natgillin/translations-raw huggingface dataset:
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4). 
Ovaj lijek sadrži tiomersal (organski spoj žive) kao konzervans pa je moguća reakcija senzibilizacije
Common (>1/100, <1/10): headache 
Često (>1/100 i <1/10): glavobolja
Adverse reactions from clinical trial in adults and elderly (above 18 years old) 
Sažetak profila sigurnosti Odrasli i starije osobe (u dobi iznad 18 godina)
Record date and time of the first dose withdrawal on the vial label. 
Na naljepnicu bočice treba zabilježiti datum i vrijeme izvlačenja prve doze.
Neurological disorders, such as neuralgia, paraesthesia, convulsions and neuritis. 
Neurološki poremećaji poput neuralgije, parestezije,
In another clinical trial (Phase III) (Study V87P13), 2693 healthy adults were enrolled and received two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) administered three weeks apart. 
U drugo kliničko ispitivanje (Faza III) (Studija V87P13) uključene su 2693 zdrave odrasle osobe koje su primile dvije doze cjepiva koje sadrži virus H5N1 (A/Vietnam/1194/2004; 7,5 µg HA/doza adjuvantirano) primijenjene u razmaku od tri tjedna.
Package leaflet: Information for the user Foclivia suspension for injection 
Uputa o lijeku: Informacije za korisnika Foclivia suspenzija za injekciju
Muscoskeletal, connective tissue and bone disorders Common (>1/100, <1/10): arthralgia and myalgia 
Poremećaji mišićno-koštanog sustava, vezivnog tkiva i kostiju Često (>1/100 i <1/10): artralgija i mijalgija
Once the needle is locked in place, remove the needle protector and administer the vaccine 
Nakon što je igla čvrsto pričvršćena na svoje mjesto, skinite štitnik s igle i primijenite cjepivo.
Two doses of vaccine with H5N3 (A/Duck/Singapore/97) strain at 3 different dosages (7.5, 15 and 30 µg HA/dose) were administered three weeks apart. 
Dvije doze cjepiva s virusom soja H5N3 (A/Duck/Singapore/97) u 3 različita doziranja (7,5, 15 i 30 µg HA/doza) primijenjene su u razmaku od tri tjedna.
Adverse reactions in the week following vaccination with Focetria H1N1v from 73 infants 6-11 months old and 73 toddlers 12-35 months old, receiving the 7.5 µg formulation were reported as follows: 
U tjednu nakon cijepljenja cjepivom Focetria H1N1v za 73 dojenčadi u dobi od 6 do 11 mjeseci i 73 male djece u dobi od 12 do 35 mjeseci koji su primili pripravak od 7,5 µg prijavljene su sljedeće nuspojave:
Study V87P1 Adults Booster (6 months after 2nd dose 
Studija V87P1 odrasli booster (6 mjeseci nakon 2. doze)
Adverse reactions in the week following vaccination with Focetria H1N1v from 77 children 3-8 years old and 80 children and adolescents 9-17 years old receiving the 7.5 µg formulation were reported as follows: 
U tjednu nakon cijepljenja cjepivom Focetria H1N1v za 77 djece u dobi od 3 do 8 godina i 80 djece i adolescenata u dobi od 9 do 17 godina koji su primili pripravak od 7,5 µg prijavljene su sljedeće nuspojave:
Adverse reactions from clinical trials with the pandemic preparedness vaccine Foclivia are listed below. 
Nuspojave iz kliničkih ispitivanja s cjepivom spremnim protiv pandemijske influence Foclivia navedene su u nastavku.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR SYRINGE AND 1-DOSE VIAL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA ŠTRCALJKU I 1-DOZNU BOČICU
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. 
Pregled svih spontanih slučajeva po državi, razvrstanih prema vrsti izvješća (medicinski potvrđeno ili medicinski nepotvrđeno) i ozbiljnosti, za razdoblje obuhvaćeno izvješćem i skupno.
