FrancophonIA/ELRC3.0 huggingface dataset:
English: In a second study, sixty-six ferrets were divided into 6 cohorts of 11 ferrets and were immunized on days 0 and 21 with 3.75 µg or 7.5 µg of the Indonesia vaccine or were sham vaccinated.
Croatian: U drugom je ispitivanju šezdeset šest tvorova bilo podijeljeno u 6 kohorta po 11 tvorova koji su bili imunizirani 0. i 21. dana s 3,75 µg ili 7,5 µg cjepiva Indonesia ili su bili lažno cijepljeni.
English: Frequency 6 - 35 months 3 - 8 years
Croatian: 6 - 35 mjeseci 3 - 8 godina 9 - 17 godina
English: Adverse Events of Special Interest stratified according to type of report (medically confirmed or non-medically confirmed).
Croatian: Nuspojave od posebnog interesa raslojene prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno).
English: • pain in joint or muscle
Croatian: • bol u zglobovima ili mišićima
English: Influenza-like illness
Croatian: • bolest slična gripi
English: It should be noted that the adverse reactions may be intensified.
Croatian: Potrebno je napomenuti da može doći do pojačanja nuspojava.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may make you feel dizzy or sick which may affect your ability to drive or use machines.
Croatian: Nakon primanja CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER možete osjećati omaglicu ili mučninu, što može utjecati na Vašu sposobnost upravljanja vozilima ili rada sa strojevima.
English: Clinical trials were conducted with this H5N1 vaccine (see section 5.1 for more information on the H5N1 vaccines) in approximately 3500 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 ovog cjepiva protiv virusa H5N1 (vidjeti dio 5.1. za dodatne informacije o cjepivima protiv virusa H5N1) provedena su na približno 3500 ispitanika (u dobnim skupinama od 18 do 59 godina te 60 godina i više) i posebnim rizičnim skupinama od približno 300 ispitanika koje su se sastojale od imunokompromitiranih ispitanika i pacijenata s kroničnim bolestima.
English: Similarly, the A/lndonesia/05/2005 vaccine was efficacious against a heterologous challenge, showing a vaccine dose-dependent survivorship in the vaccinated cohorts as compared to the control cohort.
Croatian: Slično tome, cjepivo A/lndonesia/05/2005 bilo je učinkovito protiv heterolognog izazova, pri čemu je zabilježeno preživljavanje ovisno o dozi cjepiva u cijepljenih skupina u usporedbi s kontrolnom skupinom.
English: The vaccine is an off-white, opalescent, translucent suspension.
Croatian: Cjepivo je gotovo bijela, opalescentna, prozirna suspenzija.
English: Heterologous Booster Vaccinations
Croatian: Heterologna booster cijepljenja
English: Preferred MedDRA Term
Croatian: Preporučeni MedDRA izraz
English: Very rare: vasculitis with transient renal involvement.
Croatian: Vrlo rijetko: vaskulitis s prolaznim zahvaćanjem bubrega.
English: • if you have had any allergic reaction, to any ingredient contained in the vaccine (see section 6 at the end of the leaflet) or to formaldehyde, benzonase or sucrose.
Croatian: • ako ste imali bilo kakvu alergijsku reakciju na bilo koji sastojak cjepiva (vidjeti dio 6 na kraju uputa) ili na formaldehid, benzonazu ili saharozu.
English: narrow SMQ “Convulsions”
Croatian: suženi SMQ “Konvulzije”
English: - Convulsion:
Croatian: - Konvulzije:
English: • Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, 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 (različitima od anafilaktičke reakcije) na djelatnu tvar, na bilo koju od pomoćnih tvari i na ostatne tvari u tragovima npr. formaldehid, benzonazu ili saharozu.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Animal reproductive and developmental toxicity 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 female fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).
Croatian: H5N1 (A/Vietnam/1203/2004 i A/Indonesia/05/2005) ne upućuju na izravne ili neizravne štetne učinke na plodnost ženki, trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj (vidjeti dio 5.3.).
