natgillin/translations-raw huggingface dataset:
Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C. 
Dokazano je bilo, da je cepivo, pripravljeno za uporabo, pri temperaturi 30°C kemijsko in fizikalno stabilno 24 ur.
Persons previously vaccinated with one or two doses of AS03-containing vaccine containing HA derived from a different clade of the same subtype 
Osebe, predhodno cepljene z enim ali dvema odmerkoma cepiva z AS03, ki je vsebovalo HA-antigen iz drugega klada istega podtipa
Non-clinical data obtained with Pumarix reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period). 
Predklinični podatki, pridobljeni s cepivom Pumarix, na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti in toksičnosti pri ponavljajočih se odmerkih, lokalne tolerance, plodnosti pri samicah, embrio-fetalne in postnatalne toksičnosti (do konca obdobja laktacije) ne kažejo posebnega tveganja za človeka.
Clinical data in children less than 6 years of age who received two doses of another Pandemic influenza vaccine (H5N1 manufactured in Dresden, Germany) indicate an increase in frequency of fever (axillary≥38°C) after the administration of the second dose. 
Klinični podatki otrok, mlajših od 6 let, ki so prejeli dva odmerka drugega cepiva proti pandemski gripi (H5N1, izdelanega v Dresdnu v Nemčiji) kažejo večjo pogostnost zvišane telesne temperature (aksilarno ≥ 38 °C) po uporabi drugega odmerka.
Outside of the pandemic period, the normal PSUR periodicity and format will be maintained, with a specific review of AESI and possible adverse events related to adjuvants. 
Redna posodobljena poročila o varnosti zdravila (PSUR) Izven obdobja pandemije bo vzdrževana normalna periodičnost in oblika PSUR, s posebnim pregledom neželenih učinkov posebnega pomena (AESI) in možnih neželenih učinkov, povezanih z adjuvansi.
The mixed vaccine can either be stored in a refrigerator (2°C - 8°C) or at room temperature (25°C - 30°C). 
Pripravljeno cepivo lahko shranjujete v hladilniku (2°C - 8°C) ali na sobni temperaturi (25 °C - 30 °C).
Each vaccine dose of 0.5 ml is withdrawn into a 1 ml syringe for injection and administered intramuscularly. 
Vsak odmerek (0,5 ml cepiva) izvlecite v 1-ml injekcijsko brizgo in injicirajte intramuskularno.
• Adults from 18 years onwards: you will receive two doses of Pumarix. 
• Odrasli, starejši od 18 let: prejeli boste dva odmerka cepiva Pumarix.
Proportional reporting ratio (PRR), Information Component (IC) or the Empirical Bayesian Geometric Mean (EBMG)); this is not mandatory as all MAHs do not yet have this capability. 
- Če je možno, je potrebno predložiti merilo za razmerje relativnega poročanja signalov za vsak poročani PT (npr. t.i. Proportional reporting ratio (PRR), Information Component (IC) ali Empirical Bayesian Geometric Mean (EBMG)); to ni obvezno, saj vsi imetniki dovoljenja za
Immune response to A/Vietnam/1194/2004 
Imunski odziv proti A/Vietnam/1194/2004
A minor infection such as a cold should not be a problem, but your doctor will advise whether you could still be vaccinated with Pumarix. 
Blažja okužba, npr. prehlad, ne predstavlja težave, vendar se pred cepljenjem s cepivom Pumarix o tem vseeno posvetujte s svojim zdravnikom.
A titre of 1:80 was achieved in 95.7% of subjects at days 21 and 42 and in 85.1% at day 180. 
Titer 1:80 je bil dosežen pri 95,7 % preiskovancev na dan 21 in 42 ter pri 85,1 % na dan 180.
Pumarix consists of two containers: 
Cepivo Pumarix je na voljo v dveh vsebnikih:
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. 
Uporaba drugega polovičnega odmerka za odrasle ali odmerka za odrasle ni povečala reaktogenosti, razen deležev splošnih simptomov, ki so bili večji po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri mlajših od 6 let.
