natgillin/translations-raw huggingface dataset:
There is currently no evidence to indicate that Prepandrix may be associated with a risk of narcolepsy. 
Trenutno nema dokaza koji bi upućivali na moguću povezanost cjepiva Prepandrix s rizikom od narkolepsije.
The frequency of side effects was lower in the group of children who received half of the adult dose. 
Učestalost nuspojava je bila niža u grupi djece koja su primila polovicu doze za odrasle.
In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge. 
tri do četiri dana nakon opterećenja sve su životinje umrle ili morale biti eutanazirane jer su bile na umoru.
In the event of either being observed (including rubber particles from the stopper), discard the vaccine. 
U slučaju da primijetite nešto od navedenog (uključujući i komadiće gume od čepa), bacite cjepivo.
Prepandrix contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 mg) per dose. 
Prepandrix sadrži natrij i kalij Prepandrix sadrži manje od 1 mmol natrija (23 mg) i manje od 1 mmol kalija (39 mg) po dozi, tj.
In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (76.6%), muscle aches (46.8%), fatigue (43.6%), headache (25.3%) and joint pain 
U odraslih osoba u dobi od 18 do 60 godina, najčešće prijavljene nuspojave nakon cijepljenja bile su bol na mjestu injiciranja (76,6%), tupi bolovi u mišićima (46,8%), umor (43,6%), glavobolja (25,3%) i bolovi u zglobovima (13,5%).
MARKETING AUTHORISATION NUMBER(S) EU/1/08/453/002 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/453/002
Based on very limited data, adults aged >80 years may require a double dose of Prepandrix on an elected date and again after an interval of at least three weeks in order to achieve an immune response (see section 5.1). 
Na temelju vrlo ograničenih podataka, za postizanje imunološkog odgovora u odraslih osoba starijih od 80 godina može biti potrebna dvostruka doza cjepiva Prepandrix, na odabrani datum i ponovno nakon najmanje tri tjedna (vidjeti dio 5.1).
• Tingling or numbness of the hands or feet 
• trnci ili utrnulost šaka ili stopala
Rare: Neuralgia, transient thrombocytopenia. 
Rijetko: Neuralgija, prolazna trombocitopenija
Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution. 
Kontrolnu skupnu sačinjavali su tvorovi imunizirani samo s adjuvansom, cjepivom bez adjuvansa (15 mikrograma HA) ili s fiziološkom otopinom s fosfatnim puferom.
Dispose of in accordance with local regulations 
Zbrinuti sukladno nacionalnim propisima.
In other clinical studies where children 6 months to 17 years received Prepandrix, 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 Prepandrix, primijećena je povećana učestalost nekih nuspojava (uključujući bol na mjestu injekcije, crvenilo i vrućicu) nakon primjene druge doze u djece mlađe od 6 godina.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 May 2008 
Datum prvog odobrenja: 14. svibnja 2008.
After one priming dose 
Nakon jedne početne doze
1 Geometric Mean Titre 
1 geometrijska srednja vrijednost titra
GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgium 
GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgija
The side effects listed below have happened with H1N1 AS03-containing vaccines. 
Niže navedene nuspojave su zabilježene s H1N1 cjepivima koja sadrže AS03.
After mixing, the vaccine should be used within 24 hours. 
Nakon miješanja, cjepivo treba upotrijebiti unutar 24 sata.
What Prepandrix contains 
Što Prepandrix sadrži
The immunological response may be diminished if the patient is undergoing immunosuppressant treatment. 
Imunološki odgovor može biti smanjen u bolesnika na imunosupresivnoj terapiji.
Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment. 
15, 5, 1,7 ili 0,6 mikrograma hemaglutinina ispitivane su u pokusu homolognog opterećenja, a doze od 15, 7,5, 3,8 ili 1,75 mikrograma hemaglutinina u pokusu heterolognog opterećenja.
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown. 
Klinička važnost titra inhibicije hemaglutinacije (HI) ≥1:40 u djece nije poznata.
Irritability 
razdražljivost
Viral shedding into the upper respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk of viral transmission. 
U usporedbi s kontrolnom skupinom izlučivanje virusa u gornje dišne putove također je bilo smanjeno, ukazujući na smanjen rizik od prijenosa virusa.
• Diarrhoea, vomiting, stomach pain, feeling sick 
• proljev, povraćanje, bol u trbuhu, mučnina
In subjects > 60 years of age, the most frequently reported adverse reaction after vaccination was injection site pain (32.6%). 