English: Like all medicines, PANDEMIC INFLUENZA VACCINE H5N1 BAXTER can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: Month 12-15 Month 24
Croatian: 6 mjeseci kasnije 12 - 15 mjeseci kasnije 24 mjeseca kasnije
English: • irritation or itching at the injection site, bruising or stiff arm
Croatian: • iritacija ili svrbež na mjestu injiciranja, stvaranje modrica ili ukočena ruka
English: After shaking, the vaccine is an off-white, opalescent, translucent suspension.
Croatian: Nakon što ga protresete, cjepivo je gotovo bijela, opalescentna, prozirna suspenzija.
English: Trometamol, sodium chloride, water for injections, polysorbate 80
Croatian: Trometamol, natrijev klorid, voda za injekcije, polisorbat 80
English: Baxter AG Uferstrasse 15
Croatian: Uferstrasse 15
English: • sudden hearing loss, ear pain
Croatian: • iznenadan gubitak sluha, bol u uhu
English: Seroneutralisation rate* * MN titre ≥ 20
Croatian: Stopa seroneutralizacije* * MN titar ≥ 20
English: Cross-reactive immune response against related H5N1 strains In a phase 3 study in adults (N=270) and older subjects (N=272) 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 povezane H5N1 sojeve U fazi 3 ispitivanja u odraslih (N=270) i u starijih ispitanika (N=272) nakon cijepljenja cjepivom soja A/Vietnam/1203/2004 stopa ispitanika s križno neutralizirajućim protutijelima izmjerenima MN analizom (titar ≥ 20) bila je kako slijedi:
English: Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Croatian: PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER Molimo obavijestite svog liječnika ako uzimate ili ste nedavno uzimali bilo koji drugi lijek, uključujući lijekove dobivene bez recepta, ili ako ste nedavno primili bilo koje drugo cjepivo.
English: Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000)
Croatian: Rijetko (≥1/10 000 i <1/1 000) Vrlo rijetko (<1/10 000)
English: 12 - 24 months booster * MN titre ≥ 20
Croatian: 12 do 24-mjesečni booster * MN titar ≥ 20
English: History of an anaphylactic (i.e. life-threatening) reaction to the active substance, to any of the excipients listed in section 6.1 or to trace residues (e.g. formaldehyde, benzonase, sucrose) of this vaccine.
Croatian: Podatak o anafilaktičkoj (tj. po život opasnoj) reakciji na djelatnu tvar, na bilo koju od pomoćnih tvari navedenih u dijelu 6.1. ili na ostatne tvari u tragovima (npr. formaldehid, benzonazu, saharozu) ovog cjepiva.
English: - Vaccination failure:
Croatian: - Neuspjeh cijepljenja:
English: In the clinical studies conducted in adults and older people with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER, most side effects were mild in nature and short term.
Croatian: U kliničkim ispitivanjima s CJEPIVOM PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER na odraslim osobama i starijoj populaciji većina nuspojava bila je blage naravi i kratkotrajna.
English: One single dose pre-filled syringe (containing 0.5ml suspension)
Croatian: Jedna jednodozna napunjena štrcaljka (sadrži 0,5 ml suspenzije)
English: Skin and subcutaneous tissue disorders: angioedema Musculoskeletal and connective tissue disorders: pain in extremity Trivalent seasonal influenza vaccines
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva: bol u udovima Trovalentna cjepiva protiv sezonske gripe
English: The following side effects have been reported in clinical studies in adolescents aged 9 to 17 years.
Croatian: Sljedeće su nuspojave zabilježene u kliničkim ispitivanjima u adolescenata u dobi od 9 do 17 godina.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Multidose vial (10 doses of 0.5 ml per vial)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA Višedozna bočica (10 doza od 0,5 ml po bočici)
English: Not known (cannot be estimated from the available data)
Croatian: Nepoznato (ne može se procijeniti iz dostupnih podataka) Odrasli i starije osobe:
English: * SRH area ≥ 25 mm² ** MN titre ≥ 20
Croatian: * SRH površina ≥ 25 mm² ** MN titar ≥ 20
English: Adverse reactions are listed according to the following frequency below.
