natgillin/translations-raw huggingface dataset:
Your doctor or nurse will administer the vaccine in accordance with official recommendations. 
Kako primjenjivati Pandemrix Vaš liječnik ili medicinska sestra će primijeniti cjepivo u skladu sa službenim preporukama.
Adult dose 
Doza za odrasle
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or may need to be delayed. 
Ako se bilo što od navedenog odnosi na Vas, o tome OBAVIJESTITE LIJEČNIKA ILI MEDICINSKU SESTRU jer se u tom slučaju možda cijepljenje ne preporučuje ili se treba odgoditi.
There is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks. 
Daljnji imunološki odgovor javlja se na drugu dozu cjepiva od 0,25 ml koja se primjenjuje nakon razdoblja od tri tjedna.
What Pandemrix is and what it is used for 
Što je Pandemrix i za što se koristi Što je Pandemrix i za što se koristi
Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant. 
Pandemrix se može primiti istovremeno s cjepivom protiv sezonske gripe koje ne sadrži adjuvans.
• Tingling or numbness of the hands or feet 
• Trnci ili utrnulost šaka ili stopala
Information from non-clinical studies: 
Podaci iz nekliničkih ispitivanja
Narcolepsywith or without cataplexy (see section 4.4) 
Narkolepsija s katapleksijom ili bez katapleksije (vidjeti dio 4.4) Somnolencija2
All these side effects were reported very commonly after each dose. 
Nakon svake doze ove su nuspojave prijavljivane vrlo često.
What Pandemrix contains 
Što Pandemrix sadrži
• Generalised skin reactions including facial swelling and urticaria (hives) 
• Generalizirane kožne reakcije uključujući oticanje lica i urtikariju (koprivnjaču)
Children aged 6-35 months 
Djeca u dobi od 6-35 mjeseci
Prophylaxis of influenza caused by A (H1N1)v 2009 virus. 
Profilaksa influence koju uzrokuje virus A (H1N1)v 2009.
The anti-HA antibody responses in healthy subjects aged >60 years who received either one or two doses of 0.5 ml 21 days apart were as follows: 
Odgovor anti-HA antitijela u zdravih ispitanika u dobi >60 godina koji su primili ili jednu ili dvije doze od 0,5 ml, u razmaku od 21 dan, bio je sljedeći:
• Feeling sick, diarrhoea, vomiting, stomach pain 
• Vrućica • Mučnina, proljev, povraćanje, bol u trbuhu
There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with other (H1N1)v vaccines. 
Nema podataka o sigurnosti, imunogenosti ili djelotvornosti koji bi ukazivali na mogućnost zamjene cjepiva Pandemrix drugim (H1N1)v cjepivima.
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 širenje virusa u gornje dišne putove također je bilo smanjeno, ukazujući na smanjen rizik od prijenosa virusa.
The neutralising antibody responses in subjects >60 years were as follows: Serum neutralising antibody 
Odgovor neutralizirajućih protutijela u ispitanika dobne skupine >60 godina bio je sljedeći: Neutralizirajuća protutijela u serumu
• A hard lump and warmth at the injection site 
• Tvrda oteklina i toplina na mjestu injiciranja
• Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation), 
• Reakcije na mjestu injiciranja poput boli, crvenila, modrica, oticanja i topline (upala), tvrda kvržica (masa)
Redness and pruritus at the injection site, fever Uncommon induration and warmth at the injection site, influenza like illness, malaise Post-marketing experience with Pandemrix (H1N1)v Immune system disorders 
vrućica Manje često Otvrdnuće i osjećaj topline na mjestu injiciranja, bolest nalik gripi, malaksalost Postmarketinško iskustvo s cjepivom Pandemrix (H1N1)v
It is not known whether the observed effects would apply to administration of nonadjuvanted seasonal influenza vaccine after a single dose of Pandemrix or when longer dose intervals have elapsed since administration of Pandemrix. 
Nije poznato da li bi se zamijećeni učinak mogao javiti i u slučaju primjene neadjuvantiranog sezonskog cjepiva protiv influence nakon jedne doze cjepiva Pandemrix ili u slučaju da je od primjene cjepiva Pandemrix prošao dulji vremenski period.
Angioedema, generalised skin reactions, urticaria 
Angioedem, generalizirane kožne reakcije, urtikarija
In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (87.8%), fatigue (32.9%), headache (28.1%), arthralgia (17.9%), myalgia (30.0%), shivering (19.4%), injection site swelling (11.5%) and sweating (11.3%). 