U bolesnika starijih od 60 godina, najčešće prijavljena nuspojava nakon cijepljenja bila je bol na mjestu injiciranja (32,6%).
Prior to administration, the two components should be mixed. 
Prije primjene navedene dvije komponente trebaju se pomiješati.
Excipient with known effect The vaccines contains 5 micrograms thiomersal (see section 4.4). 
Cjepivo sadrži 5 mikrograma tiomersala (vidjeti dio 4.4).
*propagated in eggs **expressed in microgram haemagglutinin 
*umnožen na jajima **izraženo u mikrogramima hemaglutinina
After two priming doses 
Nakon dvije početne doze
The second dose should be given after an interval of at least three weeks and up to twelve months after the first dose. 
Drugu dozu cjepiva treba primijeniti nakon razmaka od najmanje tri tjedna, a najviše dvanaest mjeseci nakon prve doze.
The reproductive toxicity studies have been conducted using Prepandrix containing A/Vietnam/1194/2004. 
Ispitivanja reproduktivne toksičnosti provedena su s cjepivom Prepandrix koji je sadržavao soj A/Vietnam/1194/2004.
For instructions on mixing of the medicinal product before administration, see section 6.6. 
Za upute o miješanju lijeka prije primjene vidjeti dio 6.6.
One pack of Prepandrix consists of: 
Jedno pakiranje cjepiva Prepandrix sadrži:
At day 42, the anti-HA antibody seroconversion rate was 98%, all subjects were seroprotected and the seroconversion factor was 88.6. 
Stopa serokonverzije anti-HA protutijela je 42. dana bila 98%, seroprotekcija je postignuta u svih ispitanika, a faktor serokonverzije bio je 88,6.
Before the vaccine is mixed: 
Prije miješanja cjepiva:
Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively. 
Od životinja koje su primile cjepivo s adjuvansom, njih 87% bilo je zaštićeno od letalnog homolognog a njih 96% od letalnog heterolognog opterećenja.
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 liječniku ili medicinskoj sestri.
The vial should be shaken prior to each administration and inspected visually for any foreign particulate matter and/or abnormal physical appearance. 
Prije svake primjene, bočicu treba protresti i vizualno pregledati na prisutnost stranih čestica i/ili promjenu fizičkog izgleda.
Clinical data in children less than 6 years of age who received two doses of pandemic preparedness or zoonotic influenza vaccine (H5N1) indicate an increase in frequency of fever (axillary≥38°C) after the administration of the second dose. 
Klinički podaci u djece mlađe od 6 godina koja su primila dvije doze cjepiva spremnog protiv pandemijske influence (engl. pandemic preparedness vaccine) ili cjepiva protiv zoonozne influence (engl. zoonotic influenza vaccine) H5N1 ukazuju na povećanu učestalost vrućice (≥ 38ºC aksilarno) nakon primjene druge doze.
Very common: may affect more than 1 in 10 people 
Ostale nuspojave: Vrlo česte: mogu se javiti u više od 1 na 10 osoba
It is recommended to equip the syringe with a needle gauge not larger than 23G. 
Ne preporučuje se koristiti štrcaljku s iglom čiji je promjer veći od 23-G.
Do not use the suspension and the emulsion after the expiry date which is stated on the carton. 
Suspenziju i emulziju se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza oznake „EXP“.
For storage conditions after mixing of the medicinal product, see section 6.3. 
Uvjete čuvanja nakon miješanja lijeka vidjeti u dijelu 6.3.
Prepandrix contains thiomersal 
Prepandrix sadrži tiomersal
• Active substance: Split influenza virus, inactivated, containing antigen* equivalent to: 
• Djelatna tvar: fragmentirani virus influence, inaktivirani, sadrži antigen* koji odgovara soju:
A difference in the frequency of local and general solicited adverse reactions between half adult and adult doses was observed after each dose. 
Nakon svake doze zamijećena je razlika u učestalosti lokalnih i općih praćenih nuspojava između pola doze za odrasle i cijele doze za odrasle.
The emulsion is a whitish to yellowish homogeneous milky liquid. 
Emulzija je bjelkasta do žućkasta mliječna homogena tekućina.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER GSK Biologicals, Rixensart - Belgium 
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GSK Biologicals, Rixensart - Belgija
After mixing, use the vaccine within 24 hours. 
Nakon miješanja, cjepivo upotrijebite unutar 24 sata.
Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly. 
Svaka doza cjepiva od 0,5 ml povuče se u štrcaljku za injekciju od 1 ml te se primjenjuje u mišić.
