv influence (cijeli virion), inaktivirano, koje sadrži antigen soja*:
English: Persistence of anti-HA antibodies 180 days after the first vaccination as measured by single radial haemolysis (SRH) and microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above was as follows:
Croatian: Prisutnost anti-HA protutijela 180 dana nakon prvog cijepljenja izmjerena jednosmjernom radijalnom hemolizom (SRH) i mikroneutralizacijskom analizom (MN) u odraslih osoba u dobi od 18 do 59 godina i starijih ispitanika u dobi od 60 godina naviše bila je sljedeća:
English: • Injection site induration
Croatian: • Induracija na mjestu injekcije
English: Adverse reactions from pediatric clinical trials with CELVAPAN (H1N1)v are listed in the table below.
Croatian: Nuspojave iz kliničkih ispitivanja s CELVAPANOM (H1N1)v na pedijatrijskoj populaciji navedene su u tablici u nastavku.
English: ** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline
Croatian: ** ili površina SRH > 25 mm² ako je polazni uzorak negativan ili povećanje SRH područja za 50%
English: Children and adolescents aged 6 months to 17 years of age:
Croatian: Djeca i adolescenti u dobi od 6 mjeseci do 17 godina
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in children and adolescents aged 3 to 17 years were as follows:
Croatian: Nakon cijepljenja stopa ispitanika čiji titri neutralizirajućih protutijela iznose ≥ 40, stopa serokonverzije i čimbenik serokonverzije izmjereni mikroneutralizacijskom analizom (MN) u djece i adolescenata u dobi od 3 do 17 godina bili su sljedeći:
English: The seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in children and adolescents aged 3 to 17 years were as
Croatian: Stopa serozaštite, serokonverzije i čimbenik serokonverzije za anti-HA protutijela izmjereni jednosmjernom radijalnom hemolizom (SRH) u djece i adolescenata u dobi od 3 do 17 godina
English: After vaccination the seroprotection rate, seroconversion rate and seroconversion factor for anti-HA antibody as measured by single radial haemolysis (SRH) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Croatian: Nakon cijepljenja stopa serozaštite, serokonverzije i čimbenik serokonverzije za anti-HA protutijela izmjereni jednosmjernom radijalnom hemolizom (SRH) u osoba u dobi od 18 do 59 godina i starijim ispitanicima u dobi od 60 godina naviše bili su sljedeći:
English: Medicinal product subject to medical prescription.
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: The side effects listed below have occurred with Celvapan (H1N1)v in adults and children during the
Croatian: Nuspojave navedene u nastavku pojavile su se nakon primjene Celvapana (H1N1)v u odraslih i djece tijekom programa cijepljenja protiv pandemijske gripe.
English: Seronegative subjects at baseline
Croatian: 16. PODACI NA BRAILLEOVOM PISMU
English: The vaccine should never be
Croatian: Cjepivo se nikad ne smije dati u krvnu žilu.
English: Very common Common
Croatian: Često Često Često
English: Antibody persistence
Croatian: Prisutnost protutijela
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in adults aged 18 to 59 years and in older subjects aged 60 years and above were as follows:
Croatian: Nakon cijepljenja stopa ispitanika čiji titri neutralizirajućih protutijela iznose ≥ 40, stopa serokonverzije i čimbenik serokonverzije izmjereni mikroneutralizacijskom analizom (MN) u osoba u dobi od 18 do 59 godina i starijih ispitanika u dobi od 60 godina naviše bili su sljedeći:
English: SRH Assay
Croatian: Baxter AG
English: * SRH area > 25 mm² ** either SRH area > 25 mm² if baseline sample negative or 50% increase in SRH area if baseline sample > 4 mm² *** geometric mean increase
Croatian: * SRH površina > 25 mm² ** ili površina SRH > 25 mm² ako je polazni uzorak negativan ili povećanje SRH područja za 50%
English: • Injection site movement impairment
Croatian: • Otežano pokretanje na mjestu injekcije
English: Seronegative subjects at baseline 21 Days After nd
Croatian: Ispitanici seronegativni na početku (< 1:10) 21 dan kasnije
English: If you get any of the side effects talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: MN Assay
Croatian: MN analiza
English: Persistence of anti-HA antibodies 180 days and 360 days after the first vaccination as measured by single radial hemolysis (SRH) and microneutralization (MN) assay in children and adolescents
Croatian: Prisutnost anti-HA protutijela 180 dana i 360 dana nakon prvog cijepljenja izmjerena jednosmjernom radijalnom hemolizom (SRH) i mikroneutralizacijskom analizom (MN) u djece i adolescenata u dobi od 3 do 17 godina bila je sljedeća:
English: After vaccination the rate of subjects with neutralizing antibody titres ≥ 40, seroconversion rate and seroconversion factor as measured by microneutralisation assay (MN) in children aged 6 to 35 months
Croatian: Nakon cijepljenja stopa ispitanika čiji titri neutralizirajućih protutijela iznose ≥ 40, stopa serokonverzije i čimbenik serokonverzije izmjereni mikroneutralizacijskom analizom (MN) u djece i adolescenata u dobi od 6 do 35 mjeseci bili su sljedeći:
English: Very common: Feeling tired, headache
Croatian: Vrlo često: Osjećaj umora, glavobolja Manje često: Kašalj