U odraslih osoba u dobi od 18 do 60 godina, najčešće prijavljene nuspojave nakon cijepljenja bile su bol na mjestu injiciranja (87,8%), umor (32,9%), glavobolja (28,1%), artralgija (17,9%), mijalgija (30,0%), drhtanje (19,4%), oticanje na mjestu injiciranja (11,5%) i znojenje (11,3%).
In the children who had received two adult (0.5 ml) doses, the seroprotection rates twelve months after the first dose were 100% for children aged 3-5 years and 98.0% for those aged 6-9 years. 
U djece koja su primila dvije doze za odrasle (0,5 ml), stopa seroprotekcije je 12 mjeseci nakon prve doze bila 100% kod djece u dobi od 3-5 godina te 98,0% kod djece u dobi od 6-9 godina.
4according to protocol anti-HA antibody 
4prema planu ispitivanja anti-HA protutijelo
Children aged less than 6 months 
Djeca mlađa od 6 mjeseci
Twelve months after the first dose, the seroprotection rate was 85% in both age groups. 
Dvanaest mjeseci nakon prve doze zabilježena je stopa seroprotekcije od 85% u obje dobne skupine.
Very common Arthralgia, myalgia 
Artralgija, mijalgija
There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v in children aged less than 6 months. 
Iz kliničkih ispitivanja cjepiva Pandemrix (H1N1)v nema podataka o sigurnosti i imunogenosti u djece koja su mlađa od 6 mjeseci.
In subjects > 60 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%). 
U osoba starijih od 60 godina, najčešće prijavljene nuspojave nakon cijepljenja bile su bol na mjestu injiciranja (59,0%), mijalgija (20,6%), umor (17,9%), glavobolja (17,6%) i artralgija (14,3%).
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 miješa tako da se pomoću štrcaljke od 5 ml izvuče cijeli sadržaj bočice s adjuvansom i doda u bočicu s antigenom.
5.0% 5.4% 1.9% 5.8% NA NA NA NA 
5,0% 5,4% 1,9% 5,8% ND ND ND ND
Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs). 
Podaci stoga ukazuju da se Pandemrix može istovremeno primjenjivati s neadjuvantiranim sezonskim cjepivima protiv influence (uz davanje injekcija cjepiva u različite udove).
Neuralgia 
Neuralgija
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), 
• Neurološki poremećaji poput encefalomijelitisa (upala središnjeg živčanog sustava), neuritisa
Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone. 
Istovremena primjena dva cjepiva nije bila povezana s većim stopama lokalnih ili sistemskih reakcija od onih pri samostalnoj primjeni Pandemrix cjepiva.
In a clinical study where a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) was administered 3 weeks after the second dose of Pandemrix (two doses were given 21 days apart), a lower immune response to Fluarix was observed as compared to subjects who had not previously received Pandemrix. 
U kliničkom ispitivanju u kojem je neadjuvantirano sezonsko cjepivo protiv influence (Fluarix, kao ranije navedeno) primijenjeno 3 tjedna nakon druge doze cjepiva Pandemrix (razdoblje između primijenjenih doza bilo je 21 dan), zamijećen je smanjen imunološki odgovor na cjepivo Fluarix u usporedbi s ispitanicima koji ranije nisu primili Pandemrix.
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 25°C. 
Nakon miješanja cjepiva: Nakon miješanja, cjepivo upotrijebiti unutar 24 sata i ne čuvati na temperaturi iznad 25°C.
Clinical trials Blood and lymphatic system disorders 
Klinička ispitivanja Poremećaji krvi i limfnog sustava
The vaccine should be administered in accordance with the recommended posology (see section 4.2). 
Cjepivo treba primijeniti sukladno preporučenom doziranju (vidjeti dio 4.2).
It is preferable that non-adjuvanted seasonal influenza vaccines should be administered before or with the first dose of Pandemrix. 
Poželjno je da se neadjuvantirana sezonska cjepiva protiv influence primjene prije prve doze ili s prvom dozom cjepiva Pandemrix.
INFORMATION IN BRAILLE 
16. PODACI NA BRAILLOVOM PISMU
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pandemrix 
NAZIV LIJEKA Emulzija za emulziju za injekciju za Pandemrix
If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. 
Ako je potrebna istovremena primjena s drugim cjepivom, cijepljenje treba provesti na različitim udovima.
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. 
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.
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 medicinskoj sestri.
It is recommended to equip the syringe with a 23-G needle. 
Preporučuje se koristiti štrcaljku s iglom promjera 23-G.