How to store Foclivia 
Kako čuvati FOCLIVIJU
Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event 
Vrućica ≥38°C (≥40°C)
Persistence of antibodies after primary vaccination in this population was assessed by Hemagglutination Inhibition (HI), SRH, and MN assays. 
Postojanost protutijela nakon prvog cijepljenja u ovoj populaciji procijenjena je testom inhibicije hemaglutinacije (HI) te SRH i MN testovima.
7.5 micrograms haemagglutinin 
7,5 mikrograma hemaglutinina
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine 
Također možete prijaviti izravno putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V.
What you need to know before you receive Foclivia Foclivia should not be given if you: 
Focliviju se ne smije primiti ako ste:
Safety data are available, however, in pregnant women exposed to Focetria (an H1N1 pandemic vaccine similar to Foclivia) which contains the same amount of MF59C.1 as Foclivia. 
Sigurnosni podaci dostupni su, međutim, za trudnice cijepljenje cjepivom Focetria (H1N1 pandemijsko cjepivo slično cjepivu Foclivia) koje sadrži istu količinu adjuvansa MF59C.1 kao Foclivia.
The seroprotection rate and seroconversion rate measured by HI assay and the seroconversion factor expressed as geometric mean ratio of HI for anti-HA antibody to H1N1 after administration of one and two 7.5 µg doses of Focetria was evaluated in 70 children and adolescents (9-17 years), 60 children (3-8 years), 58 children (12-35 months) and 49 infants (6-11 months). 
Stupanj serozaštite, stupanj serokonverzije izmjereni HI testom i čimbenik serokonverzije izražen kao koeficijent geometrijske sredine HI za anti-HA protutijelo na H1N1 nakon primjene jedne ili dviju doza od 7,5 µg Focetrie je procijenjen u 70 djece i adolescenata (9-17 godina), 60 djece (3-8 godina), 58 djece (12-35 mjeseci) te 49 dojenčadi (6-11 mjeseci).
- Except for Table 1, all tables will be based on number of reactions (presented on PT level, sorted by System Organ Class [SOC] and High Level Term [HLT]) and not number of cases. 
- Izuzev tablice 1., sve će se tablice temeljiti na broju reakcija (predstavljeno na PT razini,
Warnings and precautions Talk to your doctor or nurse before having this vaccine. 
Obratite se svom liječniku ili medicinskoj sestri prije primanja ovog cjepiva
It is provided in a vial containing ten doses (0.5 ml each) for injection. 
Isporučena je u bočici koja sadrži deset doza (0,5 ml svaka) za injekciju.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I)
“Possible side effects” may affect your ability to drive or use tools or machines. 
"Nuspojave" mogu utjecati na sposobnost upravljanja vozilima i rada na strojevima.
A clinical trial (study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 471 children from 6 months to 17 years of age. 
Kliničko ispitivanje (studija V87P6) provedeno je s cjepivom protiv virusa H5N1 u kombinaciji s adjuvansom MF59C.1 na 471 djetetu u dobi od 6 mjeseci do 17 godina.
Study V87P1 Elderly Booster (6 months after 2nd dos e) 
Studija V87P1 starije osobe booster (6 mjeseci nakon 2. doze)
The vaccine should not be administered intravascularly or subcutaneously. 
Cjepivo se ne smije primijeniti intravaskularno ili supkutano.
A Phase II clinical trial (Study V87P1) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant in 312 healthy adults. 
Kliničko ispitivanje Faze II (Studija V87P1) provedeno je s cjepivom protiv virusa H5N1 u kombinaciji s adjuvansom MF59C.1 u 312 zdravih odraslih osoba.
Cardiac disorders Palpitation, tachycardia. 
Palpitacija, tahikardija.
• Post-marketing surveillance 
• Praćenje nakon stavljanja lijeka u promet
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). 