The European Medicines Agency has deferred the obligation to submit the results of studies with Prepandrix in one or more subsets of the paediatric population in influenza infection caused by an influenza strain contained in the vaccine or related to a strain contained in the vaccine. 
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja cjepiva Prepandrix u jednoj ili više podskupina pedijatrijske populacije s infekcijom influence uzrokovane sojem virusa influence sadržanog u cjepivu ili povezane sa sojem sadržanim u cjepivu. (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
If the mixed vaccine is stored in a refrigerator, it should be allowed to reach room temperature (for a minimum of 15 minutes) before each withdrawal. 
Ako se pripremljeno cjepivo čuva u hladnjaku, prije svake primjene treba pričekati da se zagrije na sobnu temperaturu (najmanje 15 minuta).
Suspension: multidose vial containing the antigen, Emulsion: multidose vial containing the adjuvant. 
Za suspenziju: višedozna bočica koja sadrži antigen, Za emulziju: višedozna bočica koja sadrži adjuvans.
Your doctor or nurse will give you Prepandrix. 
Prepandrix će Vam dati liječnik ili medicinska sestra.
The vaccine should be administered in accordance with the recommended posology (see section 4.2). 
Cjepivo se treba primjenjivati sukladno preporučenom doziranju (vidjeti dio 4.2).
In children/adolescents (aged up to 20 years), these studies have indicated an additional 1.4 to 8 cases in 100,000 vaccinated subjects. 
U djece/adolescenata (u dobi do 20 godina) ta su ispitivanja pokazala 1,4 do
The seroprotection rate against A/Indonesia 21 days after booster vaccination was 92% and 69.2% at day 180. 
Stopa seroprotekcije prema A/Indonesia 21 dan nakon docjepljivanja bila je 92%, a 180. dana 69,2%.
Gastrointestinal disorders Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea) 
Poremećaji probavnog sustava Manje često: gastrointestinalni simptomi (poput proljeva, povraćanja, bola u abdomenu, mučnine)
The vaccine should be administered in accordance with the recommended posology (see section 3 “How Prepandrix is given”). 
Cjepivo treba primjenjivati sukladno preporučenom doziranju (vidjeti dio 3. „Kako se primjenjuje
“Possible side effects” may affect your ability to drive or use tools or machines. 
Upravljanje vozilima i strojevima Pojedine nuspojave navedene u dijelu 4. „Moguće nuspojave“ mogu utjecati na Vašu sposobnost vožnje, korištenja alata ili upravljanja strojevima.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared with H5N1 subtype strains (see section 5.1). 
Ova indikacija temelji se na podacima o imunogenosti, dobivenim na zdravim ispitanicima starijim od 18 godina, nakon primjene dviju doza cjepiva koje je sadržavalo sojeve podtipa H5N1 (vidjeti dio
Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose are recommended. 
Stoga se nakon svake doze preporučuje kontrola tjelesne temperature i provođenje mjera za njezino snižavanje (poput davanja paracetamola ili drugih lijekova za snižavanje vrućice).
* propagated in eggs ** haemagglutinin 
* umnožen na jajima ** hemaglutinin
In addition, 44.8% and 56.1% of subjects in respective dose groups had a 4-fold increase in serum neutralising antibody titres from day 0 to day 42 and 96.6% and 100% of subjects had a titre of at least 1:80 at day 42. 
Uz to, 44,8% odnosno 56,1% ispitanika iz odgovarajućih doznih skupina imalo je četverostruki porast titra neutralizirajućih protutijela u serumu od 0. do 42. dana, a na 42. dan je 96,6% odnosno 100% ispitanika imalo titar od najmanje 1:80.
The seroprotection rate, booster seroconversion rate and booster factor against A/Indonesia/5/2005 21 days after booster vaccination was 100%, 99.7% and 123.8, respectively. 
Stopa seroprotekcije, stopa serokonverzije nakon docjepljivanja i faktor docjepljivanja protiv A/Indonesia/5/2005, 21 dan nakon docjepljivanja, bili su redom 100%, 99,7% i 123,8.
In addition, all subjects had neutralising antibody titres of at least 1:80. 
Uz to, svi ispitanici imali su titar neutralizirajućih protutijela od najmanje 1:80.
Before the vaccine is given, the two parts will be mixed together. 
Prije primjene cjepiva, dvije komponente moraju se međusobno pomiješati.
The administration of a second half adult or an adult dose did not enhance the reactogenicity, except for rates of general symptoms which were higher after the second dose, particularly for rates of fever in <6 year olds. 