Very common: may affect more than 1 in 10 people 
Zelo pogosti:pojavijo se lahko pri več kot 1 od 10 oseb
It is recommended to equip the syringe with a needle gauge not larger than 23 
Injekcijsko brizgo je priporočljivo opremiti z iglo, ki ni večja od 23-G.
However, in a pandemic situation, it may be appropriate to give the vaccine provided that facilities for resuscitation should be immediately available in case of need. 
Toda v primeru pandemije je lahko vseeno ustrezno dati cepivo pod pogojem, da je nemudoma na voljo vse,
The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary. 
Evropska agencija za zdravila bo letno pregledala vse nove podatke o tem cepivu in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines). 
Spodaj so našteti neželeni učinki, zabeleženi v kliničnih študijah z modelnim cepivom (za več podatkov o modelnih cepivih glej poglavje 5.1).
• Adults from 18 years onwards: you will receive one dose of Pumarix. 
• Odrasli, starejši od 18 let: prejeli boste en odmerek cepiva Pumarix.
A titre of 1:80 was achieved in 84.2% of subjects aged 18-60 years and in 92.6% of subjects aged >60 years. 
Titer 1:80 je bil dosežen pri 84,2 % preiskovancev, starih od 18 do 60 let, in pri 92,6 % preiskovancev, starih > 60 let.
Pumarix contains sodium and potassium 
Cepivo Pumarix vsebuje natrij in kalij
• Pain in the chest 
• bolečina v prsnem košu,
Pumarix contains thiomersal as a preservative and it is possible that you may experience an allergic reaction. 
Cepivo Pumarix vsebuje tiomersal Cepivo Pumarix vsebuje konzervans tiomersal in mogoče je, da se vam pojavi alergijska reakcija.
NAME OF THE MEDICINAL PRODUCT Emulsion for emulsion for injection for Pumarix 
IME ZDRAVILA Emulzija za emulzijo za injiciranje za cepivo Pumarix
What Pumarix is and what it is used for 
Kaj je cepivo Pumarix in za kaj ga uporabljamo Kaj je cepivo Pumarix in za kaj ga uporabljamo
Immune response to A/Indonesia/5/2005 Day 42 N=145 
Imunski odziv proti A/Indonesia/5/2005 42. dan n = 145
Adverse reactions 
Alergijske reakcije
4.7 Effects on ability to drive and use machines Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive 
Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje ali upravljanja s stroji.
The per-dose frequency of adverse reactions was as follows: 
Pogostnost neželenih učinkov na prejeti odmerek je bila naslednja:
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: 
V študiji konsistentnosti (Q-Pan-H5N1-002) so bili odzivi anti-hemaglutininskih (anti-HA) protiteles enaindvajset dni in 6 mesecev po drugem odmerku naslednji:
From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported: 
Po pridobitvi dovoljenja za promet s cepivi z AS03 z vsebnostjo 3,75 µg HA, pridobljenimi iz A/California/7/2009 (H1N1), so bili opisani naslednji neželeni učinki:
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 
Previdnost je potrebna pri cepljenju oseb z znano preobčutljivostjo (poleg anafilaktične reakcije) za zdravilno učinkovino, katerokoli pomožno snov, navedeno v poglavju 6.1, tiomersal ali ostanke (jajčne in piščančje beljakovine, ovalbumin, formaldehid, in natrijev deoksiholat).
However, if this needs to happen, the other vaccine will be injected into the other arm. Any side effects that happen may be 
Če pa je to potrebno, vam bodo drugo cepivo injicirali v drugo roko.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
They may also happen with Pumarix. 
Lahko se pojavijo tudi pri cepivu Pumarix.
This can cause skin rashes, joint pain and 
Ta lahko povzroči izpuščaje na koži, bolečine v sklepih in težave z
Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be brought to room temperature (allow a minimum of 15 minutes). 
Navodila za mešanje in injiciranje cepiva: Preden obe komponenti zmešate skupaj, morate emulzijo (adjuvans) in suspenzijo (antigen) vsaj 15 minut pustiti na sobni temperaturi.