Rezultati MN testiranja na virus A/Vietnam/1194/2004 ukazuju na stopu serozaštite od 99% (95%CI: 94-100), stopu serokonverzije u rasponu od 97% (95%CI): 91-99) do 99% (95%CI: 96-100) i GMR u rasponu od 29 (95%CI: 25-35) do 50 (95%CI: 44-58).
(see section 4.8). 
(vidjeti dio 4.4).
Between uses, return the multidose vial to the recommended storage conditions between 2° and 8° C. The multidose vial should preferably be used within 24 hours after first withdrawal. 
Između uporaba vratite višedoznu bočicu na preporučene uvjete čuvanja između 2 °C i 8 °C.
The following information is intended for healthcare professionals only: Multidose vial: Vial containing 10 doses (0.5 ml each) for injection. 
Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Jednodozna bočica: 1 bočica sadrži jednu dozu (0,5 ml) za injekciju
Water for injections. 
Tiomersal, Voda za injekcije.
Ready-to-use syringe, containing a single dose of 0.5 ml for injection. 
Štrcaljka spremna za primjenu sadrži jednostruku dozu za injekciju od 0,5 ml.
From Post-marketing surveillance with adjuvanted interpandemic trivalent vaccines with composition similar to Foclivia (an MF59.1 adjuvanted H1N1 pandemic vaccine), the following additional adverse reactions have been reported: 
Tijekom praćenja nakon stavljanja u promet adjuvantiranih interpandemijskih trovalentnih cjepiva sastava sličnog Focliviji (H1N1 pandemijsko cjepivo adjuvantirano s MF59C.1), prijavljene su sljedeće dodatne nuspojave:
General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering 
Često (>1/100 i <1/10): crvenilo na mjestu injekcije, oteknuće na mjestu injekcije, otvrdnuće na mjestu injekcije, ekimoza i bol na mjestu injekcije, vrućica, malaksalost, umor i tresavica
Fever ≥ 38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE 
Vrućica ≥38°C to 38,9°C Vrućica 39°C to 39,9°C Vrućica ≥ 40° C
- have experienced serious allergic reaction (i.e. life-threatening) to any of the constituents of Foclivia, - are allergic (hypersensitive) to influenza vaccines or any of the ingredients of Foclivia, - are allergic to eggs, chicken protein, - are allergic to any antibiotic, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80. 
- alergični (preosjetljivi) na cjepiva protiv gripe ili bilo koji sastojak Foclivije, - alergični na jaja, pileću bjelančevinu, - alergični na bilo koji antibiotik, formaldehid, cetiltrimetilamonij bromid (CTAB) i polisorbat 80.
It is provided in a vial containing a single dose (0.5 ml) for injection. 
Isporučena je u bočici koja sadrži jednostruku dozu (0,5 ml) za injekciju.
Rare (>1/10,000, <1/1,000): Thrombocytopenia (some very rare cases were severe with platelet counts less than 5.000 per mm3). 
Trombocitopenija (vrlo rijetki slučajevi su bili ozbiljni, u kojima se broj trombocita spustio na manje od 5000 po mm3)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR SYRINGE 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA ZA ŠTRCALJKU
Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HemoAgglutinin (HA)/dose adjuvanted) were administered three weeks apart to 156 subjects. 
Dvije doze cjepiva koje sadrži virus H5N1 (A/Vietnam/1194/2004; 7,5 µg hemaglutinina (HA) / doza adjuvantirano) primijenjene su u razmaku od tri tjedna na 156 ispitanika.
Seroconversion factor(95%CI)** 
Čimbenik serokonverzije (95%CI)**
How Foclivia is given 
Kako se daje FOCLIVIA
Prior to administration, the withdrawn vaccine should be allowed to reach room temperature. 
Prije primjene cjepivo treba ostaviti da dostigne sobnu temperaturu.
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in elderly >60 years of age, measured by SRH and HI assays were as follows: 
Stopa serozaštite*, stopa serokonverzije* i čimbenik serokonverzije** za anti-Ha protutijela na virus H5N1 A/turkey/Turkey/05 nakon 2. doze u osoba starijih od 60 godina, izmjereni SRH i HI testovima bili su sljedeći:
Seroprotection rate (95% CI) Day 43 Seroconversion factor (95% CI) Day 43 to Day 1 Seroconversion rate (95% CI) Day 43 
(95% CI) 43. dan do 1. dan Stopa serokonverzije (95% CI) 43. dan
0.5 ml in single-dose vial (type I glass) with stopper (halo-butyl rubber). 
0,5 ml u jednodoznoj bočici (staklo tipa I) s gumenim čepom (halo-butilna guma).
Package leaflet: Information for the user Foclivia suspension for injection in multidose container 
Uputa o lijeku: Informacije za korisnika Foclivia suspenzija za injekciju u višedoznom spremniku
MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 27% (17-39) (V87P1) to 39% (32-46) (V87P13) and seroconversion rate of 36% (29-43) for study V87P13. 
Rezultati MN analize za klinička ispitivanja u gornjoj tablici ukazali su na stopu serozaštite od virusa A/turkey/Turkey/05 u rasponu od 27% (17-39) (V87P1) do 39% (32-46) (V87P13) te stopu serokonverzije od 36% (29-43) za studiju V87P13.
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 measured by SRH assays were as follows: 
Stopa serozaštite*, stopa serokonverzije* i čimbenik serokonverzije** za anti-Ha protutijela na virus H5N1 A/Vietnam/1194/2004 izmjereni SRH testovima bili su sljedeći:
Fever ≥38°C to 38.9°C Fever 39°C to 39.9°C Fever ≥ 40° C Any other AE 
Vrućica ≥38°C to 38,9°C Vrućica 39°C to 39,9°C Vrućica ≥ 40° C Bilo koji drugi štetni događaj
Single dose vial: 1 vial containing a single dose (0.5 ml) for injection Instructions for administration of the vaccine: 
Bočica sadrži 10 doza (po 0,5 ml) za injekciju Upute za primjenu cjepiva:
All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively. 
Svi spontani štetni događaji (SOC, HLT, i PT) koje su se javile u trudnica, stratificirani prema vrsti izvještaja (medicinski potvrđeno ili medicinski nepotvrđeno), za razdoblje obuhvaćeno izvještajem i skupno.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 10-DOSE VIAL 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA ZA 10-DOZNU BOČICU
* propagated in fertilised hens' eggs from healthy chicken flocks ** expressed in microgram haemagglutinin. 
7,5 mikrograma** po dozi od 0,5 ml * umnoženi u oplođenim kokošjim jajima iz jata zdravih kokoši ** izraženo u mikrogramima hemaglutinina.
Seroconversion factor (95%CI)°° 
Čimbenik serokonverzije (95%CI)°°
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARDBOARD BOX FOR 1-DOSE VIAL 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA ZA 1-DOZNU BOČICU
Very rare (may affect up to 1 in 10,000 people). 
Vrlo rijetko (može se javiti u najviše 1 od 10 000 osoba).
Package leaflet: Information for the user Foclivia suspension for injection in pre-filled syringe 
Uputa o lijeku: Informacije za korisnika Foclivia suspenzija za injekciju u napunjenoj štrcaljki
MN results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from of 57% (50-64) to 79% (68-87) and 55% (48-62) to 58% (47-69) respectively. 
Rezultati MN analize na virus A/Vietnam/1194/2004 ukazuju na stopu serozaštite i serokonverzije u rasponu od 57% (50-64) do 79% (68-87), odnosno od 55% (48-62) do 58% (47-69).
This is as long as medical treatment is available straight away, in case you have an allergic reaction. 
- Međutim, u pandemijskoj situaciji još uvijek možete primiti cjepivo i to samo ukoliko je medicinski tretman odmah dostupan u slučaju da vam se pojavi alergijska reakcija.
MicroNeutralization (MN) results against A/Vietnam/1194/2004 indicate a seroprotection and seroconversion rate ranging from 67% (60-74) to 85% (78-90) and 65% (58-72) to 83% (77-89), respectively. 
Rezultati mikroneutralizacije (MN) analize na virus A/Vietnam/1194/2004 ukazuju na stope serozaštite i serokonverzije u rasponu od 67% (60-74) do 85% (78-90), odnosno od 65% (58-72) do 83% (77-89).
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 eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB). 
Potreban je oprez pri primjeni cjepiva kod osoba s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju pomoćnu tvar navedenu u dijelu 6.1 i na jaja, pileće bjelančevine, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonij bromid (CTAB).
MN results for the clinical studies in the Table above revealed a seroprotection rate against A/turkey/Turkey/05 ranging from 11% (3-25) (study V87P1) to 30% (24-37) (study V87P13) and seroconversion rate of 25% (19-31) for study V87P13. 
A/turkey/Turkey/05 u rasponu od 11% (3-25) (studija V87P1) do 30% (24-37) (studija V87P13) te stopu serokonverzije od 25% (19-31) za studiju V87P13.
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, to thiomersal and to eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB). 
Potreban je oprez pri primjeni cjepiva kod osoba s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na bilo koju pomoćnu tvar navedenu u dijelu 6.1, na tiomersal i na jaja, pileće bjelančevine, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonij bromid (CTAB).
The vaccine should be allowed to reach room temperature before use. 
Prije uporabe cjepivo treba ostaviti da postigne sobnu temperaturu.
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in the adults measured by Single Radial Haemolysis (SRH) assay was as follows: 
Stopa serozaštite*, stopa serokonverzije* i čimbenik serokonverzije** za anti-HA protutijela na virus H5N1 A/Vietnam/1194/2004 u odraslih osoba izmjereni jednosmjernom radijalnom hemolizom (SRH, engl.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/
The seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibody to H5N1 A/Vietnam/1194/2004 in subjects aged over 60 (limited number of subjects were above 70 years of age) measured by SRH assay assessed in two clinical studies were as follows: 
H5N1 A/Vietnam/1194/2004 u ispitanika starijih od 60 godina (ograničen broj ispitanika bio je stariji od 70 godina) izmjereni SRH analizom i procijenjeni u dva klinička ispitivanja bili su sljedeći:
Particular attention should be given to subjects suffering from epilepsy and the physician should inform the subjects (or parents) about the possibility to experience convulsion. 
a liječnik treba osobe (ili roditelje) obavijestiti o mogućnosti pojave konvulzija (vidjeti dio 4.8).
General disorders and administration site conditions Common (>1/100, <1/10): injection site redness, injection site swelling, injection site induration, injection site ecchymosis and injection site pain, fever, malaise, fatigue and shivering The majority of these reactions usually disappear within 1-2 days without treatment. 
Često (>1/100 i <1/10): crvenilo na mjestu injekcije, oteknuće na mjestu injekcije, otvrdnuće na mjestu injekcije, ekimoza i bol na mjestu injekcije, vrućica, opća malaksalost, umor i tresavica
All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively. 
Svi spontani štetni događaji po dobnoj skupini, prema SOC-u, HLT-u i PT-u, stratificirani prema vrsti izvještaja (medicinski potvrđeno ili medicinski nepotvrđeno), za razdoblje obuhvaćeno izvještajem i skupno.
Pandemic Influenza Vaccine (H5N1) (surface antigen, inactivated, adjuvanted) 
Cjepivo protiv pandemijske influence (H5N1) (površinski antigen, inaktivirano, adjuvantirano)
MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.01 (1.78-2.26). 
Rezultati MN analize u studiji V87P13 pokazali su da je omjer srednje geometrijske vrijednosti (GMR) protiv virusa A/turkey/Turkey/05 bio 2,01 (1,78-2,26).
Foclivia was evaluated in adults aged (18 to 60 years old) and elderly (over 60 years old) following a 1, 22 day primary vaccination schedule. 