Primjena druge polovice doze ili cijele doze za odrasle nije pojačala reaktogenost, osim za stope općih simptoma koje su bile veće nakon druge doze, osobito stope vrućice u djece mlađe od 6 godina.
Prepandrix is not intended to be given at the same time as some other vaccines. 
Prepandrix nije namijenjen za istodobnu primjenu s drugim cjepivima.
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14). 
U svakom pokusu, četiri skupine po šest tvorova imunizirano je intramuskularno AS03-adjuvantiranim cjepivom koje sadrži hemaglutinin dobiven iz soja H5N1/A/Vietnam/1194/04 (NIBRG-14).
The suspension is a colourless light opalescent liquid. 
Suspenzija je bezbojna, blago opalescentna tekućina.
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 5ml izvuče cijeli sadržaj bočice s adjuvansom i doda u bočicu s antigenom.
Immune system disorders Anaphylaxis, allergic reactions 
Anafilaksija, alergijske reakcije
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) 
Prepandemijsko cjepivo protiv influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
Day 180 N=138 
180. dan N=138
Immune response to A/Vietnam/1194/2004 (D42) 61 to 70 years 
Imunološki odgovor na A/Vietnam/1194/2004 (D42) 61 do 70 godina
The anti-HA responses were as follows: 
Odgovori anti-HA protutijela su bili sljedeći:
After two doses given 21 days or 6 months apart, 96.0% of subjects had a 4-fold increase in serum neutralising antibody titre and 98-100% had a titre of at least 1:80. 
Nakon dvije doze primijenjene u razmacima od 21 dan ili 6 mjeseci, 96,0% ispitanika imalo je četverostruki porast titra neutralizirajućih protutijela u serumu, a 98-100% imalo je titar od najmanje
The mixed vaccine is a whitish to yellowish homogeneous milky liquid emulsion. 
Pripremljeno cjepivo je bjelkasta do žućkasta mliječna homogena emulzija.
After mixing with adjuvant emulsion: 10 doses of 0.5 ml 
Nakon miješanja s emulzijom adjuvansa: 10 doza od 0,5 ml
Keep this vaccine out of the sight and reach of children. 
Kako čuvati Prepandrix Čuvajte ovo cjepivo izvan pogleda i dohvata djece.
Against A/Vietnam 21 days after boosting with A/Vietnam N=46 
anti-HA protutijelo protiv A/Vietnam 21 dan nakon docjepljivanja s A/Vietnam N=46
These side effects may also happen with Prepandrix. 
Te nuspojave mogu se pojaviti i s cjepivom Prepandrix.
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 PAKIRANJU PAKIRANJE KOJE SADRŽI 1 PAKIRANJE S 50 BOČICA SUSPENZIJE I 2 PAKIRANJA S
Prepandrix may be used in lactating women. 
Prepandrix se može primjenjivati kod žena koje doje.
The seroprotection rates 6, 12 and 24 months after vaccination were as follows: 
Stope seroprotekcije 6, 12 i 24 mjeseca nakon cijepljenja su bile sljedeće:
Very limited data in seronegative subjects >80 years of age (N=5) showed that no subject achieved seroprotection following two administrations of a single dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1). 
Vrlo ograničeni podaci u seronegativnih ispitanika >80 godina (N=5) pokazali su da nitko od ispitanika nije postigao seroprotekciju nakon dvije primjene jednostruke doze AS03-adjuvantiranog cjepiva koje sadrži 3,75 µg hemaglutinina dobivenog iz soja A/Vietnam/1194/2004 (H5N1).
There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study. 
U prospektivnom kliničkom ispitivanju u kojem se pratilo više od 100 trudnoća nije zabilježen povećan rizik od nuspojava.
The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, water for injections 
Drugi sastojci su: polisorbat 80, oktoksinol 10, tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, magnezijev klorid, voda za injekcije
6-9 years 
6-9 godina
Active immunisation against H5N1 subtype of Influenza A virus. 
Aktivna imunizacija protiv virusa influence tipa A, podtipa H5N1.
3 to 5 years 
3 do 5 godina
Month N=35 
mjesec N=35
If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. 
Ako je potrebna istodobna primjena s drugim cjepivom, cijepljenje treba provesti na različitim udovima.
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically using ferret challenge models. 
U nekliničkom ispitivanju procjenjivala se sposobnost induciranja zaštite protiv homolognih i heterolognih sojeva u cjepivu pomoću modela primjene na tvorovima.
