natgillin/translations-raw huggingface dataset:
Taking into account the PRAC Assessment Report on the PSUR for Pumarix, the scientific conclusions of the PRAC are as follows: 
Povjerenstvo za ocjenu rizika na području farmakovigilancije (PRAC) je na temelju ocjene Periodičkog izvješća o neškodljivosti (PSUR) za Pumarix donijelo sljedeće znanstvene zaključke:
At day 42 and six months after the second dose, the anti-HA antibody responses were as follows: 
Odgovori anti-HA protutijela 42. dana i šest mjeseci nakon primjene druge doze bili su sljedeći:
At day 42, 100% of subjects aged 18-60 years and 96.4% of subjects aged >60 years 
Četrdeset i drugog dana, 100% ispitanika od 18 do 60 godina, te 96,4%
In addition, duration a pandemic, resources needed for an in-depth evaluation of Periodic Safety Update Reports in the format as defined in Volume 9a of the Rules Governing Medicinal Product in the European Union may not be adequate for a rapid identification of a new safety issue. 
tijekom trajanja pandemije, resursi potrebni za detaljnu analizu periodičkih izvješća o neškodljivosti lijeka, u formatu koji je zadan u Volumenu 9a Propisa o lijekovima u Europskoj
Day 180 N=104 
180. dan N=104
Grounds recommending the variation to the terms of the Marketing Authorisation 
Osnove za preporuku izmjene uvjeta odobrenja za stavljanje lijeka u promet
Clinical studies have evaluated the incidence of adverse reactions in approximately 4,500 subjects 18 years old and above who received Pumarix or placebo. 
Klinička ispitivanja procijenila su incidenciju nuspojava u oko 4500 osoba starijih od 18 godina koje
If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) 
Ako se pripremljeno cjepivo čuva u hladnjaku, prije svake primjene treba pričekati da se zagrije na sobnu temperaturu (najmanje 15
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
Imunološki odgovor može biti nedostatan u bolesnika s endogenom ili jatrogenom imunosupresijom.
In subjects > 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (58.0%), muscle aches (19.7%), fatigue (13.5%), headache (12.4%) and joint pain 
U osoba starijih od 64 godine, najčešće prijavljene nuspojave nakon cijepljenja bile su: bol na mjestu injiciranja (58,0%), bolovi u mišićima (19,7%), umor (13,5%), glavobolja (12,4%) i bol u zglobovima
The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by means of a 5 ml syringe and by adding it to the vial containing the antigen. 
Cjepivo se priprema tako da se pomoću štrcaljke od 5 ml izvuče cijeli sadržaj bočice s adjuvansom i doda u bočicu s antigenom.
In other clinical studies where children 6 months to 17 years received a similar vaccine containing A/Indonesia/05/2005, increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose in children aged less than 6 years. 
U drugim kliničkim ispitivanjima, u kojima su djeca u dobi od 6 mjeseci do 17 godina primila slično cjepivo koje je sadržavalo soj A/Indonesia/05/2005, primijećena je povećana učestalost nekih nuspojava (uključujući bol na mjestu injekcije, crvenilo i vrućicu) nakon primjene druge doze u djece
The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary. 
Europska agencija za lijekove će svake godine procjenjivati nove informacije o lijeku, te će se tekst
However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be 
Međutim, ako to bude nužno, drugo cjepivo će trebati primijeniti u drugu ruku.
Day 180 N=141 
180. dan N=141
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass). 
Cjepivo se primjenjuje intramuskularno, po mogućnosti u deltoidni mišić ili anterolateralni dio bedra
If you have any further questions on the use of this vaccine, ask your doctor or nurse. 
U slučaju bilo kakvih pitanja u vezi s primjenom ovog cjepiva, obratite se svom liječniku ili
No fertility data are available. 
Nema podataka o utjecaju na plodnost.
Immune response to A/Indonesia/5/2005 Day 42 N=145 
Imunološki odgovor na sojeve A/Indonesia/5/2005 42. dan N=145
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU PAKOVANJE OD 25 BOČICA S EMULZIJOM (ADJUVANS)
This should include data from ongoing studies, or actual use if applicable, of the ‘mock-up' strains and any safety data relevant 
Ovo treba uključivati podatke iz ispitivanja koja su u tijeku, ili ako je primjenjivo iz stvarnih iskustava,
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION (ANTIGEN) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU PAKOVANJE OD 50 BOČICA SA SUSPENZIJOM (ANTIGEN)
All subjects achieved a neutralising antibody titre of at least 1:80 against each of the two strains regardless of the HA type in the vaccine and the previous number of doses. 