Twelve months after the first dose, the seroprotection rate was 100% in all age groups and dosage groups. 
Dvanaest mjeseci nakon prve doze stopa seroprotekcije bila je 100% u svim dobnim i doznim skupinama.
Total enrolled subjects2 
Ukupan broj uključenih ispitanika2
Pandemrix contains thiomersal 
Pandemrix sadrži tiomersal
Anaphylaxis, allergic reactions 
Anafilaksa, alergijske reakcije
One dose of 0.25 ml at an elected date. 
Jedna doza cjepiva od 0,25 ml na odabrani datum.
“Possible side effects” may affect the ability to drive or use machines. 
Neki učinci navedeni u dijelu 4. “Moguće nuspojave” mogu utjecati na Vašu sposobnost upravljanja vozilom ili strojevima.
Suspension vial: 
Bočica sa suspenzijom:
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 nulti i 21. dan, a 49. dana intratrahealnim putem opterećeni su letalnom dozom H5N1/A/Vietnam/1194/04 ili heterolognim
What you need to know before you receive Pandemrix 
Što morate znati prije nego primite Pandemrix Nemojte primiti Pandemrix:
Twelve months after the first dose, the seroprotection rates in the children who had received two half (0.25 ml) doses were 90.2% and 100% in those who had received two full (0.5 ml) adult doses. 
Dvanaest mjeseci nakon prve doze, stopa seroprotekcije u djece koja su primila dvije polovice (0,25 ml) doze bila je 90,2% i 100% u onih koji su primili dvije pune (0,5 ml) doze za odrasle osobe.
Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for injection and administered intramuscularly. 
Svaka doza cjepiva od 0,5 ml (cijela doza) ili od 0,25 ml (pola doze) uvuče se u štrcaljku za injekciju od 1 ml te se primjenjuje u mišić.
21 days after 1st dose 
21 dan nakon 1. doze
Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may still be an option if you need protection against A(H1N1)v influenza (see Take special care with Pandemrix). 
Vaš će liječnik umjesto cjepiva Pandemrix obično preporučiti drugo cjepivo (godišnje trovalentno/četverovalentno cjepivo protiv influence), ali ako trovalentna/četverovalentna cjepiva nisu dostupna, a potrebna Vam je zaštita od gripe uzrokovane A(H1N1)v virusom, Pandemrix može biti jedna od opcija (pogledajte dio Upozorenja i mjere opreza).
neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome 
(upale živaca) i vrste paralize poznate kao Guillain-Barré-ov sindrom.
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. 
Zbog toga se nakon svake doze preporučuje praćenje tjelesne temperature te primjena mjera za snižavanje povišene temperature (poput davanja paracetamola ili drugih lijekova za snižavanje vrućice).
One dose of 0.5 ml at an elected date. 
Jedna doza cjepiva od 0,5 ml na odabrani datum.
Two clinical studies evaluated the administration of a half (0.25 ml) dose and a full (0.5 ml) adult dose of Pandemrix in healthy children 10 to 17 years of age. 
Dva klinička ispitivanja procjenjivala su primjenu polovice doze (0,25 ml) ili cijele doze (0,5 ml) za odrasle cjepiva Pandemrix u zdrave djece u dobi od 10 do 17 godina.
• Swollen glands in the neck, armpit or groin 
• Otečene žlijezde na vratu, u pazusima ili preponama
Half adult dose4 
Pola doze za odrasle4
Please see details of the assessment in the CHMP assessment report EMEA/H/C/000832/II/0079 published on the EMA website. 
EMEA/H/C/000832/II/0079 objavljenom na internetskim stranicama Europske agencije za lijekove (EMA).
5all subjects seronegative prior to vaccination anti-HA 
5svi ispitanici koji su prije cijepljenja bili seronegativni anti-HA protutijelo
Children aged 10-17 years 
Djeca u dobi od 10-17 godina
How Pandemrix works 
Kako Pandemrix djeluje
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 pratio ishod u više od 100 trudnoća nije zabilježen povećan rizik od nuspojava.
In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses there was an increase in the rates of injection site reactions and general symptoms after the second dose (see section 4.8). 
U djece dobi od 6 do 35 mjeseci (N=51) koja su primila dvije doze cjepiva od 0.25 ml (polovicu doze za odrasle) s intervalom od 3 tjedna između primijenjenih doza, nakon primjene druge doze zamijećeno je povećanje stope reakcija na mjestu injiciranja, kao i općih simptoma (vidjeti dio 4.8).