21 days after 2nd dose 
21 dan nakon 2. doze
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Prepandrix 
NAZIV LIJEKA Emulzija za emulziju za injekciju za Prepandrix
Double dose (N=81) 
Dvostruka doza (N=81)
BATCH NUMBER Lot: 
13. BROJ SERIJE Lot
How Prepandrix works 
Kako djeluje Prepandrix
2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80 
2 četverostruko povećanje titra neutralizirajućih protutijela u serumu 3 % ispitanika koji su dosegnuli titar neutralizirajućih protutijela u serumu od najmanje 1:80
Skin and subcutaneous tissue disorders Common: ecchymosis at the injection site, sweating increased Uncommon: pruritus, rash 
Poremećaji kože i potkožnog tkiva Često: ekhimoza na mjestu injiciranja, pojačano znojenje Manje često: pruritus, osip
3-5 years 
3-5 godina
Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05. 
Tvorovi su cijepljeni na 0. i 21. dan, a 49. dana intratrahealnim putem opterećeni su letalnom dozom H5N1/A/Vietnam/1194/04 ili heterolognim H5N1/A/Indonesia/5/05.
Double dose (N=131) 
Dvostruka doza (N=131)
Seroprotection rate1 
Stopa seroprotekcije1
21 days after 1st dose N=55 
21 dan nakon 1. doze N=55
STATEMENT OF ACTIVE SUBSTANCE(S) After mixing, 1 dose (0.5 ml) contains: 
NAVOĐENJE DJELATNE(IH) TVARI Nakon miješanja, 1 doza (0,5 ml) cjepiva sadrži:
Very common: headache Uncommon: paraesthesia, somnolence, dizziness 
Manje često: parestezije, somnolencija, omaglica
21 days after 2nd dose N=48 
21 dan nakon 2. doze N=48
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
Odgovor protutijela može biti nedostatan u bolesnika koji boluju od endogene ili jatrogene imunosupresije.
6 to 9 years 
6 do 9 godina
• Feeling tired 
• osjećaj omaglice
Twenty-one days after the second dose, the seroprotection rate and the vaccine response rate against A/Vietnam/1194/2004 in subjects who received the vaccine 6 months apart were 89.6% and 95.7%, respectively. 
Dvadeset i jedan dan nakon druge doze, stopa seroprotekcije prema soju A/Vietnam/1194/2004 u ispitanika koji su primili cjepivo u razmaku od 6 mjeseci iznosila je 89,6%, a stopa odgovora na cjepivo 95,7%.
In this study, cross-reactive immune responses against A/Indonesia/5/2005 were also observed. 
U tom su ispitivanju primijećeni i imunološki odgovori križne reaktivnosti na soj A/Indonesia/5/2005.
Clinical studies have evaluated the incidence of adverse reactions in approximately 5,000 subjects 18 years old and above who received Prepandrix containing A/Vietnam/1194/2004 (H5N1) strain with at least 3.75 µg HA. 
U kliničkim ispitivanjima je procijenjena incidencija nuspojava u oko 5 000 ispitanika u dobi od 18 i više godina, koji su primili Prepandrix koji sadrži soj A/Vietnam/1194/2004 (H5N1) s najmanje 3,75 µg hemaglutinina.
There are no data with Prepandrix using the subcutaneous route. 
Nema podataka o primjeni cjepiva Prepandrix supkutanim putem.
How to store Prepandrix 
Kako primjenjivati Prepandrix
Blood and lymphatic system disorders Common: lymphadenopathy 
Poremećaji krvi i limfnog sustava
It is best to see how Prepandrix affects you before you try these activities. 
Prije nego počnete s tim aktivnostima, najbolje je provjeriti kako Prepandrix djeluje na Vas.
24 months after vaccination 
24 mjeseca nakon cijepljenja
AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin 
AS03 adjuvans sadrži skvalen, DL-α-tokoferol i polisorbat 80 * hemaglutinin
6 months after vaccination 
6 mjeseci nakon cijepljenja
Single dose (N=140) 
Jednostruka doza (N=140)
No post-marketing surveillance data are available following Prepandrix administration. 
Nema podataka iz postmarketinškog praćenja nakon primjene cjepiva Prepandrix.
OTHER SPECIAL WARNING(S), IF NECESSARY Suspension and emulsion to be mixed before administration 
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Suspenziju i emulziju treba pomiješati prije primjene.
At day 42, the anti-HA antibody responses were as follows: 
Odgovor anti-HA antitijela 42. dana je bio sljedeći: