FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection 2
Croatian: Injekcija 2
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA ŠTRCALJKU
English: Name and address of the manufacturer responsible for batch release Seqirus Vaccines Ltd
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Seqirus Vaccines Ltd
English: AFLUNOV has been evaluated in healthy adults (18-60 years of age) and healthy elderly (over 60 years of age) following a 1, 22 day primary vaccination schedule, and booster vaccination (see sections 4.8 and 5.1).
Croatian: AFLUNOV je procijenjen u zdravih odraslih osoba (u dobi od 18 do 60 godina) i zdravih starijih osoba (u dobi od 60 godina naviše) uz raspored primarnog cijepljenja po principu na dan 1, pa 22 dana te booster cijepljenje (vidjeti dijelove 4.8 i 5.1).
English: One dose of 0.5 ml will be given.
Croatian: Daje se jedna doza od 0,5 ml.
English: Some degree of cross-reactive immunity has been observed against H5N1 viruses of clades different to that of the vaccine strain.
Croatian: Izvjesni stupanj križnog reaktivnog imunonosnog odgovora primjećen je protiv virusa H5N1koji pripadaju kladama različitim od klada soja iz cjepiva.
English: • Low blood platelet count which can result in bleeding or bruising.
Croatian: • Smanjen broj trombocita koji može dovesti do krvarenja ili nastanka modrica.
English: MN results yielded a GMR against A/turkey/Turkey/2005 ranging from 1.59 to 2.95.
Croatian: Rezultati MN analize pokazali su da je srednja geometrijska vrijednost (GMR) protiv virusa A/turkey/Turkey/2005 u rasponu od 1,59 do 2,95.
English: Seqirus Netherlands B.V. Paasheuvelweg 28
Croatian: Seqirus Netherlands B.V.
English: Adolescents(9-<18 years)
Croatian: Adolescenti (9-<18 godina)
English: Medical Conditions N=140
Croatian: Medicinsko stanje N=140
English: • Convulsions
Croatian: • Konvulzije
English: A single vaccination with AFLUNOV (A/Vietnam/1194/2004) induced high and rapid serological response in subjects primed 6-8 years previously with two doses of a different surrogate H5N vaccine, having same formulation as AFLUNOV but using the strain H5N3.
Croatian: Samo jedno cijepljenje cjepivom AFLUNOV (A/Vietnam/1194/2004) izazvalo je snažan i brz serološki odgovor u ispitanika koji su primarno cijepljeni prije 6-8 godina s dvije doze različitog surogata cjepiva H5N koje je imalo istu formulaciju kao AFLUNOV, ali je sadržavalo soj H5N3.
English: AFLUNOV may be co-administered with non-adjuvanted seasonal influenza vaccines, and immunisation should be carried out on separate limbs.
Croatian: Cjepivo AFLUNOV se može primijeniti istodobno s neadjuvantiranim cjepivima protiv sezonske influence a imunizacija se mora provesti na različitim udovima.
English: Immunocompromised N=143
Croatian: Imunološki kompromitirani N=143
English: No increase in reactions was reported when a booster dose was administered 6 months-18 months later, after the initial dosing series.
Croatian: Nije prijavljeno nikakvo povećanje reakcija kod primjene booster doze 6-18 mjeseci nakon početne serije cijepljenja.
English: Heterologous immune response against A/Indonesia/5/2005 (clade 2.1) was detectable in study V87P11 after the second vaccination, indicating cross-reactivity of the clade 2.2.1 vaccine against clade 2.1 strains.
Croatian: Heterologni imunološki odgovor na virus A/Indonesia/5/2005 (klada 2.1) bio je uočljiv u studiji V87P11 nakon drugog cijepljenja, upućujući na križnu reaktivnost za soj klade 2.2.1 iz cjepiva i sojeve klade 2.1.
English: PSUR submission when AFLUNOV is used during an influenza pandemic:
Croatian: Periodička izvješća o neškodljivosti lijeka (PSUR-evi) Podnošenje PSUR-eva kad se AFLUNOV koristi tijekom pandemije influence:
English: Active immunisation against H5N1 subtype of Influenza A virus.
Croatian: Aktivna imunizacija protiv podtipa H5N1 virusa influence A.