Croatian: Nuspojave su navedene prema sljedećoj učestalosti.
English: BLOOD AND LYMPHATIC SYSTEM DISORDERS
Croatian: POREMEĆAJI KRVI I LIMFNOG
English: The following side effects have been reported in clinical studies in children aged 3 to 8 years.
Croatian: Sljedeće su nuspojave zabilježene u kliničkim ispitivanjima u djece u dobi od 3 do 8 godina.
English: Dublin 2
Croatian: Dablin 2
English: narrow SMQ “Vasculitis”
Croatian: suženi SMQ “Vaskulitis”
English: Manufacturer: Baxter AG Uferstrasse 15
Croatian: Proizvođač: Baxter AG
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Baxter AG
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) with or 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) s iglama ili bez njih.
English: The safety of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in pregnancy and lactation has not been assessed in clinical trials.
Croatian: Sigurnost CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER tijekom trudnoće i dojenja nije ispitana kliničkim ispitivanjima.
English: How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER Ovaj lijek čuvajte izvan pogleda i dohvata djece.
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: Djeca i adolescenti u dobi od 3 do 17 godina: 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: The vaccine is available or as 1 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) with or without needles.
Croatian: Cjepivo je dostupno kao 1 pakiranje 1 jednodozne napunjene štrcaljke (staklo tipa I) koja sadrži 0,5 ml suspenzije za injekciju s čepom klipa bez lateksa (halogenobutilna guma) s iglama ili bez njih.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals aged 6 months and older.
Croatian: PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER cjepivo je koje se koristi u osoba starih 6 mjeseci i više.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not inject intravascularly.
Croatian: DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO
English: Injection Site Reactions
Croatian: REAKCIJE NA MJESTU PRIMJENE
English: • Immunoglobulin is not to be given with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
Croatian: • Imunoglobulin se ne daje zajedno s CJEPIVOM PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER.
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 OD 10 DOZA
English: The vaccine is available as 1 pack containing 20 multidose vials (type I glass) of 5 ml suspension (10 doses).
Croatian: Cjepivo je dostupno kao 1 pakiranje koje sadrži 20 višedoznih bočica (staklo tipa I) s 5 ml suspenzije
English: MARKETING AUTHORISATION NUMBER EU/1/09/571/002
Croatian: EU/1/09/571/002
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)
English: Infants, children, and adolescents Immune response against A/Vietnam/1203/2004 (H5N1)
Croatian: Imunološki odgovor na A/Vietnam/1203/2004 (H5N1)
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svome liječniku ili ljekarniku.
English: No case of overdose has been reported.
Croatian: 4.9 Predoziranje Nisu prijavljeni slučajevi predoziranja.
English: ** ≥ 4-fold increase in MN titer *** geometric mean increase
Croatian: ** ≥ 4-struko povećanje MN titra *** geometrijska sredina povećanja
English: The following side effects have been reported in a clinical study in infants aged 6 to 35 months.
Croatian: Sljedeće su nuspojave zabilježene u kliničkim ispitivanjima u dojenčadi u dobi od 6 do 35 mjeseci.
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) i u dojenčadi i djece u dobi od 6 do 35 mjeseci (N=33) nakon rasporeda primjene 0. i 21. dana.
English: A minor infection such as a cold should not be a problem, but your doctor should advise whether you could still be vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
Croatian: Manja infekcija kao što je prehlada ne bi trebala biti problem, no liječnik će Vam savjetovati možete li primiti CJEPIVO
English: The A/lndonesia/05/2005 vaccine was shown to be efficacious with 100% survival, reduced incidence of fever, reduced weight loss, reduced virus burden, and reduced haematological (leukopenia and lymphopenia) changes in the vaccinated cohorts following homologous challenge.