Forty-two days after the booster dose, the seroprotection rate against 
Deset dni po obnovitvenem odmerku je bil delež serološke zaščite proti
• Shortness of breath 
• težko dihanje,
2 4-fold increase in serum neutralising antibody titre 3 % of subjects reaching a serum neutralising antibody titre of at least 1:80 
3 % preiskovancev, ki so dosegli serumski titer nevtralizirajočih protiteles vsaj 1:80
Adults 
Otroci
After mixing with adjuvant emulsion: 10 doses of 0.5 ml 
2,5 ml Po premešanju z emulzijo adjuvansa: 10 odmerkov po 0,5 ml
If the pandemic situation allows, immunisation shall be postponed in patients with severe febrile 
Če pandemske razmere dopuščajo, je treba cepljenje odložiti pri bolnikih, ki imajo hujše obolenje z zvišano telesno temperaturo ali akutno okužbo.
Therefore monitoring of temperature and measures to lower the temperature (such as giving paracetamol or other medicines that lower fever) after each 
Zato je otroku po vsakem odmerku cepiva priporočljivo spremljati telesno temperaturo in uporabiti ukrepe za njeno znižanje (npr. otroku dati paracetamol ali drugo zdravilo za znižanje zvišane telesne temperature).
Day 180 N=353 
180. dan n = 353
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 
Po drugem odmerku ni bilo povečanja, ne glede na to, ali so otroci dobili polovični ali celotni odmerek za odrasle, razen nekaterih neželenih učinkov, ki so bili pogostejši po drugem odmerku, zlasti kar zadeva deleže zvišane telesne temperature pri otrocih, mlajših od 6 let.
Day 42 N=479 
42. dan n = 479
In adults 18 to 64 years of age, the most frequently reported adverse reactions after vaccination were injection site pain (80.5%), muscle aches (37.2%), fatigue (25.2%), headache (25.1%), joint pain 
Pri odraslih, starih od 18 do 64 let, so bili najpogosteje zabeleženi neželeni učinki cepljenja bolečina na mestu injiciranja (80,5 %), bolečine v mišicah (37,2 %), utrujenost (25,2 %), glavobol (25,1 %), bolečine v sklepih (17,7 %) in drgetanje (11,1 %).
Serious unexpected reactions (PTs) 
Neželeni učinki posebnega pomena (PT) Resninepričakovani neželeni učinki (PT).
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. 
Utemeljitev priporočila za spremembo pogojev dovoljenja za promet z zdravilom Na podlagi znanstvenih zaključkov za cepivo Pumarix je CHMP mnenja, da je razmerje med koristjo in tveganjem za cepivo, v katerem so zdravilna učinkovina prečiščene antigenske frakcije inaktiviranega razcepljenega viriona A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2, ugodno, ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
No post-marketing surveillance data are available following Pumarix administration. 
Podatki o spremljanju cepiva Pumarix po pridobitvi dovoljenja za promet niso na voljo.
If the mixed vaccine is stored in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) 
Če pripravljeno cepivo shranjujete v hladilniku, ga je treba vsaj 15 minut pustiti na sobni temperaturi preden izvlečete posamezni
Immune response against A/Indonesia/5/2005 (H5N1) 
Imunski odziv proti A/Indonesia/5/2005 (H5N1): Odrasli
Rue de l'Institut 89 B-1330 Rixensart Belgium 
GlaxoSmithKline Biologicals S.A. 89, rue de l'Institut B-1330 Rixensart Belgija
During a pandemic situation (Phase 6 of the WHO global Influenza preparedness plan), bi-weekly "simplified PSUR" accompanied by a summary of vaccine distribution will be provided according to the cRMP guidance (Doc. 
Med obdobjem pandemije (faza 6 globalnega načrta SZO o pripravljenosti na gripo) bodo v skladu s smernicami cRMP (doc.ref.EMEA/32706/2007 za pandemijo) predloženi dvotedenski »poenostavljeni PSUR«, ki jim bo priložen povzetek distribucije cepiva.
In another clinical study (Q-Pan-H5N1-001), the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows: 
V drugi klinični študiji (Q-Pan-H5N1-001) so bili odzivi antihemaglutininskih (anti-HA) protiteles pri preiskovancih, starih od 18-64 let, naslednji:
• When new information is received that may impact on the current Safety Specification, 
• Po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja.