English: What you need to know before you receive AFLUNOV You should not receive AFLUNOV:
Croatian: Što morate znati prije nego primite AFLUNOV
English: Injection 3
Croatian: Injekcija 3
English: This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of the vaccine containing A/turkey/Turkey/1/2005 (H5N1)-like strain (see sections 4.4 and 5.1).
Croatian: Ova indikacija temelji se na podacima o imunogenosti u zdravih ispitanika u dobi od 18 godina naviše nakon primjene dviju doza cjepiva koje sadrži A/turkey/Turkey/1/2005 (H5N1)-sličan soj (vidjeti dio 4.4 i 5.1).
English: The following adverse events were reported from post-marketing surveillance with Focetria (an H1N1 pandemic vaccine similar to AFLUNOV) which contains the same amount of adjuvant MF59C.1 as AFLUNOV, approved for use in children 6 months of age and above, adults and the elderly:
Croatian: Sljedeći štetni događaji prijavljeni su tijekom praćenja nakon stavljanja u promet cjepiva Focetria (pandemijskog cjepiva protiv H1N1 sličnog cjepivu AFLUNOV) koji sadrži jednaku količinu adjuvanta MF59C.1 kao i cjepivo AFLUNOV, odobrenog za primjenu u djece u dobi od 6 mjeseci i starije, odraslih i starijih osoba.
English: Results are shown by SRH.
Croatian: Rezultati su prikazani SRH vrijednostima.
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms** per 0.5 ml dose
Croatian: A/turkey/Turkey/1/2005 (H5N1)-sličan soj (NIBRG-23) (klada 2.2.1) 7,5 mikrograma** po dozi od 0,5 ml
English: Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Disodium phosphate dihydrate (E339) Magnesium chloride hexahydrate (E511) Calcium chloride dihydrate (E 509) Sodium citrate (E311) Citric acid (E330)Water for injections.
Croatian: natrijev klorid kalijev klorid (E508) kalijev dihidrogenfosfat (E340) natrijev hidrogenfosfat dihidrat (E339) magnezijev klorid heksahidrat (E511) kalcijev klorid dihidrat (E509) natrijev citrat (E311) citratna kiselina (E330) voda za injekcije
English: A slight increase in reactions in adults was reported when a booster dose was administered 18 months after the initial dosing series.
Croatian: Blago povećanje reakcija u odraslih osoba prijavljeno kod primjene booster doze 18 mjeseci nakon početne serije cijepljenja.
English: How to store AFLUNOV
Croatian: Kako čuvati AFLUNOV
English: A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1) 7.5 micrograms haemagglutinin
Croatian: A/turkey/Turkey/1/2005 (H5N1)-sličan soj (NIBRG-23) (klada 2.2.1) 7,5 mikrograma hemaglutinina
English: • Urticaria (hives)
Croatian: • Urtikariju (koprivnjaču)
English: Medical conditions
Croatian: Medicinsko stanje
English: Two doses of AFLUNOV were administered three weeks apart to 156 healthy adultsImmunogenicity was assessed in 149 subjects.
Croatian: Dvije doze cjepiva AFLUNOV primijenjene su s razmakom od tri tjedna u 156 zdravih odraslih osoba.
English: Gently shake before use.
Croatian: Lagano protresti prije primjene.
English: MN results for the three clinical studies in the Table above revealed a seroprotection rate and seroconversion rate against A/turkey/Turkey/2005 ranging from 10% (2-27) to 39% (32-46) and 10% (2-27) to 36% (29-43) respectively.
Croatian: Rezultati MN analize za tri klinička ispitivanja u gornjoj tablici pokazali su stopu seroprotekcije na virus A/turkey/Turkey/2005 u rasponu od 10% (2-27) do 39% (32-46) te stopu serokonverzije od 10% (2-27) do 36% (29-43).
English: The following solicited adverse reactions were additionally collected in these two studies and reported with the following frequencies across subjects who received AFLUNOV irrespective of age or health status: diarrhoea (up to 11.9%), loss of appetite (up to 10.9%) and vomiting (up to 1.7%).
Croatian: neovisno o dobi i zdravstvenom stanju: dijarea (do 11,9%), gubitak apetita (do 10,9%) i povraćanje (do 1,7%).
English: A phase II clinical trial (V87P1) was conducted with AFLUNOV (A/Vietnam/1194/2004) in 312 healthy adults.
Croatian: Kliničko ispitivanje faze II (V87P1) provedeno je s cjepivom AFLUNOV (A/Vietnam/1194/2004 na 312 zdravih odraslih osoba.