Pandemrix contains sodium and potassium 
Pandemrix sadrži natrij i kalij
4according to protocol 
4prema planu ispitivanja
Rare (≥1/10,000 to <1/1,000) 
Često (≥1/100 i <1/10) Manje često (≥1/1000 i <1/100) Rijetko (≥1/10 000 i <1/1000) Vrlo rijetko (<1/10 000)
See section 5.1 regarding immune responses to one and two doses of Pandemrix (H1N1)v, including antibody levels after 6 and 12 months. 
Za imunološke odgovore na jednu i dvije doze cjepiva Pandemrix (H1N1)v, uključujući i razine antitijela nakon 6 i 12 mjeseci vidjeti dio 5.1.
Twelve months after the first dose, the seroprotection rate was as follows: anti-HA antibody 
Šest mjeseci nakon prve doze zabilježene su sljedeće vrijednosti stopa seroprotekcije: anti-HA protutijelo
Vaccination is not recommended in this age group. 
U toj dobnoj skupini cijepljenje se ne preporuča.
A/California/07/2009 (H1N1) derived strain used NYMC X-179A I.M. 
A/California/07/2009 (H1N1) iz kojeg je izveden korišten soj NYMC X-179A i.m.
Fever (>39°C) axillary 
Vrućica (>39°C)
In particular rates of fever (axillary temperature ≥38°C) increased considerably after the second dose. 
Nakon druge doze, osobito su se značajno povećale stope javljanja vrućice (aksilarna temperatura
tection rate1 92.7% 
stopa seroprotekcije1 93,7%
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 50 VIALS OF SUSPENSION (ANTIGEN) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 50 BOČICA SUSPENZIJE (ANTIGEN)
Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8). 
Pandemrix se smije primijeniti samo u slučajevima kada preporučena godišnja sezonska trovalentna/četverovalentna cjepiva protiv influence nisu dostupna te ako se imunizacija protiv (H1N1)v smatra nužnom (vidjeti dijelove 4.4 i 4.8).
Post-marketing experience with trivalent seasonal influenza vaccines Blood and lymphatic system disorders 
Postmarketinško iskustvo s trovalentnim sezonskim cjepivom protiv influence
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown. 
Nije poznat klinički značaj titra inhibicije hemaglutinacije (HI) 1:40 u djece.
Very common Swelling and pain at the injection site, fatigue, shivering 
Oticanje i bol na mjestu injiciranja, umor, drhtanje
No data are available. 
Nema dostupnih podataka o primjeni.
It is recommended to equip the syringe with a needle gauge not larger than 23-G. 
Ne preporučuje se koristiti štrcaljku s iglom čiji je promjer veći od 23-G.
Month N=24 
mjesec N=24
2.5 ml After mixing with adjuvant emulsion: 10 doses of 0.5 ml 
2,5 ml Nakon miješanja s emulzijom adjuvansa: 10 doza od 0,5 ml
Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. The immune response to Fluarix was satisfactory. 
Podaci dobiveni pri istovremenoj primjeni cjepiva Pandemrix (H1N1)v i neadjuvantiranog sezonskog cjepiva protiv influence (Fluarix, cjepivo s fragmentiranim virionom) u zdravih odraslih osoba u dobi starijoj od 60 godina nije ukazivala na značajnija ometanja imunološkog odgovora na Pandemrix (H1N1)v.
There are no data with Pandemrix using the subcutaneous route. 
Nema podataka o primjeni cjepiva Pandemrix supkutanim putem.
NA NA NA NA 21.5% 20.6% 42.1% 45.6% 
ND ND ND ND 21,5% 20,6% 42,1% 45,6%
If a second dose is administered there should be an interval of at least three weeks between the first and the second dose. 
Ako se primjenjuje druga doza, između prve i druge doze treba proći najmanje tri tjedna.
NA NA NA NA 15.4% 14.3% 14.0% 22.8% 
ND ND ND ND 15,4% 14,3% 14.0% 22,8%
NA NA NA NA 27.7% 20.6% 35.1% 49.1% 
ND ND ND ND 27,7% 20,6% 35,1% 49,1%
The ability to induce protection against homologous and heterologous vaccine strains was assessed nonclinically using ferret challenge models. 
U nekliničkom ispitivanju procjenjivala se sposobnost induciranja zaštite protiv homolognih i heterolognih sojeva u cjepivu pomoću modela na tvorovima.
unexpected severe adverse reactions, adverse events of special interest (AESI). 