Foclivia je procijenjena u odraslih osoba (od 18 do 60 godina) i starijih osoba (starijih od 60 godina)
A clinical trial (Study V87P6) was conducted with a H5N1 vaccine combined with MF59C.1 adjuvant (n=334) vs seasonal influenza vaccine (n=137). 
Nuspojave iz kliničkih ispitivanja u djece u dobi od 6 mjeseci do 17 godina Kliničko ispitivanje (Studija V87P6) provedeno je s cjepivom protiv virusa H5N1 u kombinaciji s adjuvansom MF59C.1 (n=334) nasuprot cjepivu protiv sezonske influence (n=137).
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** * measured by SRH assay ≥ 25 mm2 ** geometric mean ratios of SRH 
Čimbenik serokonverzije (95%CI)** * izmjereno SRH analizom ≥25 mm2
Rare (may affect up to 1 in 1,000 people). 
Rijetko (može se javiti u najviše 1 od 1000 osoba).
Frequency of Adverse reactions in clinical trials and postmarketing surveillance is reported hereunder. 
Učestalost nuspojava u kliničkim ispitivanjima i istraživanjima nakon stavljanja cjepiva na tržište je navedena ispod.
- Active substance: 
- Djelatna tvar:
Adverse reactions from clinical trial in children aged 6 months to 17 years 
Vrlo česte reakcije prijavljene kod 146 dojenčadi i male djece u dobi od 6 do 35 mjeseci:
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues of eggs, chicken proteins, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB) of this vaccine. 
Anafilaktička (tj. po život opasna) reakcija u anamnezi, na bilo koji sastojak ovog cjepiva ili na ostatne tvari koje se u cjepivu nalaze u tragovima kao što su jaja, pileće bjelančevine, kanamicin i neomicin sulfat, formaldehid i cetiltrimetilamonij bromid (CTAB).
To be administered intramuscularly into the deltoid muscle. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Intramuskularna primjena u deltoidni mišić.
Seroprotection rate (95%CI)* Seroconversion rate (95%CI)* Seroconversion factor (95%CI)** 
Stopa serozaštite (95%CI)* Stopa serokonverzije (95%CI)* Čimbenik serokonverzije (95%CI)**
Common (may affect up to 1 in 10 people). 
Često (može se javiti u najviše 1 od 10 osoba).
Respiratory, thoracic and mediastinal disorders Cough. 
Poremećaji dišnog sustava, prsišta i sredoprsja
Seroprotection rate (95%CI)° Seroconversion rate (95%CI)° 
HI Stopa serozaštite (95%CI)° Stopa serokonverzije (95%CI)°
MN results in study V87P13 yielded a GMR against A/turkey/Turkey/05 of 2.77 (2.4-3.2). 
Rezultati MN analize u studiji V87P13 pokazali su da je omjer srednje geometrijske vrijednost (GMR) protiv virusa A/turkey/Turkey/05 bio 2,77 (2,4-3,2).
Posology 
Skvalen
Study V87P1 21 days after 2nd dose N=84 
Studija V87P1 21 dan nakon 2. doze N=84
Seroprotection rate*, seroconversion rate* and the seroconversion factor** for anti-HA antibodies to H5N1 A/turkey/Turkey/05 after the 2nd dose in adults 18-60 years of age, measured by SRH and HI assays were as follows: 
H5N1 A/turkey/Turkey/05 nakon 2. doze u odraslih osoba u dobi od 18 do 60 godina, izmjereni SRH
Headache, dizziness, somnolence, syncope. 
Poremećaji živčanog sustava Glavobolja, omaglica, pospanost, sinkopa.
Study V87P13 21 days after 2nd dose N=66 
Studija V87P13 21 dan nakon 2. doze N=66
Study V87P13 21 days after 2nd dose N=69 
Studija V87P13 21 dan nakon 2. doze N=69
Study V87P13 21 days after 2nd dose N=128 
Studija V87P13 21 dan nakon 2. doze N=128