English: Gastrointestinal disorders Gastrointestinal disorders such as nausea, vomiting, abdominal pain and diarrhoea.
Croatian: Poremećaji probavnog sustava Gastrointestinalni poremećaji poput mučnine, povraćanja, boli u abdomenu i dijaree
English: After 3 weeks from the 2nd vaccination (day 43) all age groups (i.e. 6-35 months, 3-8 years and 9-17 years) achieved high levels of antibodies to (A/Vietnam/1194/2004) as evaluated with SRH and HI assays as presented in table below.
Croatian: Tri tjedna nakon 2. cijepljenja (43. dan) sve dobne skupine (tj. 6-35 mjeseci, 3-8 godina i 9-17 godina) postigle su visoke razine protutijela na virus (A/Vietnam/1194/2004), što je procijenjeno SRH i HI analizama i prikazano u tablici u nastavku.
English: AFLUNOV injection H5N1 Zoonotic influenza vaccine IM
Croatian: AFLUNOV injekcija Cjepivo protiv zoonozne influence H5N1 i.m.
English: • Rash or swelling of the skin and mucous membranes
Croatian: • Osip ili oticanje kože i sluznica
English: Immunogenicity of AFLUNOV (A/turkey/Turkey/1/2005) in adults (18 to 60 years) and elderly (>61 years) subjects with underlying medical conditions (Study V87_25) or immunosuppressive conditions (mainly HIV-infected subjects) (Study V87_26) in comparison to healthy adults (18-60 years) and elderly (>61 years), was evaluated in two randomised, phase III controlled clinical trials (with a seasonal trivalent inactivated MF59-adjuvanted subunit influenza vaccine approved for use in elderly subjects 65 years of age and older as a comparator).
Croatian: Imunogenost cjepiva AFLUNOV (A/turkey/Turkey/1/2005) u odraslih (18-60 godina) i starijih (≥61 godina) ispitanika kod kojih postoji patološko stanje (Ispitivanje V87_25) ili stanje imunosupresije (uglavnom ispitanici s HIV-infekcijom) (Ispitivanje V87_26) u usporedbi sa zdravim odraslim osobama (18-60 godina) i osobama starije dobi (≥61 godina), procjenjivana je u dva randomizirana kontrolirana klinička ispitivanja faze III (sa sezonskim trovalentnim inaktiviranim MF59-adjuvantiranim podjediničnim cjepivom protiv influence odobrenim za primjenu u starijih ispitanika u dobi od 65 godina i starijih kao komparatora).
English: Adults (18-59 years)a
Croatian: Odrasli (18-59 godina) a
English: If administration of AFLUNOV with other vaccines can not be avoided, the vaccines should be injected into separate limbs.
Croatian: Ako se primjena cjepiva AFLUNOV s ostalim cjepivima ne može izbjeći, cjepiva treba injicirati u suprotne udove.
English: Elderly years)*
Croatian: Starije osobe godina)*
English: Data in children and adolescents suggest a slight decrease in side effects after the second dose of the vaccine, with no increase in rates of fever.
Croatian: Podaci za djecu i adolescente upućuju na nešto manji broj nuspojava nakon druge doze cjepiva,
English: Study V87_25
Croatian: Studija V87_25
English: Study V87_26
Croatian: Studija V87_26
English: Immune response to vaccination assessed by MN assay is in line with results obtained with SRH.
Croatian: Imunološki odgovor na cijepljenje procijenjen MN analizom u skladu je s rezultatima dobivenim SRH analizom.
English: “Possible side effects” may affect the ability to drive or use machines.
Croatian: Neke od nuspojava spomenutih u dijelu 4. "Moguće nuspojave" mogu utjecati na sposobnost upravljanja vozilima ili rada na strojevima.
English: Adverse reactions in special populations have been evaluated in two clinical trials, V87_25 and V87_26, involving adult (18-60 years) and elderly (≥ 61 years) subjects who were either healthy or with underlying medical conditions or immunosuppressive conditions.
Croatian: Klinička ispitivanja u posebnim populacijama bolesnika Nuspojave u posebnim populacijama procjenjivane su u dva klinička ispitivanja, V87_25 i V87_26, koja su uključivala odrasle ispitanike (18-60 godina) i ispitanike starije dobi (≥61 godine) koji su bili ili zdravi ili su imali postojeće medicinsko stanje ili stanje imunosupresije.