Day 180 N=104 
180. dan n = 104
Half dose 
7 Polovični odmerek
• Tingling or numbness of the hands or feet 
• nespečnost, • mravljinčenje ali odrevenelost v rokah ali nogah,
3.75 micrograms** 
(3,75 mikrogramov HA).
Clinical studies have evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 in subjects from the age of 18 years onwards following a 0, 21 days schedule. 
S kliničnimi študijami so ocenili imunogenost cepiva z adjuvansom AS03 in vsebnostjo 3,75 µg HA iz A/Indonesia/5/2005 pri preiskovancih, starejših od 18 let po shemi 0, 21 dni.
• Reactions where the injection was given such as bruising, a hard lump, itching, warmth 
• reakcije na mestu injiciranja kot so modrica, zatrdlina, srbenje, občutek toplote,
In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following 
Med spremljanjem interpandemskih trivalentnih cepiv po pridobitvi dovoljenja za promet so poročali tudi o naslednjih neželenih učinkih:
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 
Pri odraslih, starejših od 64 let, so bili najpogostejši neželeni učinki po cepljenju bolečina na mestu injiciranja (58,0 %), bolečine v mišicah ( 19,7 %), utrujenost (13,5 %), glavobol (12,4 %) in bolečine v sklepih (10,3 %).
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: 
V drugi klinični študiji (Q-Pan-H5N1-001) so bili odzivi anti-HA proti A/Vietnam/1194/2004 po uporabi cepiv z adjuvansom AS03 z vsebnostjo 3,75 µg iz A/Indonesia/5/2005 naslednji:
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. 
V študiji konsistentnosti (Q-Pan-H5N1-002) je bil dosežen 4-kraten porast titra nevtralizirajočih protiteles v serumu proti A/Vietnam/1194/2004 na dan 42 pri 65,5 % preiskovancev, starih od 18 do 60 let, in pri 24,1 % preiskovancev, starejših od 60 let.
See sections 4.8 
Glejte poglavji 4.8 in 5.1.
Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 (H5N1): 
Navzkrižni imunski odzivi na cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/5/2005 (H5N1):
SCIENTIFIC CONCLUSIONS AND GROUNDS RECOMMENDING THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION 
ZNANSTVENI ZAKLJUČKI IN UTEMELJITEV PRIPOROČILA ZA SPREMEMBO
At day 42, 100% of subjects aged 18-60 years and 96.4% of subjects aged >60 years 
Na dan 42 je imelo titer vsaj 1:80 100 % preiskovancev, starih od 18-60 let, in 96,4 % preiskovancev, starih > 60 let.
The suspension is a translucent to off white opalescent suspension, which may sediment slightly. 
suspenzija in emulzija za emulzijo za injiciranje Suspenzija je prozorna do sivo bela opalescentna suspenzija, ki lahko rahlo sedimentira.
In other clinical studies where children 6 months to 17 years received another pandemic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose 
V drugih kliničnih študijah, v katerih so otroci v starosti od 6 mesecev do 17 let dobili drugo cepivo proti pandemski gripi (H5N1 A/Indonesia/05/2005, izdelano v Dresdnu v Nemčiji), so pri otrocih, mlajših od 6 let, po drugem odmerku opažali večjo pogostnost nekaterih neželenih učinkov (vključno z bolečino na mestu injiciranja, pordelostjo in zvišano telesno temperaturo).
This is as long as medical treatment is available straight away, in case you have an allergic reaction. 
- Vendar boste v primeru pandemije morda vseeno dobili cepivo, pod pogojem, da je zdravljenje z zdravili nemudoma na voljo, če bi se vam pojavila alergijska reakcija.
The immunological response may be diminished if the patient is undergoing immunosuppressant 
Če bolnik prejema imunosupresivno zdravljenje, je imunski odziv lahko manjši.