• Prijavljivanje nuspojava prema značaju; tj. fatalne i životno ugrožavajuće nuspojave, teške neočekivane nuspojave, nuspojave od posebnog interesa (AESI).
Please consult the Product Information of Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted). 
Molimo da pogledate Informacije o lijeku za cjepivo protiv pandemijske gripe (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano).
Month N=10 
mjesec N=10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING PACK OF 25 VIALS OF EMULSION (ADJUVANT) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU PAKIRANJE S 25 BOČICA S EMULZIJOM (ADJUVANS)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pandemrix 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Emulzija adjuvansa za Pandemrix i.m.
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 Twelve months after the first dose, the seroprotection rate was as follows: 
1stopa seroprotekcije: udio ispitanika s titrom inhibicije hemaglutinacije (HI) ≥1:40 Dvanaest mjeseci nakon prve doze zabilježene su sljedeće vrijednosti stopa seroprotekcije:
After mixing, use the vaccine within 24 hours. 
Nakon miješanja, cjepivo primijenite unutar 24 sata.
In the event of other variation being observed, discard the vaccine. 
U slučaju da primijetite bilo kakvo odstupanje, bacite cjepivo.
Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see section 4.8). 
Pandemrix se smije primijeniti samo u slučajevima kada preporučena godišnja sezonska trovalentna/četverovalentna cjepiva protiv influence nisu dostupna te ako se imunizacija protiv (H1N1)v smatra nužnom (vidjeti dio 4.8).
Antigen suspension for Pandemrix Influenza vaccine 
Suspenzija antigena za Pandemrix
In a clinical study (D-Pan-H1N1-009) in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) or adult dose (i.e. 0.5 ml) of Pandemrix were as follows: 
U kliničkom ispitivanju (D-Pan-H1N1-009) zdrave djece u dobi od 6 do 35 mjeseci (stratificirane prema dobi u grupe od 6 do 11, 12 do 23 i 24 do 35 mjeseci) odgovor anti-HA protutijela 21 dan nakon prve i druge polovice doze za odrasle (tj. 0,25 ml) ili doze za odrasle (tj. 0,5 ml) cjepiva Pandemrix bio je:
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 sadržaja 1 bočice suspenzije (2,5 ml) i 1 bočice emulzije (2,5 ml) odgovara količini za 10 doza cjepiva (5 ml).
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber). 
- dva pakiranja s 25 bočica (staklo tip I) od 2,5 ml emulzije s čepom (butil guma).
How to store Pandemrix 
Kako čuvati Pandemrix
Children aged from 6 months to 9 years 
Djeca u dobi od 6 mjeseci do 9 godina
NA NA NA NA 13.8% 7.9% 15.8% 14.0% 
ND ND ND ND 13,8% 7,9% 15,8% 14,0%
Very common Headache Uncommon Paraesthesia, dizziness 
Glavobolja Manje često Parestezija, omaglica
20.0% 17.9% 15.1% 32.7% NA NA NA NA 
20,0% 17,9% 15,1% 32,7% ND ND ND ND
Half adult dose 
Pola doze za odrasle
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, gentamicin sulphate and sodium deoxycholate). 
Potreban je oprez pri primjeni ovog cjepiva u osoba s poznatom preosjetljivošću (pored anafilaktičke reakcije) na djelatnu tvar, neku od pomoćnih tvari navedenih u dijelu 6.1, tiomersal i ostatne tvari (jaja i pileće proteine, ovalbumin, formaldehid, gentamicin sulfat i natrijev deoksikolat).
The vial containing the adjuvant should be maintained in upside down position to facilitate the withdrawal of the full content. 
Bočica koja sadrži adjuvans treba se držati u okomitom položaju gornjom stranom okrenuta prema dolje,
NA NA NA NA 16.9% 17.5% 22.8% 28.1% 
ND ND ND ND 16,9% 17,5% 22,8% 28,1%
Six months after the first dose, the seroprotection rate was as follows: 
Šest mjeseci nakon prve doze zabilježene su slijedeće vrijednosti stopa seroprotekcije:
STATEMENT OF ACTIVE SUBSTANCE(S) Split influenza virus, inactivated, containing antigen* equivalent to 3.75 micrograms haemagglutinin/dose *Antigen: A/California/07/2009 (H1N1) derived strain used NYMCX-179A 
TVARI fragmentirani virus influence, inaktivirani, sadrži antigen* koji odgovara: 3,75 mikrograma hemaglutanina/doza *Antigen: A/California/07/2009 (H1N1) iz kojeg je izveden korišten soj NYMCX-179A