English: Excipient with known effect: The vaccine contains 1.899 milligrams of sodium and 0.081 milligrams of potassium per 0.5 ml dose.
Croatian: Cjepivo sadrži 1,899 miligrama natrija i 0,081 miligrama kalija po dozi od 0,5 ml.
English: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Croatian: Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja:
English: AFLUNOV is a suspension for injection in a pre-filled syringe.
Croatian: AFLUNOV je suspenzija za injekciju u napunjenoj štrcaljki.
English: • Aching muscles
Croatian: • Bol u mišićima
English: In a phase I clinical trial (V87P3) adult subjects aged 18-65 years primed 6-8 years previously with 2 doses of MF59-adjuvanted H5N3 vaccine/A/Duck/Singapore/97, were administered 2 booster doses of AFLUNOV (A/Vietnam/1194/2004).
Croatian: U kliničkom ispitivanju faze I (V87P3) odrasli ispitanici u dobi od 18 do 65 godina koji su primarno cijepljeni pred 6-8 godina s 2 doze MF59-adjuvantiranog cjepiva H5N3/A/Duck/Singapore/97, primili su 2 booster doze cjepiva AFLUNOV (A/Vietnam/1194/2004).
English: If you have any further questions on the use of this medicinal product, ask your doctor or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili medicinskoj sestri.
English: Immune response to vaccination assessed by MN assay is similar to SRH results.
Croatian: Imunološki odgovor na cijepljenje procijenjen MN analizom sličan je rezultatima SRH analize.
English: General disorders and administration site conditions Extensive swelling of injected limb lasting more than one week, injection-site cellulitis-like reaction (some cases of swelling, pain, and redness extending more than 10 cm and lasting more than 1 week).
Croatian: Prekomjerno oteknuće ekstremiteta u koji je ubrizgano cjepivo, a koje traje duže od jednog tjedna, reakcija nalik celulitisu na mjestu injekcije (nekoliko slučajeva oteknuća, bola i crvenila na mjestu injekcije, veličine preko 10 cm i s trajanjem dužim od jednog tjedna) Pedijatrijska populacija
English: In a clinical trial evaluating 4 different vaccination schedules in 240 subjects 18 to 60 years of age, where the second dose occurred either 1, 2, 3 or 6 weeks after the first AFLUNOV
Croatian: U kliničkom ispitivanju kojim su se procjenjivala 4 različita rasporeda cijepljenja na 240 ispitanika u dobi od 18 do 60 godina, gdje je druga doza primijenjena 1, 2, 3 ili 6 tjedana nakon prve doze cjepiva AFLUNOV (A/Vietnam/1194/2004).
English: MedDRA System Organ class Very common
Croatian: MedDRA klasifikacija organskih sustava
English: Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted).
Croatian: Cjepivo protiv zoonozne influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano).
English: Zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Croatian: Cjepivo protiv zoonozne influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano)
English: Immune response to AFLUNOV A/Vietnam/1194/2004 (H5N1) and A/turkey/Turkey/1/2005 (H5NI)
Croatian: Imunološki odgovor na cjepivo AFLUNOV A/Vietnam/1194/2004 (H5N1) i A/turkey/Turkey/1/2005 (H5N1)
English: Lung damage was reduced in vaccinated groups.
Croatian: U cijepljenim je skupinama smanjeno oštećenje pluća.
English: Milky-white liquid.
Croatian: Mliječnobijela tekućina.
English: In a third clinical trial (V87P11) 194 adult subjects were enrolled and received two doses of AFLUNOV (A/turkey/Turkey/1/2005) administered three weeks apart.
Croatian: U treće kliničko ispitivanje (V87P11) uključene su 194 odrasle osobe koje su primile dvije doze cjepiva AFLUNOV (A/turkey/Turkey/1/2005) u razmaku od tri tjedna.
English: MN results against homologous A/turkey/Turkey/1/2005 indicate a seroconversion rate of 66.67% in healthy adults, and ranging from 33.57% to 54.14% in adults with immunosuppressive or underlying medical conditions, respectively; seroconversion rates ranged from 24.39% to 29.03% in healthy elderly subjects, and from 31.65% to 39.42% in elderly subjects with immunosuppressive or underlying medical conditions.
Croatian: Rezultati za MN protiv homolognog virusa podtipa A/turkey/Turkey/1/2005 ukazuju na stopu serokonverzije od 66,67% u zdravih odraslih, i kreće se od 33,57% do 54,14% u odraslih s imunosupresijom odnosno postojećim medicinskim stanjem; stope serokonverzije kretale su se od 24,39% do 29,03% u zdravih starijih ispitanika i od 31,65% do 39,42% u starijih ispitanika s imunosupresijom ili postojećim medicinskim stanjem.
English: Toddlers (6-<36 months)
Croatian: Mala djeca (6-<36 mjeseci)
English: Common (≥1/100 to <1/10)
Croatian: Često (≥1/100 i
English: There are no data on co-administration of AFLUNOV with vaccines other than non-adjuvanted seasonal influenza vaccines.
Croatian: Nema podataka o istodobnoj primjeni cjepiva AFLUNOV s drugim cjepivima osim neadjuvantiranih sezonskih cjepiva protiv influence.
English: To be administered intramuscularly into the deltoid muscle.
Croatian: Primjenjuje se intramuskularno u deltoidni mišić.
English: These side effects may occur with AFLUNOV.
Croatian: Te se nuspojave mogu pojaviti s cjepivom AFLUNOV.
English: In addition, duration a pandemic, resources needed for an in-depth evaluation of PSURs 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: tijekom pandemije, resursi potrebni za dubinsku procjenu PSUR-eva u formatu definiranom u Svesku 9a Pravilnika koji uređuje lijekove u Europskoj
English: Rare (affects 1 to 10 users in 10.000):
Croatian: Rijetko (javlja se u 1 do 10 na 10 000 korisnika):
English: - Active Substance: Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
Croatian: Djelatna tvar: Površinski antigeni virusa influence (hemaglutinin i neuraminidaza)* soja:
English: • Sweating
Croatian: • Drhtanje • Znojenje
English: MN results against a A/Vietnam/1194/2004 indicate a seroprotection rate of 99% (95%CI: 94-100), a seroconversion rate ranging from 97% (95%CI: 91-99) to 99% (95%CI: 96-100) and a GMR ranging from 29 (95%CI: 25-35) to 50 (95%CI: 44-58).
Croatian: Rezultati MN analiza na virus A/Vietnam/1194/2004 upućuju na stopu seroprotekcije od 99% (95%CI: 94-100), stopu serokonverzije u rasponu od 97% (95%CI: 91-99) do 99% (95%CI: 96-100) i omjer srednje geometrijske vrijednosti (GMR) u rasponu od 29 (95%CI: 25-35) do 50 (95%CI: 44-58).
English: Blood and lymphatic system disorders Lymphadenopathy.
Croatian: Poremećaji krvi i limfnog sustava
English: Method of administration Immunisation should be carried out by intramuscular injection into the deltoid muscle.
Croatian: Imunizacija se provodi intramuskularnom injekcijom u deltoidni mišić.
English: In this trial no vaccine related SAEs were observed.
Croatian: U ovom ispitivanju nisu zabilježeni ozbiljni štetni događaji povezani s cjepivom.
English: Caution is needed when administrating this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1 and to residues (eggs and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide).
Croatian: Potreban je oprez pri primjeni cjepiva u osoba s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju od pomoćnih tvari navedenih u dijelu 6.1 i na tvari u tragovima (jaja i pileće proteine, ovalbumin, kanamicin, neomicinsulfat, formaldehid i cetiltrimetilamonijev bromid).
English: AFLUNOV(A/Vietnam/1194/2004) and an AFLUNOV-like H5N1 vaccine (A/turkey/Turkey/1/2005-like) were tested.
Croatian: Testirano je AFLUNOV (A/Vietnam/1194/2004) i H5N1-slično cjepivo AFLUNOV (A/turkey/Turkey/1/2005-sličan soj).
English: Periodic Safety Update Reports (PSURs)
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama
English: In phase III clinical trial (V87P13) 2693 adult subjects were enrolled and 2566 received two doses of AFLUNOV (A/Vietnam/1194/2004) administered three weeks apart.
Croatian: U kliničko ispitivanju faze III (V87P13) uključene su 2693 odrasle osobe od kojih je 2566 primilo dvije doze cjepiva AFLUNOV (A/Vietnam/1194/2004) primijenjene u razmaku od tri tjedna.
English: • Brusing of the skin at the injection site
Croatian: • Otvrdnuće kože na mjestu injekcije
English: Adults (19- 60 years)a
Croatian: Odrasli (19-60 godina) a
English: In Study V87P11 MN results against homologous A/turkey/Turkey/1/2005) indicate a seroprotection and seroconversion rate of 85% (79-90) and 93% (89-96), respectively.
Croatian: Rezultati MN analize u Studiji V87P11 na homologni virus A/turkey/Turkey/1/2005 upućuju na stopu seroprotekcije i serokonverzije od 85% (79-90), odnosno 93% (89-96).
English: Very common (affects more than 1 user in 10):
Croatian: Vrlo često (javlja se u više od 1 na 10 korisnika):
English: Elderly (>61 years)
Croatian: Starije osobe (≥61 godina)
English: Common (affects 1 to 10 users in 100):
Croatian: Često (javlja se u 1 do 10 na 100 korisnika):
English: Vaccination protected animals from lethal challenge even when HI antibody titres were low or undetectable.
Croatian: Cijepljenje je zaštitilo životinje od letalnog ishoda čak i kad su titri protutijela
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to egg and chicken protein, ovalbumin, formaldehyde, kanamycin and neomycin sulphate (antibiotics) or cetyltrimethylammonium bromide (CTAB) (see section 6.
Croatian: • ako ste imali bilo koju alergijsku reakciju osim nagle, po život opasne alergijske reakcije na bilo koji sastojak cjepiva, na jaja i pileće bjelančevine, ovalbumin, formaldehid, kanamicin i neomicinsulfat (antibiotici) ili cetiltrimetilamonijev bromid (CTAB) (pogledajte dio 6. za dodatne informacije);
English: Medical Conditions N=143
Croatian: Medicinsko stanje N=143
English: MN results for A/Vietnam/1194/2004 revealed a seroprotection rate of 10% (6-16) in adults (18-60 years) and 6% (3-11) in elderly (>61 years); a seroconversion rate of 19% (13-25) in adults and 7% (4-13) in elderly and finally a GMR of 1.86 (1.63-2.12) in adults and 1.33 (1.17-1.51) in elderly.
Croatian: Rezultati MN analize za virus A/Vietnam/1194/2004 pokazali su stopu seroprotekcije od 10% (6-16) u odraslih osoba (18-60 godina) i 6% (3-11) u starijih osoba (≥61 godina): stopu serokonverzije od 19% (13-25) u odraslih osoba i 7% (4-13) u starijih osoba te omjer srednje geometrijske vrijednosti (GMR) od 1,86 (1,63-2,12) u odraslih osoba i 1,33 (1,17-1,51) u starijih osoba.
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač: Nositelj odobrenja za stavljanje lijeka u promet
English: Cross-reactive immune response elicited by A/turkey/Turkey/1/2005 against A/Indonesia/5/2005 and A/Vietnam/1194/2004
Croatian: Križno reaktivan imunološki odgovor izazvan virusom A/turkey/Turkey/1/2005 na viruse A/Indonesia/5/2005 i A/Vietnam/1194/2004
English: HI Seroprotection rate (95%CI)°
Croatian: HI Stopa seroprotekcije (95%CI)°
English: ** Seroconversion was defined as an SRH area ≥25 mm2 for subjects who were seronegative at baseline (Day 1 SRH area ≤4 mm2) or a significant (at least 50%) increase in SRH area for subjects who were seropositive at baseline (Day 1 SRH area >4 mm2) *** geometric mean ratios (GMRs) of SRH
Croatian: ** Serokonverzija je definirana kao SRH površina ≥25 mm2 u ispitanika koji su bili seronegativni na početku ispitivanja (SRH površina 1. dana ≤4 mm2) ili značajni (najmanje 50%-tni) porast SRH površine za ispitnike koji su bili seropozitivni na početku ispitivanja (površina SRH 1. dana >4 mm2) *** GMR vrijednosti SRH ° izmjereno HI analizom ≥40 °° GMR vrijednosti HI-a
English: In children and adolescents, pain was the most frequently reported solicited local reaction, and fatigue and headache were the most commonly reported solicited systemic reactions.
Croatian: dok su umor i glavobolja bili najčešće prijavljene izazvane sistemske reakcije.