Croatian: pokazalo se učinkovitim uz 100%-tno preživljavanje, smanjene incidencije vrućice, smanjenje gubitka težine, smanjenog virusnog opterećenja i smanjenih hematoloških (leukopenija i limfopenija) promjena u cijepljenim skupinama nakon homolognog izazova.
English: Very Common Very Common
Croatian: Vrlo često Vrlo često
English: The immunogenicity of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in older subjects aged 60 years and older (N=391) following a 0, 21 day schedule.
Croatian: Imunogenost CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER (soj A/Vietnam/1203/2004) procijenjena je u tri klinička ispitivanja u odraslih u dobi od 18 do 59 godina (N=961) te u starijih ispitanika u dobi od 60 godina i više (N=391) nakon režima primjene 0. i 21. dana.
English: The A/Vietnam/1203/2004 vaccine afforded protection against homologous challenge as evidenced by full survivorship, 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: o čemu svjedoči potpuno preživljavanje, smanjen gubitak težine, manje naglašeno i kraće povećanje temperature, manje primjetno smanjenje broja limfocita te smanjenje upale i nekroze mozga i olfaktornog bulbusa u cijepljenoj skupini u usporedbi s kontrolnim životinjama.
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 OD 10 DOZA
English: An overview for all spontaneous cases per country, stratified according to type of report (medically confirmed or non-medically confirmed) and seriousness, for the period covered by the report and cumulatively.
Croatian: Pregled svih spontanih slučajeva po državi, raslojenih prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno) i ozbiljnosti, za razdoblje obuhvaćeno izvješćem i kumulativno.
English: • malaise (generally feeling unwell)
Croatian: • slabost (općento loše osjećanje)
English: Intramuscular use.
Croatian: prozirna tekućina.
English: Tested against
Croatian: Ispitano na
English: MARKETING AUTHORISATION NUMBER EU/1/09/571/001
Croatian: EU/1/09/571/001
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 titrom neutralizirajućih protutijela ≥ 20, stopa serokonverzije i čimbenik serokonverzije izmjereni MN analizom u imunokompromitiranih ispitanika i u pacijenata s kroničnim bolestima bili su sljedeći:
English: How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Contents of the pack and other information
Croatian: Kako čuvati CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER Sadržaj pakiranja i druge informacije
English: Seroneutralisation rate**
Croatian: Stopa seroneutralizacije**
English: The ferrets were challenged intranasally on day 35 with a high dose of either the clade 2 H5N1 virus A/Indonesia/05/2005 or the clade 1 H5N1 virus A/Vietnam/1203/2004 and monitored for 14 days.
Croatian: dana tvorovima su intranazalno aplicirane visoke doze skupine virusa 2 H5N1 A/Indonesia/05/2005 ili skupine virusa 1 H5N1 A/Vietnam/1203/2004 te su praćeni 14 dana.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under “exceptional circumstances”.
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER odobreno je u “iznimnim okolnostima”.
English: Antibody persistence after vaccination with the 7.5 µg non-adjuvanted formulation of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in a clinical study in adults aged 18 - 59 years and subjects aged 60 years and above at 6 months, 12 - 15 months and 24 months after the start of the primary vaccination series.
Croatian: Perzistencija protutijela nakon cijepljenja sa 7,5 µg neadjuvantirane formulacije CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER (soj A/Vietnam/1203/2004) procijenjena je u kliničkom ispitivanju u odraslih u dobi od 18 do 59 godina i ispitanika u dobi od 60 godina i više i to 6 mjeseci, 12 - 15 mjeseci i 24 mjeseca nakon početka prve serije cijepljenja.
English: Immune system disorders: anaphylactic reaction, hypersensitivity
Croatian: Poremećaji imunološkog sustava: anafilaktička reakcija, preosjetljivost Poremećaji živčanog sustava: konvulzije
English: There is no information on the use of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER under the skin.
Croatian: Ne postoje podaci o uporabi CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER pod kožu.
English: You should tell your doctor before vaccination
Croatian: Što morate znati prije nego što primite CJEPIVO
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER has been authorised under ‘exceptional circumstances'.
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER odobreno je u ‘iznimnim okolnostima'.
English: - Encephalitis:
Croatian: - Encefalitis:
English: Children and adolescents aged 3 to 17 years:
Croatian: Dojenčad i djeca u dobi od 6 do 35 mjeseci:
English: For PANDEMIC INFLUENZA VACCINE H5N1 BAXTER post-marketing surveillance data are not yet available.
Croatian: Postmarketinški podaci za CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER još nisu dostupni.
English: Seroneutralization rate*
Croatian: Stopa seroneutralizacije*
English: Injections of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER and immunoglobulin should be made into separate limbs.
Croatian: Injekcije CJEPIVA PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER i imunoglobulina potrebno je dati u različite udove.
English: • hardness, redness, swelling or minor bleeding at the injection site
Croatian: • otvrdnuće, crvenilo, oticanje ili manje krvarenje na mjestu injiciranja
English: • A protective response may not be induced in all vaccinees (see section 5.1).
Croatian: • Zaštitni odgovor možda neće biti potaknut u svih cijepljenih osoba (vidjeti dio 5.1.). 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija
English: Seroneutralisation rate* Seroconversion rate** Seroconversion factor*** * MN titre ≥ 20 ** ≥ 4-fold increase in MN titre *** geometric mean increase
Croatian: Stopa seroneutralizacije* Stopa serokonverzije** Čimbenik serokonverzije*** * MN titar ≥ 20 ** ≥ 4-struko povećanje MN titra *** geometrijska sredina povećanja
English: MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Croatian: MIŠIĆNO-KOŠTANOG SUSTAVA I VEZIVNOG TKIVA
English: Infants and children aged 6 to 35 months: In a clinical trial the H5N1 vaccine was administered to 36 infants and children aged 6 to 35 months.
Croatian: U kliničkom ispitivanju cjepivo H5N1 primilo je 36 dojenčadi i djece u dobi od 6 do 35 mjeseci.
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: The side-effects are generally similar to those related to the influenza vaccine.
Croatian: Nuspojave su u pravilu slične nuspojavama nakon primjene drugih cjepiva protiv influence.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection.
Croatian: Djelatna tvar i ostali sastojci CJEPIVA PROTIV
English: In the event of either being observed, discard the vaccine.
Croatian: Ako uočite bilo što od navedenog, odložite cjepivo u otpad.
English: • Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.
Croatian: • Kod bolesnika s endogenom ili jatrogenom imunosupresijom, stvaranje antitijela kao odgovora na cjepivo može biti nedostatno.
English: PANDEMIC INFLUENZA VACCINE H5N1 BAXTER suspension for injection Pandemic influenza vaccine (H5N1) (whole virion, inactivated, prepared in cell culture)
Croatian: CJEPIVO PROTIV PANDEMIJSKE INFLUENCE H5N1 BAXTER suspenzija za injekciju Cjepivo protiv pandemijske influence (H5N1) (cijeli virion, inaktivirano, pripremljeno u staničnoj kulturi)
English: After primary 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 prvog cijepljenja, stopa serozaštite, serokonverzije i čimbenik serokonverzije za anti-HA antitijela izmjereni jednosmjernom radijalnom hemolizom (engl. single radial haemolysis, SRH) u osoba u dobi od 18 do 59 godina i u starijih ispitanika u dobi od 60 godina i više bili su sljedeći:
English: • eye irritation
Croatian: • nadraženost oka
English: • vertigo (a spinning sensation)
Croatian: • vrtoglavica (osjećaj vrtnje)