The results of this heterologous challenge study indicate 80.7%-100% protection in all adjuvanted candidate vaccines compared to 43% protection with the non adjuvanted vaccine, showing the benefit of AS03 
zaščito pri vseh kandidatnih cepivih z adjuvansom, v primerjavi s 43-odstotno zaščito pri cepivih brez adjuvansa, kar kaže na korist adjuvansa AS03.
Mix with adjuvant emulsion before use 
Pred uporabo zmešajte skupaj z emulzijo adjuvansa.
Seroprotection rate1 Seroconversion rate2 
GMT1 Delež serokonverzije2
1seroprotection rate (i.e. proportion of subjects with HI titre ≥ 1:40); 
1Delež serološke zaščite (tj. delež preiskovancev s titrom HI ≥ 1:40),
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 
Zato je mlajšim otrokom (npr. do približno 6. leta starosti) po cepljenju priporočljivo kontrolirati telesno temperaturo in uporabiti ukrepe za znižanje zvišane telesne temperature (npr. antipiretična zdravila, če se zdi klinično potrebno).
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP). 
ki so podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2.
Redness 
razdražljivost
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
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. 
Ne glede na to, ali sta bila 6 mesecev prej uporabljena eden ali dva odmerka primarnega cepiva so bili deleži serološke zaščite proti A/Indonesia po odmerku cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 > 80 %, deleži serološke zaščite proti A/Vietnam po odmerku cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005 pa > 90 %.
Excipient with known effect: the vaccine contains 5 micrograms thiomersal For the full list of excipients see section 6.1. 
Pomožne snovi z znanimi učinki: Cepivo vsebuje 5 mikrogramov tiomersala.
Nervous system disorders Very common: headache Uncommon: dizziness, paraesthesia 
Zelo pogosti: glavobol Občasni: omotica, parestezije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Pumarix 
IME ZDRAVILA IN POT(I) UPORABE Emulzija adjuvansa za cepivo Pumarix i.m.
Day 180 N=141 
180. dan n = 141
Mix into Antigen suspension before use 
Pred uporabo zmešajte skupaj s suspenzijo antigena.
Full dose N=29 
Polni odmerek n = 29
Detailed information on this medicine is available on the European Medicines Agency web site: 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing four different doses of H5N1 antigen (3.75, 1.5, 0.6 and 0.24 µg of HA antigen) adjuvanted with half dose of AS03. 
V tem preskusu zaščite so bele dihurje (šest belih dihurjev/skupino) intramuskularno cepili s kandidatnim cepivom, ki je vsebovalo štiri različne odmerke H5N1 antigena (3,75; 1,5; 0,6 in 0,24 µg
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
1 Delež serološke zaščite: delež preiskovancev s titrom inhibicije hemaglutinacije (HI) ≥ 1:40.
What you need to know before you are given Pumarix 
Kaj morate vedeti, preden boste dobili cepivo Pumarix Cepiva Pumarix ne smete dobiti:
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre 
3Faktor serokonverzije: razmerje med geometrično sredino titra (GMT - geometric mean titre) po cepljenju in GMT pred cepljenjem.
Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com 
Tel: + 420 2 22 00 11 11 czmail@gsk.com
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 
En odmerek cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Indonesia/05/2005, izdelanega po drugačnem postopku, uporabljen po enem ali dveh odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004, izdelanega po drugačnem postopku
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. 
V klinični študiji (D-Pan-H5N1-012) so preiskovanci, stari od 18 do 60 let, dobili cepivo z adjuvansom AS03 z vsebnostjo 3,75 µg HA bodisi iz A/Vietnam/1194/2004 bodisi iz Indonesia/5/2005 šest mesecev po enem ali dveh primarnih odmerkih cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA iz A/Vietnam/1194/2004 na dan 0 (en odmerek) oz. na dan 0 in 21 (dva odmerka).
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. 
V tem preskusu zaščite so bele dihurje (šest belih dihurjev/skupino) intramuskularno cepili s kandidatnim cepivom, ki je vsebovalo tri različne odmerke H5N1 antigena (7,5; 3,8 in 1,9 µg HA
- Reporting to be fortnightly for the first 3 months of the pandemic. 
- V prvih treh mesecih pandemije naj bo poročanje štirinajstdnevno.