Svi ispitanici postigli su titar neutralizirajućih protutijela od najmanje 1:80 prema svakom od dva soja, neovisno o
This adjuvant contains squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams). 
Taj adjuvans sadrži skvalen (10,69 miligrama), DL-α tokoferol (11,86 miligrama) i polisorbat 80 (4,86 miligrama).
- Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. 
- Znakovi alergijske reakcije mogu uključivati kožni osip sa svrbežom, nedostatak zraka i
They may also happen with Pumarix. 
One se mogu javiti i pri primjeni cjepiva Pumarix.
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, stoga može doći do reakcije
Fatal and/or life-threatening reactions - for each Preferred Term (PT), including the proportion of fatal reports 
Izvješće će sadržavati sljedeće tablice zbirnih podataka prema dogovorenim predlošcima: Smrtonosne i/ili životno ugrožavajuće nuspojave - za svaku preferirani naziv (PT), uključujući Neželjeni događaji od posebnog interesa (PT)
Also fever occurred more often in children aged 6-9 years compared to the children aged 3-5 years. 
Vrućica se također javljala češće u djece od 6 do
- Periodicity will be reviewed by the MAH and the (Co)Rapporteur at 3 monthly intervals. 
- Učestalost podnošenja izvješća revidirat će se u tromjesečnim intervalima od strane nositelja
In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing three different doses of H5N1 antigen (7.5, 3.8 and 1.9 µg of HA antigen) adjuvanted with the standard dose or half dose of AS03. 
U tom ispitivanju zaštite, tvorovi (šest tvorova/skupina) su cijepljeni intramuskularno predloženim cjepivom koje je sadržavalo tri različite doze antigena H5N1 (7,5; 3,8 i 1,9 µg HA antigena), sa standardnom dozom ili pola doze adjuvansa AS03.
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 
Volumen dobiven nakon miješanja 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara
Immune response against A/Indonesia/5/2005 (H5N1) 
Imunološki odgovor na soj A/Indonesia/5/2005 (H5N1) Odrasli
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 (H5N1): 
Imunološki odgovori križne reaktivnosti postignuti cjepivom s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja A/Indonesia/5/2005 (H5N1):
The vaccine should be administered in accordance with the recommended posology (see section 3. 
Cjepivo se treba davati sukladno preporučenom doziranju (vidjeti dio 3. ''Kako se primjenjuje Pumarix'').
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber). 
- dva pakovanja s 25 bočica (staklo tip I) od 2,5 ml emulzije s čepom (butil guma).
These transitory false-positive results may be due to IgM production in response to the vaccine. 
Ovi prolazni, lažno pozitivni rezultati mogući su zbog stvaranja
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
cjepivo protiv pandemijske influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. 
Dokazana kemijska i fizikalna stabilnost u
Redness 
Nuspojave
Excipient with known effect: the vaccine contains 5 micrograms thiomersal For the full list of excipients see section 6.1. 
Pomoćna tvar s poznatim učinkom: cjepivo sadrži 5 mikrograma tiomersala.
Shake before use 
Protresti prije primjene
The per-dose frequency of adverse reactions was as follows: 
Odgovori na anti-HA protutijela bili su sljedeći:
On the basis of the scientific conclusions for Pumarix, the CHMP is of the opinion that the benefitrisk balance of the medicinal product containing the active substance purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 is favourable subject to the proposed changes to the product information. 
Na temelju znanstvenih zaključaka za Pumarix, mišljenje je CHMP-a da je omjer koristi i rizika lijeka koji sadrži djelatnu tvar dijelove pročišćenog antigena inaktiviranog fragmentiranog viriona A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 povoljan pod uvjetom da se provedu predložene
Tel.: + 48 (22) 576 9000 
GSK Commercial Sp. z o.o. Tel.: + 48 (22) 576 9000
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 listed in section 6.1, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde and sodium 
Potreban je oprez prilikom primjene ovog cjepiva osobama s poznatom preosjetljivošću (osim anafilaktičke reakcije) na djelatnu tvar, na neku od pomoćnih tvari navedenih u dijelu 6.1, tiomersal i ostatne tvari (jaja i pileći proteini, ovalbumin, formaldehid i natrijev deoksikolat).
Full dose N=29 
Puna doza N=29
3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT) 
3faktor serokonverzije (tj. omjer GMT vrijednosti nakon i prije cijepljenja)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SUSPENSION VIAL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of this vaccine (listed in section 6) or to anything else that may be present in very small amounts, such as: egg and chicken protein, ovalbumin, formaldehyde or sodium deoxycholate. 
• ako ste prije imali iznenadnu životno ugrožavajuću alergijsku reakciju na bilo koji sastojak ovog cjepiva (navedenih u dijelu 6) ili na bilo koju tvar koja može biti prisutna u tragovima, poput: jaja i pilećih proteina, ovalbumina, formaldehida ili natrijeva deoksikolata.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. 
Kao psihogeni odgovor na ubod iglom, nakon ili čak i prije bilo kojeg cijepljenja može doći do sinkope (gubitka svijesti).
The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate, 
Drugi sastojci su: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat,
Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005. 
Neovisno o tome jesu li su prije šest mjeseci primili jednu ili dvije doze primovakcinacije, stopa seroprotekcije protiv A/Indonesia bio je >80% nakon doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004, a stope seroprotekcije protiv A/Vietnam bile su >90% nakon doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Indonesia/05/2005.
Pumarix may be used in lactating women. 
Dojenje Pumarix se može primjenjivati u dojilja.
In the consistency study (Q-Pan-H5N1-002), a 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was at day 42 achieved in 65.5% of subjects aged 18-60 years and in 24.1% of subjects over 60 years of age. 
U ispitivanju konzistencije (Q-Pan-H5N1-002) 42. dana postignut je četverostruki porast neutralizirajućih protutijela protiv soja A/Vietnam/1194/2004 u serumu 65,5% ispitanika od 18 do 60
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR). 
RMP mora se podnijeti istovremeno uz sljedeće Periodičko izvješće o neškodljivosti lijeka (PSUR).
A titre of 1:80 was achieved in 95.7% of subjects at days 21 and 42 and in 85.1% at day 180. 
Dvadeset i prvog, te 42. dana, titar od 1:80 postignut je u 95,7% ispitanika, a 180.-ti dan u 85,1% ispitanika.
OTHER SPECIAL WARNING(S), IF NECESSARY Emulsion to be exclusively mixed with antigen suspension before administration 
Emulziju prije primjene treba pomiješati isključivo sa suspenzijom antigena
The side effects listed below have happened with H1N1 AS03-containing vaccines. 
S H1N1 cjepivima koja sadrže AS03 zabilježene su niže navedene nuspojave.
Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Pumarix suspenzija i emulzija za emulziju za injekciju cjepivo protiv pandemijske influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
• Reactions where the injection was given such as bruising, a hard lump, itching, warmth 
• reakcije na mjestu primjene injekcije poput modrica, otvrdnuća, svrbeža, topline • otečene žlijezde na vratu
The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180. 
Stopa seroprotekcije protiv A/Indonesia 21 dan nakon docjepljivanja bila je 92%, a
Animal studies with Pumarix do not indicate reproductive toxicity (see section 5.3). 
Ispitivanja na životinjama provedena s cjepivom Pumarix ne ukazuju na reproduktivnu toksičnost
Ten days after the booster dose, the seroprotection rate against A/Turkey/Turkey/1/2005 and A/Indonesia/5/2005 was 99.2%. 
A/Turkey/Turkey/1/2005 i A/Indonesia/5/2005 bila je 99,2%.
Uncommon: abdominal pain, vomiting, dyspepsia, stomach discomfort 
Manje često: bol u trbuhu, povraćanje, dispepsija, nelagoda u želucu
Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity 
Manje često: bol u leđima, ukočenost mišićno-koštanog sustava, bol u vratu, grčevi mišića, bol u
This can cause bleeding or bruising. 
• smanjenje broja trombocita u krvi što može uzrokovati krvarenje ili stvaranje modrica.
EXP: 
RMP-a.
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in this vaccine (listed in section 6) or to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde or to sodium deoxycholate. 
• jeste li imali bilo kakvu alergijsku reakciju, osim iznenadne životno ugrožavajuće alergijske reakcije, na bilo koji sastojak ovog cjepiva (naveden u dijelu 6) ili na tiomersal, jaja i pileće proteine, ovalbumin, formaldehid ili natrijev deoksikolat.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS OF EMULSION 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU PAKOVANJE KOJE SADRŽI 1 PAKOVANJE OD 50 BOČICA SA SUSPENZIJOM I 2
OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration 
Suspenziju prije primjene treba pomiješati isključivo s emulzijom adjuvansa.
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 doses of vaccine (5 ml). 
Volumen dobiven miješanjem 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara 10
Immune response to A/Indonesia/5/2005 
Imunološki odgovor na A/Indonesia/5/2005 >60 godina
If any of the side effects below occur, please tell your doctor or nurse immediately: 
Ako dođe do neke od niže navedenih nuspojava, molimo da odmah o tome
Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections 
Pomoćne tvari: natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, voda za
If you have previously received one or two doses of a similar H5N1 AS03-containing vaccine 
Ako ste ranije primili jednu ili dvije doze sličnog H5N1 cjepiva s adjuvansom AS03 • Odrasli stariji od 18 godina: primit ćete jednu dozu cjepiva Pumarix.
In another clinical study (Q-Pan-H5N1-001), anti-HA responses against A/Vietnam/1194/2004 following administration of AS03-adjuvanted vaccine containing 3.75 µg derived from A/Indonesia/5/2005 were as follows: 
U drugom kliničkom ispitivanju (Q-Pan-H5N1-001), zabilježeni su sljedeći anti-HA odgovori protiv soja A/Vietnam/1194/2004 nakon primjene cjepiva s adjuvansom AS03 koje sadrži 3,75 µg dobivenog
In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively. 
U kliničkom ispitivanju (D-Pan-H5N1-012) osobe od 18 do 60 godina primile su dozu cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog ili od soja A/Vietnam/1194/2004 ili Indonesia/5/2005, šest mjeseci nakon što su primili jednu ili dvije inicijalne doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004, i to samo na 0. dan ili na 0. i 21. dan.
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 30°C. 
Nakon miješanja, primijenite cjepivo unutar 24 sata, te nemojte čuvati iznad 30°C.
There are no data with Pumarix using the subcutaneous route. 
Nema podataka o supkutanoj primjeni cjepiva Pumarix.
During the pandemic, the applicant will conduct a prospective cohort study as identified in the 
Za vrijeme pandemije, plan vođenja registra bit će prijavljen kao dio
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre 
3faktor serokonverzije: omjer geometrijske sredine titra (GMT) nakon i prije cijepljenja.
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 manufactured using a different process administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 manufactured using a different 
Jedna doza cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Indonesia/05/2005, proizvedenog različitim postupkom proizvodnje, primijenjena nakon jedne ili dvije doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 proizvedenog različitim
Half dose N=44 
Pola doze N=44
Full dose N=41 
Puna doza N=41
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber). 
- jedno pakovanje s 50 bočica (staklo tip I) od 2,5 ml suspenzije s čepom (butil guma).
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old 
Neovisno o tome jesu li djeca primila pola doze ili cijelu dozu za odrasle, nije zabilježeno povećanje učestalosti nakon druge doze, osim kod nekih nuspojava koje su se javljale češće nakon druge doze, što se osobito odnosi na učestalost vrućice u djece mlađe od
In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21. 
U drugom kliničkom ispitivanju, 39 ispitanika od 18 do 60 godina je primilo dozu cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Indonesia/5/2005 četrnaest mjeseci nakon što su primili dvije doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 i to na 0. i 21. dan.
NAME OF THE MEDICINAL PRODUCT Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Uputa o lijeku: informacija za korisnika Pumarix suspenzija i emulzija za emulziju za injekciju cjepivo protiv pandemijske influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde and sodium deoxycholate) of this vaccine. 
Anamneza anafilaktičke (tj. životno ugrožavajuće) reakcije na bilo koji sastojak ovog cjepiva ili na tvari koje se u cjepivu nalaze u tragovima (jaja i pileći proteini, ovalbumin, formaldehid i natrijev deoksikolat).
In a clinical study (Q-Pan-H5N1-010), a booster dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 was given 15 months after primary vaccination. 
U kliničkom ispitivanju (Q-Pan-H5N1-010) 15 mjeseci nakon primovakcinacije provedeno je docjepljivanje dozom cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Turkey/Turkey/1/2005.
A clinical study (D-H5N1-009), evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of another Pandemic influenza vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany). 
U kliničkom ispitivanju (D-H5N1-009) procjenjivana je reaktogenost u djece od 3 do 5 godina, i od 6 do 9 godina, koja su u razmaku od 21 dan primila dvije doze za odrasle (tj. 0,5 ml) ili dvije polovice doze za odrasle (tj. 0,25 ml) drugog Cjepiva protiv pandemijske influence (H5N1
In a consistency study (Q-Pan-H5N1-002), the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows: 
U ispitivanju konzistencije (Q-Pan-H5N1-002), odgovori anti-hemaglutinin (anti-HA) protutijela 21
Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections 
Pomoćne tvari: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and 
Adjuvans AS03 sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80
Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) post 
Stoga se u male djece (u dobi do približno 6 godina) nakon cijepljenja preporučuje kontrola tjelesne temperature i primjena mjera za snižavanje
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 administered after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from Indonesia/5/2005 
Jedna doza cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Turkey/Turkey/1/2005 primijenjena nakon dvije doze cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja
• one pack containing 50 vials of 2.5 ml suspension (antigen) 
• jednog pakovanja koje sadrži 50 bočica s 2,5 ml suspenzije (antigen) • dva pakovanja koja sadrže po 25 bočica s 2,5 ml emulzije (adjuvans)